WO2014033747A2 - Method and system for integrated clinical trial management - Google Patents

Method and system for integrated clinical trial management Download PDF

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Publication number
WO2014033747A2
WO2014033747A2 PCT/IN2013/000485 IN2013000485W WO2014033747A2 WO 2014033747 A2 WO2014033747 A2 WO 2014033747A2 IN 2013000485 W IN2013000485 W IN 2013000485W WO 2014033747 A2 WO2014033747 A2 WO 2014033747A2
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WO
WIPO (PCT)
Prior art keywords
module
data
master
study
plan
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PCT/IN2013/000485
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French (fr)
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WO2014033747A4 (en
WO2014033747A3 (en
Inventor
Nidhi SAXENA
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Karmic Labs Pvt. Ltd.
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Publication of WO2014033747A2 publication Critical patent/WO2014033747A2/en
Publication of WO2014033747A3 publication Critical patent/WO2014033747A3/en
Publication of WO2014033747A4 publication Critical patent/WO2014033747A4/en

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/60—ICT specially adapted for the handling or processing of medical references relating to pathologies

Definitions

  • the present invention relates to the clinical trials and system and method for managing clinical trials.
  • a system for integral clinical trial the system comprise of a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user, an admi module to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial; a master module* the master unit configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates, an electronic trial master module, a CTMS module, the CTMS module comprising of a feasibility module, the feasibility module to generate site feasibility study and report plan, a CPP module* the CPP module to generate study plan, a Budget module, the Budget module to generate Budget plan and a Monitoring module, the Monitoring module to generate monitoring plan,
  • electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format
  • a Repository module comprising of server, the server configured for storing user profiles of the plurality of users, periodically updating the received input data and generated report
  • a Dashboard and report module the Dashboard and report module to generate and maintain dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration
  • a Regdex module the Regdex module to store country wise regulatory bodies and regulatory details
  • Figure 1 shows a system for Integrated Clinical trial
  • Figure 2 shows data flow for Integrated Clinical trial
  • the solution may be a clinical trial management system, wherein the most efficient solution would have to be an integrated clinical trial management system. This provides the maximum penetration and ease of use.
  • the present invention is a system that presents as a single interface into a variety of applications typically used in the clinical trial process; or it may be a system that gathers, consolidates, and presents information from disparate sources.
  • an integrated system for clinical trials would have a single point of entry into all related applications or modules and utilize data consolidated within a single database.
  • the embodiments herein provide an integrated method and system for clinical trial management. Further the embodiments may be easily implemented in various clinical structures. The method of the invention may also be implemented as application performed by a stand alone or embedded system. [0020] The invention described herein is explained using specific exemplary details for better understanding. However, the invention disclosed can be worked on by a person skilled in the art without the use of these specific details. [0021] References in the specification to "one embodiment” or “an embodiment” means that a particular feature, structure, characteristic, or function described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.
  • these quantities take the form of data stored/transferred in the form of electrical, magnetic, or optical signals capable of being stored, transferred, combined, and otherwise manipulated through mechanical and electrical components of the computer system; and the term computer system includes general purpose as well as special purpose data processing machines, switches, and the like, that are standalone, adjunct or embedded.
  • the present system and the method thereof is innovative next generation eClinical System that integrates core Clinical Trial Management & Operational Analytics, Electronic/Paper Hybrid Data Management, Electronic Trial Master File, SDTM Mapping and all Unified Clinical Data Warehousing functionalities into a single unified system.
  • the present system and the method thereof may be, 21 CFR Part 11, CDASH/CDISC and SDTM Compliant, Web-Enabled Clinical Suite with integrated Clinical Trial Management, Operational Analytics, Data Management, Electronic Trial Master File and Clinical and Operational Data Warehousing functionalities designed especially to support end-to-end Global Clinical Operations, Data Management and Project Management requirements.
  • the system may support end-to-end operational activities from project set-up, planning, budgeting, execution, performance analytics and reporting for all clinical trials apart from storing all clinical and operational enterprise data as well as electronic trial master files.
  • the system and the method thereof is a next generation, 21 CFR Part 11 compliant systems with an ODM compliant Clinical Data Repository.
  • the invention described herewith details functionalities of the system and the method thereof.
  • the system and the method thereof is standalone with integrated CTMS systems with inter-linkage at System and / or Data level and this is the first integrated system and the method implemented thereof with the entire CTMS functionality fully integrated into a single system.
  • the system and the method thereof of the present invention as described herewith is an integrated CTMS system with a common Master Analytics Dashboard and is planned to make the Clinical Operations and Data Management functions fully integrated and automated and is also to considered as a building block to develop a Clinical and Non- Clinical Trial Repository.
  • the system adheres to the following standards:
  • the system and the method thereof of the present invention as described herewith is comprising user interface Module, Audit trial module, Masters module, CTMS module, EDC/CDMS Module, Interactive Voice / Web Response module Dashboards and Reports module, electronic Trail Master file module Repository module, and Rolodex module as Functional modules implementing the associative functionality confining overall functionality of the system and the method thereof.
  • the system may designed to adapt Full Scale CTMS Capabilities.
  • the system and the method thereof may attain End-to-end CTMS capabilities to handle project management, site management, resource management, performance management, quality assurance, SLA tracking & budgeting activities.
  • the system and the method thereof may provide automated workflows for all critical tasks and activities with tollgate based approval, sophisticated reporting across 20+ critical operational/quality metrics with 4-level drill down and SLA deviations and root cause analysis to enable actionable governance and exception management.
  • the system and the method thereof may have full scale EDC/CDMS capabilities.
  • the system and the method thereof may have full scale Interactive Voice / Web Response capabilities.
  • the system and the method thereof may have full scale Dashboards and Reports presentation capabilities.
  • the system and the method thereof may have full scale electronic Trail Master set-up capabilities.
  • the system may be US-FDA 21 CFR Part 11 Complaint System.
  • the system may be fully validated with detailed IQ, OQ, PQ documentation, Electronic Signatures & Records, Secure, Roles Based Access, Authorit Checks, through defined methodologies.
  • the system and the method thereof may provide Audit Trail for all process activities.
  • the system may be API-based Modular System which may have ease of adding new system modules quickly and efficiently and may also have highly customizable reporting and dashboards.
  • the system and the method thereof may be Intuitive, User Friendly Interface for CRF & Edit Checks Setup, may have Re-usable Frameworks for Item, Panels, Visits & Pages, may required minimum programming for Study Set-up and may have high system scalability.
  • the system and the method thereof may be ideal for Multi-Site, Multi-User Trials (> 200 Sites/Users per Trial).
  • the system and the method thereof may support Multiple Data Extraction Formats, CSV, SAS, Others and may perform Medical Coding using Standard Medical Dictionaries MedDRA, WHO*DD.(c.urrent versions)
  • the system modules may include Study Documents Repository module, Study Builder module, Data Capture Module, Query Management Module, Medical Coding module which uses WHO-DD & MedDRA standards, Data Loader Module, Data Extraction Module, Project Dashboards & Reports module, User Profile Set-up & Administration module, Audit Trail module and Database Lock module.
  • the system modules may include Electronic Trial Master File (eTMF) module wherein the eTMF module will allow the entire Trial Master File documents to be scanned and uploaded in an electronic format in structured folders with a directory structure as per the ICH-GCP Clause 8 guidelines.
  • eTMF Electronic Trial Master File
  • the Monitor will be able to review and compare the Site Master File against the Electronic Trial Master File during monitoring visits and update and reconcile the two on the fly by scanning missing documents from the Site Master File and uploading onto the Electronic trial Master File or printing missing documents from the Electronic Trial Master File and placing them in the Site Master File.
  • the site digitizes the Site Master File
  • the system will be able to compare and reconcile the two folders on a periodic, near real time basis and hence keep the two folders completely in sync.
  • the eTMF will further allow for online audits by Karm ' ic Supervisors, Sponsors and Regulators sitting anywhere across the globe.
  • the module establish and provides authorization towards the users to select study allocated to them; to create m-TMF/s-TMF Directory structure as per ICH-GCP requirements; to upload the files as per the m-TMF and s- TMF requirements.
  • the module automatically renames the file as per defined nomenclature and filter criteria.
  • the module allows authorized users to define the work flow and provide access rights to various folders to other study team members; to review/approve or reject the uploaded files; to reconcile the TMF and SMF as per their requirements.
  • the module restricts any and all user from downloading any and all files without approval.
  • the module enables users to raise request for downloading any files and allows authorize users to approve/ reject users request for downloading files.
  • system modules may include Unified Clinical Data Repository & SDTM Mapping Tool
  • the system may have an in-built SDTM Mapping tool that may map data from multiple clinical studies into may be the standard SDT compliant format for regulatory submission of data.
  • This tool may map data field values across all 33 SDTM domains and may offer auto mapping of SDTM value as well as manual mapping where no previous value exists.
  • the method of Integrated clinical trials management may integrate Data collation and meta-analysis capability across multiple trials
  • the method of Integrated clinical trials management may combines may be all core functionalities may be for electronically managing each and every critical process activity required in conducting a clinical trial may be into a single, integrated system with may be a single unified clinical data repository.
  • the system may further have advanced business intelligence and decision support features. Hence it may be a unique and leading edge platform.
  • the method of integrated clinical trials management may perform user management through secured access.
  • the method of integrated clinical trials management may perform navigation administration.
  • the system modules may include Data Security.
  • the system and the method thereof may allow admin to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items wherein the system may have the roles such as but not limited to Investigator, Study Coordinator, Monitor, Data Manager - CRO, Data Manager - Sponsor, Data Associate.
  • the system and the method thereof may allow system admin to create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial.
  • the system modules may include Dashboard and Reports module.
  • the system may allow sponsor to view trial data in the form of dashboards.
  • the Dashboard and Reports module and the method thereof may create reports for Unresolved Queries, Query Ageing Report, Query Count by Subject/ Investigator, Access Rights, Data Entry Status Reports and may allow reports to be exported to PDF.
  • the method of integrated clinical trial management and the system thereof may allow Data Manager/Sponsor to lock studies, lock sites, lock patients
  • the method of integrated clinical trial management and the system thereof may allow all users to view Audit Trail wherein Audit trail may contain old value, new value, reason for change and date and time stamp wherein Audit Trail may be read only and may be exportable to PDF format.
  • the method of integrated clinical trial management and the system thereof may generate notification for SAE recorded.
  • the user interface module of the system and the method thereof of the present invention as described herewith providing access using only valid User ID and Password for the user account include providing access through Secured access interface, Secured access interface having Login consists of fields with proper tab order as Username (Textbox, Mandatory), Password (Textbox, Mandatory), Login (Button) etc.
  • the fields of Secured access interface do not allow the copy and paste entries in the field box for e.g. User cannot copy and paste Username and Password.
  • the Masters Module of the system and the method thereof of the present invention as described herewith comprise of Study, Site, Sponsor, Vendor, Partner CRO and SMO modules.
  • the master module generates and maintains a Study Master.
  • the study master is design to facilitate a user to view Listing of Studies, Create/Modify New Study, Define Sponsor Team, Define Karmic Team, Define CRO Team, Select Vendor & Update Vendor Contacts, Define Task Ownership Matrix, Select Sites / Investigator(s) / Support Staff / I EC, Define Procedures (Lab Procedures / Study Procedures), Define Approval Matrix, Define Study Manual (Start-up Plan, IP Plan, Comm Plan & Annexures), Define Monitoring Plan (Monitoring, Site Plan, Select Visit Schedule)
  • a Site Master of the master module facilitates a user to view Listing of Sites, Create/Modify New Site, Define Therapeutic Area for Area, Define Site Contact, Define EC Languages, Define Investigator, Define Support Staff, Define SMO.
  • a Sponsor Master of the master module facilitates a user to View Listing of Sponsor, Create/Modify New Sponsor, Define Sponsor Team.
  • a Vendor Master of the master module facilitates a user to view Listing of Vendor, Create/Modify Vendor.
  • a Partner CRO Master of the master module facilitates a user to view Listing of Partner CROs, Create/Modify Partner CRO, Define Partner CRO Team, Define CRO Trial Experience.
  • a SMO Master of the master module facilitates a user to view Listing of SMO, Create/Modify New SMO.
  • CTMS Module of the system and the method thereof of the present invention as described herewith comprise of Feasibility, CPP, Budget, and Monitoring modules.
  • the feasibility module is responsible execute the pre - feasibility search wherein the user can use parameter search to filter site / investigator data, finalize the list by select or discard sites I investigator from list and Save the list.
  • the Feasibility module is configured to facilitate user to View Listing of Feasibilities / Export to Excel or PDF, Create/Modify Feasibility, Select Sites, Build Site Feasibility Questionnaire (SFQ), Administer Site Feasibility Questionnaire (SFQ) to Investigators, Edit Site Response, View Final Study Feasibility Report.
  • the Feasibility module selects source of search from the pre-feasibility list or site database, processes the selection by applying study weightages performance parameters to Short list sites and add feasibility scoring, Sorts based on scoring data and saves feasibility sites listing.
  • the module processes the listing to generate Site feasibility report and also allows a use to create new feasibility report by calling in saved feasibility data.
  • the module authorizes the user to add data for sites, to add data in certain sections of report, to save and preview report, to modify or edit report, to submit report for approval.
  • the module sets Documents / process matrix for approval flow, obtains System approval or rejection, and on rejection cites the reason for rejection so that the User can reuse rejected feasibility report, correct and resubmit.
  • the module processes the study site feasibility and maintains a feasibility matrix (Decision weightage criteria) thus to allow the user to have site performance parameter which in turn allows the user to set the calculation weightage (such that all weights total to 00).
  • the Clinical Project Pla module of the CTMS module provides a user Listing of CPPs, allows the user to view CPP Dashboard (Study Specific), select CPP activities in Scope (Study Specific), Create CPP, View/Update Dynamic CPP, and manages Tollgate Migration for various Study Tollgates upon completion of milestones.
  • the module receives user inputs such as but not limited to study information / general information, Start and End dates, key resources etc.
  • plan wherein the plan is formed by creating the scope of the study, selecting and integrating the details from the Role and Responsibility Master, Employee team details, Sponsor team details, Vendors, Sites details and the respective Workflow Matrix. Further, based on the user defined inputs such as but not limited to study information / general information, Start and End dates, key resources etc. site Site Strategy plan has been created which is subjective visit plan.
  • the module also establishes an IP Plan. Th module facilitates user to create Quality Assurance / Study Audit Plan by Monitoring findings and actions for each finding, Project deliverables & document plan and allows user to schedule Study Audit for Internal/ customer Deliverables and SLA.
  • the module further facilitates the user to create Communication Plan (text template), Reporting Plan (text template) Escalation Set-up, and Risk Management Plan.
  • the module allows the user to create Operation masters to support plan / monitor data, Create/Modify Schedule and integrate the Regulatory Plan.
  • the Budget module of the CTMS module manage the Listing of Budget, processes the listing of budget to Add/Edit Study Budget, provides access to the Approved Budget, Tracks Budget (Study Specific).
  • the module processes the respective budget to Add Expenses (Study Specific), View Investigator Payment / Update Investigator Payment / Investigator Payment Summary, Add Lab Procedures / Add Screening Costs / Add Study Procedure Costs and provides Budget Summary (Aggregate / Monthly).
  • the Monitoring module of the CTMS module manages the monitoring plan and processes the plan based on the received inputs to Update Monitoring Plan, to set Monitoring Calendar and Create Monitoring Reports (SIV/SMV/SCV Report), Review & Score Monitorin Report, Perform Monitoring QA and establish Monitoring Performance (Monitor Wise).
  • the monitoring module monitors Site for patient recruitment, checking the investigator target and Monitor visits.
  • the module monitors milestone and tasks, SAE activities, CRF Retrieval, Regulatory Timelines, and Essential Documents & TMF.
  • the modules process the Project budget to enter! manage Study Expenses, enter! manage Site Expenses, create payment flow/! monthly site payment advice and thus monitors the project budget.
  • the module also monitors the Monitoring visits and workf lows through receiving and processing all visit data submissions such as PSSV, SIV, SMV, and SCV.
  • the Hybrid EDC/CDMS Module of the system and the method thereof of the present invention as described herewith comprise of Study Builder, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module to capture patient trial data from polarity of patients from plurality of sites for any of the plurality of study /trial, storing the same in compatible format and making it available to the interfacing and interacting external modules for further processing.
  • system modules may include Study Builder module,
  • the Study Builder module and the method thereof may allow creation of Items, may allow user to edit/modify item for a particular visit, to remove an item for a visit.
  • the Study Builder module and the method thereof may allow creation of code lists, may allow user to add a code list to an item value, creation of CRF pages/screens ⁇ creation of visit structure, to edit a visit structure, to remove/delete a visit structure, to configure Hard checks, to create edit checks of type mandatory (Checks to Capture blank value), to create edit checks to Range Type, to build checks for Date Verification, to configure edit cheeks for Date Comparison, to create validation checks of type Warning, also the system may allow creation and testing of derivations / calculations and may allow admin to publish trial.
  • system modules may include Study Documentation module,
  • the system may allow sponsor and CRO to upload study related documents wherein the Study documentation may be viewable to all users of the study and may allow users to download and print the study documentation.
  • the system modules may include Electronic/Paper Data Capture & Verification Module.
  • the Electronic/Paper Data Capture & Verification Module and the method thereof may allow enrollment of subjects, may allow data entry personnel to perform first pass data entry for enrolled subjects, to perform second pass data entry for enrolled subjects and may allow Data Manager to perform Data verification(Comparison Reconciliation) and update data to database, to enter unscheduled visits data, to upload attachments.
  • Data Manager may only upload the documents with the following but not limited to file types such as .txt, .doc, .docx, .xls, .xlsx, .ppt, .pptx, .pdf,
  • the Electronic/Paper Data Capture & Verification Module and the method thereof may allow users to download attachments, may show read only audit log information for changed data, may calculate derived values, may allow investigator to navigate through visits for data entry, may allow users with print permission to print blank Case Report forms, may upload Data in CSV Formats, and may allow user to add notes and upload files for the CRF fields.
  • the system modules may include Query Management module.
  • the Query Management module and the method thereof may auto-generate queries in batch mode, may allow Data Manager to view Query List, may allow investigator to view Query by per subject, per visit and by status and Query icon may be shown for every field in the CRF form wherein Query icon may follow the color coding scheme.
  • the Query Management module and the method thereof may allow Data Manager create DCF's for Queries, may allow monitor/Data Manager to raise queries, may allow Data Manager to resend queries and change Query status, may allow Data Manager update the Database and close queries, may show the type of the query generated wherein Query type will be "Manual" for manually raised queries and "Auto" for system generated queries and may allow exporting the Query List to PDF format.
  • the system modules may include Medical Coding module.
  • the Medical Coding module and the method thereof may support standard dictionary formats including MedDRA & WHO-DD, may allow auto coding of medical terms matching with the dictionary, may allow Interactive coding of medical terms and may have an option to propagate medical coding.
  • the system modules may include Data Loader module.
  • the Data Loader module and the method thereof may upload data in CSV Format, facilitate the user to create control file to upload the data, to verify data from the loaded data with the CRF data,
  • Integrated clinical trials management system the Data Loader module and the method thereof, may generate queries for out of range and null for the loaded data and allow the user to load data in two ways, Incremental Load and / or Non - Incremental Load.
  • the system through the module may attain functionality to validate data to be loaded, to extract uploaded data.
  • the system through the module may prompt for user notification when load files contain data to be modified.
  • the system through the module may generate a detailed batch report for batches being loaded with the timestamp.
  • the system may allow sponsor to view trial data in the form of dashboardsThe Interactive Voice / Web Response module, the Interactive Voice / Web Response module is configured to constitute any new study specific IVRS / IWRS requirements including study design, sample size, study period, treatment arms/cohorts, visit schedule, dose calculation/modification schedule, IP Plan etc. pertaining to Randomization Schedule Generation and IP Management activities for the said study.
  • the module supports all types of study designs, randomization plans etc. used in clinical trials.
  • the Randomization Sub-Module of the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Provide Inputs and Generate Randomization Schedule as per the Study Protocol or Upload existing Randomization Schedule as per the Study Protocol.
  • the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to create Central Depots(s) and Site Entities as well as set-up the entire Inventory Plan (Initial Inventory Assignment, Batch and Kit Set-up, Minimum Order Quantity/Re-Supply quantity and logic, Shipping & Delivery Lead Time and IP Returns/Destruction etc.) for the study using the IP Management Module.
  • Inventory Plan Initial Inventory Assignment, Batch and Kit Set-up, Minimum Order Quantity/Re-Supply quantity and logic, Shipping & Delivery Lead Time and IP Returns/Destruction etc.
  • the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Screen and Randomize the subjects and generate unique Screening ID and Subject ID as per the defined study design and randomization schedule respectively; to allow visit confirmation and real-time assignment of kits to patients as per the defined randomization schedule; to allow site users to manually raise re-supply request, affect site-to-site IP transfer, site-to- Central Depot transfer etc.; to allow real-time, batch-wise and kit-wise tracking of Inventory status at Central Depot, Site and Subject; to allow authorized users to unblind the subject in the event of an SAE, Safety Event or as determined by the Investigator; to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process.
  • the module is also configured for allow authorized users to generate and extract/auto-email the following reports to study team:
  • the Repository Module of the system and the method thereof of the present invention as described herewith allow storing and retrieval of all Study Documents in a structured manner and is comprise of Staging data store module wherein the incremental data from the source system has been extracted using reusable scripts and loaded in to the Staging data store module for further processing.
  • the Dashboards and report Module of the system and the method thereof of the present invention as described herewith comprise of Master Dashboards, CO Standard Reports, D Standard Reports, Departmental Trackers, and Performance Reports. Master dashboards.
  • the Dashboards Module of the system generates and maintains Dashboards as per the user defined inputs and the study Plan configuration. Generally The module generates and maintain Dashboards for Audit Summary, Compliance Summary, Safety Summary, Medical Writing Summary, Clinical Operations SLA, Data Management SLAs, Regulatory Status Summary, Regulatory Approval Timelines, EC Status Summary, Project Phase Wise Summary, Data Management Statistics, Subject Statistics, Project Tollgate Summary.
  • the module generates Clinical Operations Standard Reports such as but not limited to Subject Logs, Deviation Logs, IP Log, SAE Log, Regulatory Timelines, Recruitment Status, DM Standard Reports, Query Report, AE/ SAE Report, Medical Coding Report, Departmental Report.
  • the module of the System allow authorized departmental users to view/ update the trackers such as but not limited to DM Tracker, BS Tracker, MS Tracker, QA Tracker, VOC Tracker.
  • the module of the system generates Performance Reports by populating the entire task for which Project Team needs to be graded and allow the respective reporting manager to grade the individual team member for CO/DM/BS/MS/QA.
  • the Regdex Module of the system and the method thereof of the present invention as described herewith allows User to add country wise Regulatory Bodies and Regulatory Details.
  • the method comprises the steps of receiving user identification data from a plurality of users, each of th plurality of users providing input at a user interface module through a secured user access, receiving the input from the user interface module, mapping the input wit a plurality of master templates at a master unit, selectively fetching preferred master templates from the plurality of master templates, the master templates fetched based upon pre-determined rules embedded in the master unit and request from at least one of the plurality of users displaying the preferred master templates to the user at the user interface module, storing received input data from the plurality of users for the displayed preferred master templates, processing the received input to convert the received input into a compatible format, receiving the feasibility search request from the plurality of users wherein each of the plurality of users provide plurality of parameters for filtering the site, investigation data, preparing the site feasibility questionnaire based on the plurality of parameters, short list a plurality of sites, add feasibility scoring, generation feasibility matrix; Select clinical priority plan based on the plurality of user inputs, creating the scope
  • a system for integral clinical trial comprise of a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user, an admin module to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial; a master module, the master unit configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates, a CTMS module, the CTMS module comprising of a feasibility module, the feasibility module to generate site feasibility study and report plan, a CPP module, the CPP module to generate study plan, a Budget module, the Budget module to generate Budget plan and a Monitoring module, the Monitoring module to generate monitoring plan, a EDC/CDMS Module comprise of Study Builder, Electronic/Paper Data Capture & Verification Module, Query management
  • the module supports all types of study designs, randomization plans etc. used in clinical trials.
  • the Randomization Sub-Module of the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Provide Inputs and Generate Randomization Schedule as per the Study Protocol or Upload existing Randomization Schedule as per the Study Protocol.
  • the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to create Central DepOts(s) and Site Entities as well as set-up the entire Inventory Plan (Initial Inventory Assignment, Batch and Kit Set-up, Minimum Order Quantity/Re-Supply quantity and logic, Shipping & Delivery Lead Time and IP Returns/Destruction etc.) for the study using the IP Management Module.
  • Inventory Plan Initial Inventory Assignment, Batch and Kit Set-up, Minimum Order Quantity/Re-Supply quantity and logic, Shipping & Delivery Lead Time and IP Returns/Destruction etc.
  • the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Screen and Randomize the subjects and generate unique Screening ID and Subject ID as per the defined study design and randomization schedule respectively; to allow visit confirmation and real-time assignment of kits to patients as per the defined randomization schedule; to allow site users to manually raise re-supply request, affect site-to-site IP transfer, site-to- Central Depot transfer etc.; to allow real-time, batch-wise and kit-wise tracking of Inventory status at Central Depot, Site and Subject; to allow authorized users to unblind th subject in the event of an SAE, Safety Event or as determined by the Investigator; to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process.
  • the module is also configured for allow authorized users to generate and extract/auto-email the reports to study team such as but not limited to Randomization Schedule, Central Depot Inventory Tracker, Site/Subject Inventory Tracker with Supply, Re- Supply, Return and Destruction tracking, Subject Visit Tracker (existing report), Subject Visit Confirmation Report, an electronic trial master module, electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format, upload the files as per the m-TMF and s-TMF requirements, automatically rename the file as per defined nomenclature and filter criteria, define the work flow and provide access rights to various folders to other study team members, review/approve or reject the uploaded files, reconcile the TMF and SMF as per their requirements,
  • the module must not allow any users to download any files without approval and allow users to raise request for downloading any files, approve/ reject users request for downloading files, exhibiting respective dash boards, generating respective plurality of reports, a Repository module, the repository module comprising of server, the server configured for
  • the system for integral clinical trial comprise of a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user,
  • the user interface module comprise of user I/O module for receiving inputs from the user and user authentication module wherein the user authentication module receives input from the user I/O module, fetches the identification details from the administration module and provide secured access when user inputs results in to valid inputs. For invalid entries the module prompts user for the predefined times and then locks the user account.
  • the administration module is a control unit which configures the system and controls overall operation of the systems to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial;
  • the master module configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates.
  • the master unit comprise of Lookup stacks for storing master templates and LUS configuration and extraction logic to configure and extract the master templates in accordance to the requirement.
  • the CTMS module comprising of a feasibility module, the feasibility module to generate site feasibility study and report plan, a CPP module, the CPP module to generate study plan, a Budget module, the Budget module to generate Budget plan and a Monitoring module, the Monitoring module to generate monitoring plan and synchronization unit to control and synchronize the functioning of the CTMS module.
  • the feasibility module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub- masters , constituting the Master.
  • the CPP module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.
  • the Budget module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data— master mapping and integration logic to map the data to the respective sub- masters , constituting the Master.
  • the Monitoring module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.
  • the EDC/CDMS Module of the system and the method thereof of the present invention as described herewith comprise of Study Builder, Electronic/Paper Data Captur & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module.
  • the EDC/CDMS Module is comprise of a communication module configured for receiving data input from the site; a memory unit configured for storing and updating the received input at the Electronic/Paper Hybrid Data Management unit; a processor comprising Study Builder module, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module configured for processing the received input to convert the received input into a format compatible with the Electronic/Paper Hybrid Data Management unit, processing further to maintain and update the data at the memory in compatible format to that of the other interacting modules; and a synchronization unit configured for synchronizing the processed input data with user profiles of the plurality of users to formulate the synchronised data packet carrying user defined data.
  • the Interactive Voice / Web Response module comprising of voice and data communication module and a display module constituting user input - output interface, memory constituting the database to store, maintain and update study specific IVRS / IWRS requirements and Randomization Sub- Module processor for processing the input received to create Central Depots(s) and Site Entities as well as set-up the entire Inventory Plan for the study pertaining to Randomization Schedule Generation and IP Management activities for the said study to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process.
  • the module supports all types of study designs, randomization plans etc. used in clinical trials.
  • the electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format.
  • the electronic trial master module comprise of optical reader interface to capture data and communication module to communicate to the site.
  • the Repository module comprising of server, the server configured for storing user profiles of the plurality of users, periodically updating the received input data and generated report;
  • a Dashboard and report module the Dashboard and report module to generate and maintain dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration.
  • the Dashboard and report module comprise of lookup stacks to store the dashboard and report templates and the final generated dashboard and reports.
  • the Regdex module comprise of a database to store country wise regulatory bodies and regulatory details.
  • the present invention may overcome the challenges of the current scenario of use of for variety of applications typically used in the clinical trial management, through single interface as depicted in the description of the present invention.
  • Modular structure for rapid new module and functionality enhancement include:
  • IVRS Integrated Voice Recognition System
  • IWRS Integrated Web Recognition System

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Abstract

Accordingly it is a principle object of the present invention to overcome the disadvantages and limitations of prior art methods and systems and provide an integrated method and system for Clinical trial management. In accordance with the principles of the present invention wherein the system will carry associative functions of the method for Integral clinical trial management. It is yet another object of the present invention to provide common platform for various clinical trials.

Description

FI ELD OF I NVENTI ON
[0001] The present invention relates to the clinical trials and system and method for managing clinical trials.
BACKGROU N D OF TH E I NVENTI ON
[0002] It is critical that the efficiency, speed, and safety be continually enhanced to make more rapid inroads and progress in battling diseases. One approach to achieving these goals is to ensure that when conducting clinical research, full advantage is taken of the emerging role of technology in obtaining and maintaining medical records, [0003] Generally, the most common professionally managed type of
Clinical research is through several standalone project management systems as each sponsor has different requirements that their Systems Infrastructure must satisfy. [0004] While individual solutions have helped to automate or streamline their particular application areas of the clinical trial process, maintaining multiple systems containing overlapping data and functionality has also brought significant inefficiencies for trial sponsors and technology users. [0005] As the number of relevant applications increases with greater adoption of other technologies, the problems of duplication of data and redundancy in process have increased.
[0006] The current systems have several drawbacks as there are multiple disparate systems with standalone functionalities. There is still no single system that combines all the features into a single integrated Clinical Suite barring perhaps the Oracle Lifesciences Datahub which again does not provide all functionalities in an integrated manner. [0007] Each system gives partial data or vie of the clinical activities of a company or a specific trial and a lot of systems integration effort is required to pull in reports from multiple systems to present a single consolidated view of all clinical activities. [0008] Further, most of these systems involve several manual data entry points over various trial metrics including those relating to Study Performance, Site Performance, Monitoring Performance, Budgets etc. A standalone system only has manually entered trial metrics and reports but no correlation to study and/or patient data.
[0009] The System Dashboards and Reports do not give aggregate numbers across various key metrics across multiple studies. They do not have consolidated reports and dashboards that can give data and trends across multiple studies and hence make it difficult to get an organization or customer wise view besides a study level view.
[0010] The cost of some of the existing integrated systems such as the Oracle Lifesciences Hub is extremely prohibitive and they need significant IT infrastructure, hosting and implementation investment to be deployed.
[0011] For the reasons stated above, which will become apparent to those skilled in the art upon reading and understanding the specification, there is a need in the art for a system and method for integrated clinical trial management that is universally useable, scalable and independent of new technology, uses minimum resources that is easy and cost effectively maintained and is portable and can be deployed anywhere in very little time. S U MMARY OF TH E I NVENTIO
[0012] A system for integral clinical trial, the system comprise of a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user, an admi module to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial; a master module* the master unit configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates, an electronic trial master module, a CTMS module, the CTMS module comprising of a feasibility module, the feasibility module to generate site feasibility study and report plan, a CPP module* the CPP module to generate study plan, a Budget module, the Budget module to generate Budget plan and a Monitoring module, the Monitoring module to generate monitoring plan, The EDC/CDMS Module of the system and the method thereof of the present invention as described herewith comprises of Study Builder, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module to capture patient trial data from polarity of patients from plurality of sites for any of the plurality of study /trial, storing the same in compatible format and making it available to the interfacing and interacting external modules for further processing, Interactive Voice / Web Response module, the Interactive Voice / Web Response module is configured to constitute any new study specific IVRS / IWRS requirements including study design, sample size, study period, treatment arms/cohorts, visit schedule, dose calculation/modification schedule, IP Plan etc. pertaining to Randomization Schedule Generation and IP Management activities for the said study, electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format, a Repository module, the repository module comprising of server, the server configured for storing user profiles of the plurality of users, periodically updating the received input data and generated report, a Dashboard and report module, the Dashboard and report module to generate and maintain dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration, a Regdex module, the Regdex module to store country wise regulatory bodies and regulatory details and
B RI EF DESCRI PTI ON OF TH E DRAWI NGS
[0013] Reference will be made to embodiments of the invention, examples of which may be illustrated in the accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
[0014] The above and other objects, features and advantages of the present invention will be more clearly understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
[0015] Figure 1 shows a system for Integrated Clinical trial
Management as per one embodiment herein. [0016] Figure 2 shows data flow for Integrated Clinical trial
Management as per one embodiment herein.
DESCRI PTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION Abbreviations:
CDMS Clinical Data Management System
CFR Code of Federal Regulation
CO Clinical Operations
CRF Case Report Form
CRO Clinical Research Organization
CSV Comma Separated Values
CTMS Clinical Trial Management System
DM Data Management
EDC Electronic Data Management
FDA Food and Drug Administration
FRS Functional Requirement Specifications
FS Functional Specifications
GCP Good Clinical Practices
IQ Installation Qualification
MVP Master Validation Plan
OQ Operational Qualification PDC Paper Data Capture
PQ Performance Qualification
RFS Request for Services
SAE Serious Adverse Event
SOP Standard Operating Procedure
TS Test Script
URL Universal Resource Locator
URS User Requirements Specifications
VP Validation Plan
[0017] Considering the constraints and practicality of an automated method and system for clinical trials the solution may be a clinical trial management system, wherein the most efficient solution would have to be an integrated clinical trial management system. This provides the maximum penetration and ease of use.
[0018] As per the present invention, the present invention is a system that presents as a single interface into a variety of applications typically used in the clinical trial process; or it may be a system that gathers, consolidates, and presents information from disparate sources. In a perfect world, an integrated system for clinical trials would have a single point of entry into all related applications or modules and utilize data consolidated within a single database.
[0019] The embodiments herein provide an integrated method and system for clinical trial management. Further the embodiments may be easily implemented in various clinical structures. The method of the invention may also be implemented as application performed by a stand alone or embedded system. [0020] The invention described herein is explained using specific exemplary details for better understanding. However, the invention disclosed can be worked on by a person skilled in the art without the use of these specific details. [0021] References in the specification to "one embodiment" or "an embodiment" means that a particular feature, structure, characteristic, or function described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment. [00221 Hereinafter, the preferred embodiments of the present invention will be described in detail. For clear description of the present invention, known constructions and functions will be omitted. [0023] Parts of the description may be presented in terms of operations performed by a standalone / embedded system and / or computer system, using terms such as data, state, link, fault, packet, and the like, consistent with the manner commonly employed by those skilled in the art to convey the substance of their work to others skilled in the art. As is well understood by those skilled in the art, these quantities take the form of data stored/transferred in the form of electrical, magnetic, or optical signals capable of being stored, transferred, combined, and otherwise manipulated through mechanical and electrical components of the computer system; and the term computer system includes general purpose as well as special purpose data processing machines, switches, and the like, that are standalone, adjunct or embedded.
[0024] The words "comprises/comprising", "generates/providing",
"performing" and the words "having/including" when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
[0025] As per one embodiment of the present invention, the present system and the method thereof is innovative next generation eClinical System that integrates core Clinical Trial Management & Operational Analytics, Electronic/Paper Hybrid Data Management, Electronic Trial Master File, SDTM Mapping and all Unified Clinical Data Warehousing functionalities into a single unified system.
[0026] As per one embodiment of the present invention, the present system and the method thereof may be, 21 CFR Part 11, CDASH/CDISC and SDTM Compliant, Web-Enabled Clinical Suite with integrated Clinical Trial Management, Operational Analytics, Data Management, Electronic Trial Master File and Clinical and Operational Data Warehousing functionalities designed especially to support end-to-end Global Clinical Operations, Data Management and Project Management requirements. The system may support end-to-end operational activities from project set-up, planning, budgeting, execution, performance analytics and reporting for all clinical trials apart from storing all clinical and operational enterprise data as well as electronic trial master files. Some of the salient features of the system are:
• US-FDA 21 CFR Part 11 , CDASH & CDISC Complaint System
• Fully validated with comprehensive IQ, OQ, PQ documentation
• Secure* Roles Based Access & Authority Checks
• Electronic Signatures & Records
• Audit Trail for all process activities
• Full Scale Clinical Trial Management System Functionality
• Full Scale Electronic/Paper Hybrid Data Capture Functionality
• Unified data repository with all enterprise wide Masters, Staging, Clinical and Operational data and SDTM mapping tool for mapping of all 33 SDTM domains in the system
• Electronic Trial Master File functionality in line with ICH-GCP Clause 8 requirements for Trial Master Files
[0027] The system and the method thereof is a next generation, 21 CFR Part 11 compliant systems with an ODM compliant Clinical Data Repository. The invention described herewith details functionalities of the system and the method thereof. The system and the method thereof is standalone with integrated CTMS systems with inter-linkage at System and / or Data level and this is the first integrated system and the method implemented thereof with the entire CTMS functionality fully integrated into a single system. The system and the method thereof of the present invention as described herewith is an integrated CTMS system with a common Master Analytics Dashboard and is planned to make the Clinical Operations and Data Management functions fully integrated and automated and is also to considered as a building block to develop a Clinical and Non- Clinical Trial Repository. The system adheres to the following standards:
• USFDA 21 CFR Part 11
- CDISC / CDASH Standards
9 SDTM Standards
9 ODM Schema and Standards
9 HI PAA Standards
[0028] The system and the method thereof of the present invention as described herewith prepare and / or manage clinical data to meet requirements for the following:
• Create and Manage Study, Site, Sponsor, Vendor, Partner CRO etc. in Masters
• Conduct and Manage Feasibility
· Create and Manage Clinical Project Plan, Budgets and Monitoring Activities • Conduct a Study and Maintain Data
• SAE Reconciliation
• SDTM Mapping
• Data Analysis and Reporting
[0029] The system and the method thereof of the present invention as described herewith is comprising user interface Module, Audit trial module, Masters module, CTMS module, EDC/CDMS Module, Interactive Voice / Web Response module Dashboards and Reports module, electronic Trail Master file module Repository module, and Rolodex module as Functional modules implementing the associative functionality confining overall functionality of the system and the method thereof.
[0030] As per another embodiment of the present inventio the system may designed to adapt Full Scale CTMS Capabilities.
[0031] As per one of the embodiment of the present invention, the system and the method thereof may attain End-to-end CTMS capabilities to handle project management, site management, resource management, performance management, quality assurance, SLA tracking & budgeting activities. [0032] As per one of the embodiment of the present invention, the system and the method thereof may provide automated workflows for all critical tasks and activities with tollgate based approval, sophisticated reporting across 20+ critical operational/quality metrics with 4-level drill down and SLA deviations and root cause analysis to enable actionable governance and exception management.
[0033] As per one of the embodiment of the present invention, the system and the method thereof may have full scale EDC/CDMS capabilities.
[0034] As per one of the embodiment of the present invention, the system and the method thereof may have full scale Interactive Voice / Web Response capabilities.
[0035] As per one of the embodiment of the present invention, the system and the method thereof may have full scale Dashboards and Reports presentation capabilities. [0036] As per one of the embodiment of the present invention, the system and the method thereof may have full scale electronic Trail Master set-up capabilities.
[0037] As per one of the embodiment of the present invention, the system may be US-FDA 21 CFR Part 11 Complaint System.
[0038] As per another embodiment of the present invention, the system may be fully validated with detailed IQ, OQ, PQ documentation, Electronic Signatures & Records, Secure, Roles Based Access, Authorit Checks, through defined methodologies.
[0039] As per one of the embodiment of the present invention, the system and the method thereof may provide Audit Trail for all process activities.
[0040] As per one of the embodiment of the present invention, the system may be API-based Modular System which may have ease of adding new system modules quickly and efficiently and may also have highly customizable reporting and dashboards. The system and the method thereof may be Intuitive, User Friendly Interface for CRF & Edit Checks Setup, may have Re-usable Frameworks for Item, Panels, Visits & Pages, may required minimum programming for Study Set-up and may have high system scalability.
[0041] As per one of the embodiment of the present invention, the system and the method thereof may be ideal for Multi-Site, Multi-User Trials (> 200 Sites/Users per Trial). [0042] As per one of the embodiment of the present invention, the system and the method thereof may support Multiple Data Extraction Formats, CSV, SAS, Others and may perform Medical Coding using Standard Medical Dictionaries MedDRA, WHO*DD.(c.urrent versions) [0043] In one another embodiment of the present invention the system modules may include Study Documents Repository module, Study Builder module, Data Capture Module, Query Management Module, Medical Coding module which uses WHO-DD & MedDRA standards, Data Loader Module, Data Extraction Module, Project Dashboards & Reports module, User Profile Set-up & Administration module, Audit Trail module and Database Lock module. [0044] In one another embodiment of the present invention the system modules may include Electronic Trial Master File (eTMF) module wherein the eTMF module will allow the entire Trial Master File documents to be scanned and uploaded in an electronic format in structured folders with a directory structure as per the ICH-GCP Clause 8 guidelines. In other worlds it creates an electronic TMF archiving system. In this system, the Monitor will be able to review and compare the Site Master File against the Electronic Trial Master File during monitoring visits and update and reconcile the two on the fly by scanning missing documents from the Site Master File and uploading onto the Electronic trial Master File or printing missing documents from the Electronic Trial Master File and placing them in the Site Master File. Also at some point of time, if the site digitizes the Site Master File, the system will be able to compare and reconcile the two folders on a periodic, near real time basis and hence keep the two folders completely in sync. The eTMF will further allow for online audits by Karm'ic Supervisors, Sponsors and Regulators sitting anywhere across the globe. The module establish and provides authorization towards the users to select study allocated to them; to create m-TMF/s-TMF Directory structure as per ICH-GCP requirements; to upload the files as per the m-TMF and s- TMF requirements. The module automatically renames the file as per defined nomenclature and filter criteria. The module allows authorized users to define the work flow and provide access rights to various folders to other study team members; to review/approve or reject the uploaded files; to reconcile the TMF and SMF as per their requirements. The module restricts any and all user from downloading any and all files without approval. The module enables users to raise request for downloading any files and allows authorize users to approve/ reject users request for downloading files.
[0045] In one another embodiment of the present invention the system modules may include Unified Clinical Data Repository & SDTM Mapping Tool,
[0046] The method of integrated clinical trials management,
Integrates data from multiple CTMS and EDC/CDMS systems using an ETL layer to create standardized and uniform organizational data.
[0047] As per one of the embodiment of the present invention, the system may have an in-built SDTM Mapping tool that may map data from multiple clinical studies into may be the standard SDT compliant format for regulatory submission of data. This tool may map data field values across all 33 SDTM domains and may offer auto mapping of SDTM value as well as manual mapping where no previous value exists.
[0048] The method of Integrated clinical trials management may integrate Data collation and meta-analysis capability across multiple trials
[0049] The method of Integrated clinical trials management may combines may be all core functionalities may be for electronically managing each and every critical process activity required in conducting a clinical trial may be into a single, integrated system with may be a single unified clinical data repository. The system may further have advanced business intelligence and decision support features. Hence it may be a unique and leading edge platform. [0050] The method of integrated clinical trials management may perform user management through secured access.
[0051] The method of integrated clinical trials management may perform navigation administration. [0052] In one another embodiment of the present invention the system modules may include Data Security.
[0053] As per the method of Integrated clinical trials management described herewith, the system and the method thereof may allow admin to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items wherein the system may have the roles such as but not limited to Investigator, Study Coordinator, Monitor, Data Manager - CRO, Data Manager - Sponsor, Data Associate.
[0054] As per the method of integrated clinical trials management described herewith, the system and the method thereof may allow system admin to create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial.
[0055] As per the system of Integrated clinical trials management described herewith, and the method thereof may allow admin to setup email SMTP configuration, to setup sms configuration, to configure eCRFs i.e. perform study design and also may allow Data manager to create sites for the study and to perform admin tasks for the study. [0056] In one embodiment of the present invention the system modules may include Dashboard and Reports module. [0057] In one another embodiment of the present invention, the system may allow sponsor to view trial data in the form of dashboards.
[0058] As per the Dashboard and Reports module of Integrated clinical trials management system described herewith, the Dashboard and Reports module and the method thereof may create reports for Unresolved Queries, Query Ageing Report, Query Count by Subject/ Investigator, Access Rights, Data Entry Status Reports and may allow reports to be exported to PDF. [0059] The method of integrated clinical trial management and the system thereof may allow Data Manager/Sponsor to lock studies, lock sites, lock patients
[0060] The method of integrated clinical trial management and the system thereof may allow all users to view Audit Trail wherein Audit trail may contain old value, new value, reason for change and date and time stamp wherein Audit Trail may be read only and may be exportable to PDF format.
[0061] The method of integrated clinical trial management and the system thereof may generate notification for SAE recorded.
[0062] The user interface module of the system and the method thereof of the present invention as described herewith providing access using only valid User ID and Password for the user account include providing access through Secured access interface, Secured access interface having Login consists of fields with proper tab order as Username (Textbox, Mandatory), Password (Textbox, Mandatory), Login (Button) etc. The fields of Secured access interface do not allow the copy and paste entries in the field box for e.g. User cannot copy and paste Username and Password. In a particularly broad sense, there are contemplated herein arrangements for accepting user identifiers for Site users wherein the login is restricted if invalid login credentials are provided, at first login the user is prompted to change password, On exceeding configured password age, on next login, User has been forced to change his/ her password, after predefined number of unsuccessful login attempts, the user account is locked. [0063] The Masters Module of the system and the method thereof of the present invention as described herewith comprise of Study, Site, Sponsor, Vendor, Partner CRO and SMO modules. The master module generates and maintains a Study Master. The study master is design to facilitate a user to view Listing of Studies, Create/Modify New Study, Define Sponsor Team, Define Karmic Team, Define CRO Team, Select Vendor & Update Vendor Contacts, Define Task Ownership Matrix, Select Sites / Investigator(s) / Support Staff / I EC, Define Procedures (Lab Procedures / Study Procedures), Define Approval Matrix, Define Study Manual (Start-up Plan, IP Plan, Comm Plan & Annexures), Define Monitoring Plan (Monitoring, Site Plan, Select Visit Schedule)
[0064] A Site Master of the master module facilitates a user to view Listing of Sites, Create/Modify New Site, Define Therapeutic Area for Area, Define Site Contact, Define EC Languages, Define Investigator, Define Support Staff, Define SMO.
[0065] A Sponsor Master of the master module facilitates a user to View Listing of Sponsor, Create/Modify New Sponsor, Define Sponsor Team. [0066] A Vendor Master of the master module facilitates a user to view Listing of Vendor, Create/Modify Vendor. [0067] A Partner CRO Master of the master module facilitates a user to view Listing of Partner CROs, Create/Modify Partner CRO, Define Partner CRO Team, Define CRO Trial Experience.
[0068] A SMO Master of the master module facilitates a user to view Listing of SMO, Create/Modify New SMO.
[0069] The CTMS Module of the system and the method thereof of the present invention as described herewith comprise of Feasibility, CPP, Budget, and Monitoring modules.
[0070] The feasibility module is responsible execute the pre - feasibility search wherein the user can use parameter search to filter site / investigator data, finalize the list by select or discard sites I investigator from list and Save the list. The Feasibility module is configured to facilitate user to View Listing of Feasibilities / Export to Excel or PDF, Create/Modify Feasibility, Select Sites, Build Site Feasibility Questionnaire (SFQ), Administer Site Feasibility Questionnaire (SFQ) to Investigators, Edit Site Response, View Final Study Feasibility Report. Base on the study variable inputs from the master module the Feasibility module selects source of search from the pre-feasibility list or site database, processes the selection by applying study weightages performance parameters to Short list sites and add feasibility scoring, Sorts based on scoring data and saves feasibility sites listing. The module processes the listing to generate Site feasibility report and also allows a use to create new feasibility report by calling in saved feasibility data. The module authorizes the user to add data for sites, to add data in certain sections of report, to save and preview report, to modify or edit report, to submit report for approval. The module sets Documents / process matrix for approval flow, obtains System approval or rejection, and on rejection cites the reason for rejection so that the User can reuse rejected feasibility report, correct and resubmit. The module processes the study site feasibility and maintains a feasibility matrix (Decision weightage criteria) thus to allow the user to have site performance parameter which in turn allows the user to set the calculation weightage (such that all weights total to 00). [0071] The Clinical Project Pla module of the CTMS module provides a user Listing of CPPs, allows the user to view CPP Dashboard (Study Specific), select CPP activities in Scope (Study Specific), Create CPP, View/Update Dynamic CPP, and manages Tollgate Migration for various Study Tollgates upon completion of milestones. The module receives user inputs such as but not limited to study information / general information, Start and End dates, key resources etc. and processes the same to create a plan wherein the plan is formed by creating the scope of the study, selecting and integrating the details from the Role and Responsibility Master, Employee team details, Sponsor team details, Vendors, Sites details and the respective Workflow Matrix. Further, based on the user defined inputs such as but not limited to study information / general information, Start and End dates, key resources etc. site Site Strategy plan has been created which is subjective visit plan. The module also establishes an IP Plan. Th module facilitates user to create Quality Assurance / Study Audit Plan by Monitoring findings and actions for each finding, Project deliverables & document plan and allows user to schedule Study Audit for Internal/ customer Deliverables and SLA. The module further facilitates the user to create Communication Plan (text template), Reporting Plan (text template) Escalation Set-up, and Risk Management Plan. The module allows the user to create Operation masters to support plan / monitor data, Create/Modify Schedule and integrate the Regulatory Plan. [0072] The Budget module of the CTMS module manage the Listing of Budget, processes the listing of budget to Add/Edit Study Budget, provides access to the Approved Budget, Tracks Budget (Study Specific). The module processes the respective budget to Add Expenses (Study Specific), View Investigator Payment / Update Investigator Payment / Investigator Payment Summary, Add Lab Procedures / Add Screening Costs / Add Study Procedure Costs and provides Budget Summary (Aggregate / Monthly).
[0073] The Monitoring module of the CTMS module manages the monitoring plan and processes the plan based on the received inputs to Update Monitoring Plan, to set Monitoring Calendar and Create Monitoring Reports (SIV/SMV/SCV Report), Review & Score Monitorin Report, Perform Monitoring QA and establish Monitoring Performance (Monitor Wise). The monitoring module monitors Site for patient recruitment, checking the investigator target and Monitor visits. The module monitors milestone and tasks, SAE activities, CRF Retrieval, Regulatory Timelines, and Essential Documents & TMF. The modules process the Project budget to enter! manage Study Expenses, enter! manage Site Expenses, create payment flow/! monthly site payment advice and thus monitors the project budget. The module also monitors the Monitoring visits and workf lows through receiving and processing all visit data submissions such as PSSV, SIV, SMV, and SCV.
[0074] The Hybrid EDC/CDMS Module of the system and the method thereof of the present invention as described herewith comprise of Study Builder, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module to capture patient trial data from polarity of patients from plurality of sites for any of the plurality of study /trial, storing the same in compatible format and making it available to the interfacing and interacting external modules for further processing.
[0075] In one another embodiment of the present invention the system modules may include Study Builder module,
[0076] As per the Study Builder module of Integrated clinical trials management system described herewith, the Study Builder module and the method thereof, may allow creation of Items, may allow user to edit/modify item for a particular visit, to remove an item for a visit. [0077] As per the Study Builder module of Integrated clinical trials management system described herewith, the Study Builder module and the method thereof, may allow creation of code lists, may allow user to add a code list to an item value, creation of CRF pages/screens^ creation of visit structure, to edit a visit structure, to remove/delete a visit structure, to configure Hard checks, to create edit checks of type mandatory (Checks to Capture blank value), to create edit checks to Range Type, to build checks for Date Verification, to configure edit cheeks for Date Comparison, to create validation checks of type Warning, also the system may allow creation and testing of derivations / calculations and may allow admin to publish trial.
[0078] In one another embodiment of the present invention the system modules may include Study Documentation module,
[0079] As per the Study Documentation module of Integrated clinical trials management system described herewith, the system may allow sponsor and CRO to upload study related documents wherein the Study documentation may be viewable to all users of the study and may allow users to download and print the study documentation. [0080] In one another embodiment of the present invention the system modules may include Electronic/Paper Data Capture & Verification Module. [0081] As per the Electronic/Paper Data Capture & Verification Module of Integrated clinical trials management system described herewith, the Electronic/Paper Data Capture & Verification Module and the method thereof, may allow enrollment of subjects, may allow data entry personnel to perform first pass data entry for enrolled subjects, to perform second pass data entry for enrolled subjects and may allow Data Manager to perform Data verification(Comparison Reconciliation) and update data to database, to enter unscheduled visits data, to upload attachments. Data Manager may only upload the documents with the following but not limited to file types such as .txt, .doc, .docx, .xls, .xlsx, .ppt, .pptx, .pdf,
[0082] As per the Electronic/Paper Data Capture & Verification Module of Integrated clinical trials management system described herewith, the Electronic/Paper Data Capture & Verification Module and the method thereof, may allow users to download attachments, may show read only audit log information for changed data, may calculate derived values, may allow investigator to navigate through visits for data entry, may allow users with print permission to print blank Case Report forms, may upload Data in CSV Formats, and may allow user to add notes and upload files for the CRF fields. [0083] In one another embodiment of the present invention the system modules may include Query Management module.
[0084] As per the Query Management module of Integrated clinical trials management system described herewith, the Query Management module and the method thereof, may auto-generate queries in batch mode, may allow Data Manager to view Query List, may allow investigator to view Query by per subject, per visit and by status and Query icon may be shown for every field in the CRF form wherein Query icon may follow the color coding scheme.
[0085] In one another embodiment of the present invention,
Integrated clinical trials management system the Query Management module and the method thereof, may allow Data Manager create DCF's for Queries, may allow monitor/Data Manager to raise queries, may allow Data Manager to resend queries and change Query status, may allow Data Manager update the Database and close queries, may show the type of the query generated wherein Query type will be "Manual" for manually raised queries and "Auto" for system generated queries and may allow exporting the Query List to PDF format. [0086] In one another embodiment of the present invention the system modules may include Medical Coding module.
[0087] As per the Medical Coding module of Integrated clinical trials management system described herewith, the Medical Coding module and the method thereof, may support standard dictionary formats including MedDRA & WHO-DD, may allow auto coding of medical terms matching with the dictionary, may allow Interactive coding of medical terms and may have an option to propagate medical coding. [0088] In one embodiment of the present invention the system modules may include Data Loader module.
[0089] As per the Data Loader module of Integrated clinical trials management system described herewith, the Data Loader module and the method thereof, may upload data in CSV Format, facilitate the user to create control file to upload the data, to verify data from the loaded data with the CRF data,
[0090] In one another embodiment of the present invention, Integrated clinical trials management system the Data Loader module and the method thereof, may generate queries for out of range and null for the loaded data and allow the user to load data in two ways, Incremental Load and / or Non - Incremental Load. The system through the module may attain functionality to validate data to be loaded, to extract uploaded data. The system through the module may prompt for user notification when load files contain data to be modified. The system through the module may generate a detailed batch report for batches being loaded with the timestamp. [0091] In one another embodiment of the present invention, the system may allow sponsor to view trial data in the form of dashboardsThe Interactive Voice / Web Response module, the Interactive Voice / Web Response module is configured to constitute any new study specific IVRS / IWRS requirements including study design, sample size, study period, treatment arms/cohorts, visit schedule, dose calculation/modification schedule, IP Plan etc. pertaining to Randomization Schedule Generation and IP Management activities for the said study. The module supports all types of study designs, randomization plans etc. used in clinical trials.
[0092] The Randomization Sub-Module of the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Provide Inputs and Generate Randomization Schedule as per the Study Protocol or Upload existing Randomization Schedule as per the Study Protocol.
[0093] The Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to create Central Depots(s) and Site Entities as well as set-up the entire Inventory Plan (Initial Inventory Assignment, Batch and Kit Set-up, Minimum Order Quantity/Re-Supply quantity and logic, Shipping & Delivery Lead Time and IP Returns/Destruction etc.) for the study using the IP Management Module.
[0094] The Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Screen and Randomize the subjects and generate unique Screening ID and Subject ID as per the defined study design and randomization schedule respectively; to allow visit confirmation and real-time assignment of kits to patients as per the defined randomization schedule; to allow site users to manually raise re-supply request, affect site-to-site IP transfer, site-to- Central Depot transfer etc.; to allow real-time, batch-wise and kit-wise tracking of Inventory status at Central Depot, Site and Subject; to allow authorized users to unblind the subject in the event of an SAE, Safety Event or as determined by the Investigator; to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process. The module is also configured for allow authorized users to generate and extract/auto-email the following reports to study team:
· Randomization Schedule
• Central Depot Inventory Tracker
• Site/Subject Inventory Tracker with Supply, Re-Supply, Return and
Destruction tracking
• Subject Visit Tracker (existing report)
· Subject Visit Confirmation Report
[0095] The Repository Module of the system and the method thereof of the present invention as described herewith allow storing and retrieval of all Study Documents in a structured manner and is comprise of Staging data store module wherein the incremental data from the source system has been extracted using reusable scripts and loaded in to the Staging data store module for further processing.
[0096] The Dashboards and report Module of the system and the method thereof of the present invention as described herewith comprise of Master Dashboards, CO Standard Reports, D Standard Reports, Departmental Trackers, and Performance Reports. Master dashboards. The Dashboards Module of the system generates and maintains Dashboards as per the user defined inputs and the study Plan configuration. Generally The module generates and maintain Dashboards for Audit Summary, Compliance Summary, Safety Summary, Medical Writing Summary, Clinical Operations SLA, Data Management SLAs, Regulatory Status Summary, Regulatory Approval Timelines, EC Status Summary, Project Phase Wise Summary, Data Management Statistics, Subject Statistics, Project Tollgate Summary. The module generates Clinical Operations Standard Reports such as but not limited to Subject Logs, Deviation Logs, IP Log, SAE Log, Regulatory Timelines, Recruitment Status, DM Standard Reports, Query Report, AE/ SAE Report, Medical Coding Report, Departmental Report. The module of the System allow authorized departmental users to view/ update the trackers such as but not limited to DM Tracker, BS Tracker, MS Tracker, QA Tracker, VOC Tracker. [0097] The module of the system generates Performance Reports by populating the entire task for which Project Team needs to be graded and allow the respective reporting manager to grade the individual team member for CO/DM/BS/MS/QA.
[0098] The Regdex Module of the system and the method thereof of the present invention as described herewith allows User to add country wise Regulatory Bodies and Regulatory Details.
[0099] In a preferred embodiment, the method comprises the steps of receiving user identification data from a plurality of users, each of th plurality of users providing input at a user interface module through a secured user access, receiving the input from the user interface module, mapping the input wit a plurality of master templates at a master unit, selectively fetching preferred master templates from the plurality of master templates, the master templates fetched based upon pre-determined rules embedded in the master unit and request from at least one of the plurality of users displaying the preferred master templates to the user at the user interface module, storing received input data from the plurality of users for the displayed preferred master templates, processing the received input to convert the received input into a compatible format, receiving the feasibility search request from the plurality of users wherein each of the plurality of users provide plurality of parameters for filtering the site, investigation data, preparing the site feasibility questionnaire based on the plurality of parameters, short list a plurality of sites, add feasibility scoring, generation feasibility matrix; Select clinical priority plan based on the plurality of user inputs, creating the scope of the study based on plurality of details fetched from the respective master, creating site strategy plan based on the study plan, creating quality assurance study audit plan, scheduling study audit for internal customer deliverables and SLA, storing country wise regulatory bodies and regulatory details, receiving inputs for the clinical trial from the user, extracting required regulatio details, further extracting masters from the master module as per the study plan based on the user inputs and the respective regulatory details, receiving study plan and respective site details at EDC/CDMS Module, capturing the patient trial data at EDC/CDMS from the study sites respective to the study plan by mapping the input with a plurality of master templates as configured in the study plan by selectively fetching the master templates from the master units, displaying the preferred master templates to the sites to capture patent trial data, storing received input data from the plurality of testing sites for the displayed preferred master templates, processing the received inputs to convert the received input into a compatible format, synchronizing the processed input data with patient / sites profile of the plurality of patient / sites to formulate synchronized data packet carrying patient trial data, updating the synchronized data at a memory unit of the data capture unit, constituting any new study specific IVRS / IWRS requirements including study design, sample size, study period, treatment arms/cohorts, visit schedule, dose calculation/modification schedule, IP Plan etc. pertaining to Randomization Schedule Generation and IP Management activities for the said study, receiving from the eTMF module the entire trial master file in an electronic format in structural folders with a directory structure as per the ICH-GCP clauses and guidelines, creating and reporting plan based on inputs from the eTMF module and study plan; creating budget plan based on the plurality of inputs such as user sponsoring defined budget inputs, updating the plurality of payment data, creating risk management plan based on plurality of parameters described through the study plan, site strategy plan, ETMF inputs, budget inputs, creating monitoring plan based on the plurality of inputs such as user defined inputs for the start and end date, budget, etc., review and compare the site master file against the electronic trial master file during monitoring visits and update and reconcile the two o the fly by updating the missing file from site master file onto the electronic trial master file or updating the missing document from electronic from master file to the site master file, transporting and updating trial master file respective to the site master file in a plurality of electronic format, storing user profiles of the plurality of users, periodically updating the received input data and generated report, generating and maintaining dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration.
[00100] A system for integral clinical trial, the system comprise of a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user, an admin module to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial; a master module, the master unit configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates, a CTMS module, the CTMS module comprising of a feasibility module, the feasibility module to generate site feasibility study and report plan, a CPP module, the CPP module to generate study plan, a Budget module, the Budget module to generate Budget plan and a Monitoring module, the Monitoring module to generate monitoring plan, a EDC/CDMS Module comprise of Study Builder, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module to capture patient trial data from polarity of patients from plurality of sites for any of the plurality of study /trial, storing the same in compatible format and making it available to the interfacing and interacting external modules for further processing, an Interactive Voice / Web Response module, the Interactive Voice / Web Response module is configured to constitute any new study specific IVRS / IWRS requirements including study design, sample size, study period, treatment arms/cohorts, visit schedule, dose calculation/modification schedule, IP Plan etc. pertaining to Randomization Schedule Generation and IP Management activities for the said study. The module supports all types of study designs, randomization plans etc. used in clinical trials, The Randomization Sub-Module of the Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Provide Inputs and Generate Randomization Schedule as per the Study Protocol or Upload existing Randomization Schedule as per the Study Protocol. The Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to create Central DepOts(s) and Site Entities as well as set-up the entire Inventory Plan (Initial Inventory Assignment, Batch and Kit Set-up, Minimum Order Quantity/Re-Supply quantity and logic, Shipping & Delivery Lead Time and IP Returns/Destruction etc.) for the study using the IP Management Module. The Interactive Voice / Web Response module of the system for integral clinical trial is configured to allow authorized users to Screen and Randomize the subjects and generate unique Screening ID and Subject ID as per the defined study design and randomization schedule respectively; to allow visit confirmation and real-time assignment of kits to patients as per the defined randomization schedule; to allow site users to manually raise re-supply request, affect site-to-site IP transfer, site-to- Central Depot transfer etc.; to allow real-time, batch-wise and kit-wise tracking of Inventory status at Central Depot, Site and Subject; to allow authorized users to unblind th subject in the event of an SAE, Safety Event or as determined by the Investigator; to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process. The module is also configured for allow authorized users to generate and extract/auto-email the reports to study team such as but not limited to Randomization Schedule, Central Depot Inventory Tracker, Site/Subject Inventory Tracker with Supply, Re- Supply, Return and Destruction tracking, Subject Visit Tracker (existing report), Subject Visit Confirmation Report, an electronic trial master module, electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format, upload the files as per the m-TMF and s-TMF requirements, automatically rename the file as per defined nomenclature and filter criteria, define the work flow and provide access rights to various folders to other study team members, review/approve or reject the uploaded files, reconcile the TMF and SMF as per their requirements, The module must not allow any users to download any files without approval and allow users to raise request for downloading any files, approve/ reject users request for downloading files, exhibiting respective dash boards, generating respective plurality of reports, a Repository module, the repository module comprising of server, the server configured for storing user profiles of the plurality of users, periodically updating the received input data and generated report, a Dashboard and report module, the Dashboard and report module to generate and maintain dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration, a Regdex module, the Regdex module to store country wise regulatory bodies and regulatory details.. [00101] The system for integral clinical trial, the system comprise of a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user, The user interface module comprise of user I/O module for receiving inputs from the user and user authentication module wherein the user authentication module receives input from the user I/O module, fetches the identification details from the administration module and provide secured access when user inputs results in to valid inputs. For invalid entries the module prompts user for the predefined times and then locks the user account.
[00102] The administration module is a control unit which configures the system and controls overall operation of the systems to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial;
[00103] The master module, the master unit configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates. The master unit comprise of Lookup stacks for storing master templates and LUS configuration and extraction logic to configure and extract the master templates in accordance to the requirement.
[00104] The CTMS module, the CTMS module comprising of a feasibility module, the feasibility module to generate site feasibility study and report plan, a CPP module, the CPP module to generate study plan, a Budget module, the Budget module to generate Budget plan and a Monitoring module, the Monitoring module to generate monitoring plan and synchronization unit to control and synchronize the functioning of the CTMS module. The feasibility module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub- masters , constituting the Master. The CPP module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master. The Budget module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data— master mapping and integration logic to map the data to the respective sub- masters , constituting the Master. The Monitoring module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.
[00105] The EDC/CDMS Module of the system and the method thereof of the present invention as described herewith comprise of Study Builder, Electronic/Paper Data Captur & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module. The EDC/CDMS Module is comprise of a communication module configured for receiving data input from the site; a memory unit configured for storing and updating the received input at the Electronic/Paper Hybrid Data Management unit; a processor comprising Study Builder module, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module configured for processing the received input to convert the received input into a format compatible with the Electronic/Paper Hybrid Data Management unit, processing further to maintain and update the data at the memory in compatible format to that of the other interacting modules; and a synchronization unit configured for synchronizing the processed input data with user profiles of the plurality of users to formulate the synchronised data packet carrying user defined data.
[00106] The Interactive Voice / Web Response module, the Interactive Voice / Web Response module comprising of voice and data communication module and a display module constituting user input - output interface, memory constituting the database to store, maintain and update study specific IVRS / IWRS requirements and Randomization Sub- Module processor for processing the input received to create Central Depots(s) and Site Entities as well as set-up the entire Inventory Plan for the study pertaining to Randomization Schedule Generation and IP Management activities for the said study to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process. The module supports all types of study designs, randomization plans etc. used in clinical trials. [00107] The electronic trial master module, the electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format. The electronic trial master module comprise of optical reader interface to capture data and communication module to communicate to the site. [00108] The Repository module, the repository module comprising of server, the server configured for storing user profiles of the plurality of users, periodically updating the received input data and generated report;
[00109] A Dashboard and report module, the Dashboard and report module to generate and maintain dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration. The Dashboard and report module comprise of lookup stacks to store the dashboard and report templates and the final generated dashboard and reports.
[00110] The Regdex module, the Regdex module comprise of a database to store country wise regulatory bodies and regulatory details.
[00111] The present invention may overcome the challenges of the current scenario of use of for variety of applications typically used in the clinical trial management, through single interface as depicted in the description of the present invention.
[00112] Advantages of present invention may be listed as:
· Single integrated system with all key features and functionalities required for managing end-to-end clinical projects combined into one.
• Single Data Repository to access enterprise wide Clinical and
Operational data as well as Masters from a single, clean data source.
• Ease of usage for project and supervisory staff in planning, managing, budgeting, tracking and reporting all ongoing project activities.
• Advanced performance reporting, dashboards and operational analytics to enable Senior Management to get an integrated enterprise wide view of all operational metrics and determine health of operations as well as take the necessary corrective action.
• Easily capture electronic data from sites for ongoing studies and link it to real-time performance reviewing and reporting.
• Provide Electronic Trial Master File archiving and online auditing functionality to customers and regulators across the globe with the click of a mouse. Create SDTM compliant datasets for submission to regulatory bodies in desired data format.
Low total cost of ownership of system.
Modular structure for rapid new module and functionality enhancement. These include:
Integrated Voice Recognition System (IVRS) / Integrated Web Recognition System (IWRS) for IP Inventory Management, Subject Allocation, Reconciliation and Tracking in randomized, blinded trials, In-Built Safety Database for logging, tracking and regulatory reporting of Adverse and Serious Adverse Events (AE/SAE), Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experiences Report (PADER) as per USFDA, EMA and Local Regulatory Requirements for clinical trials as well as marketed drugs. Customized Performance Reporting Dashboards and Drill-down Operational Analytics, Unified Clinical, Operational Masters and Staging Data Repository.

Claims

Claims :
A method of integral clinical trial system comprising the steps of: receiving user identification inputs;
authenticating the user for secured access;
profiling each unique user through analyzing and processing data;
capturing and storing user defined inputs on various user platforms;
generating and maintaining the study masters;
generating and maintaining the site masters- generating and maintaining the sponsor masters;
generating and maintaining the vendor masters;
generating and maintaining the Partner CRO masters;
generating and maintaining the SMO masters;
extracting and searching the electronic trial master file based on the user input defining the test from the masters;
creating pre-feasibility search to finalize the site investigator list;
building and administering the site study feasibility to obtain final study feasibility report; creating clinical project plan by selecting clinical project activities in scope from listing of clinical project plans;
creating site strategy and visit plan;
creating IP plan;
creating QA and study audit plan;
creating communication plan;
creating escalation setup;
creating role management plan;
creating and managing budget;
creating monitoring plan for monitoring site;
capturing the patient trial data from the study sites respective to the study plan
storing received input data from the plurality of testing sites synchronizing the processed input data with patient / sites profile of the plurality of patient / sites to formulate synchronized data packet carrying patient trial data
constituting any new study specific IVRS / IWRS requirements transmitting the entire trial master file in an electronic format in structural folders with a directory structure for updating the missing document from electronic from master file to the site master file monitoring project budget;
reporting plan decision;
reporting budget decision;
reporting portfolio or tracer view;
maintaining the repository for storing and management of study documents; and
creating, maintaining and establishing the dashboards for various reports.
2. The method as claimed in claim 1 wherein the user identification inputs are received through the user interface terminals.
3. The method as claimed in the claim 1 , wherein the authentication of the user for secured access is through user interface module.
4. The method as claimed in the claim 1 wherein the administrator module is configured for profiling each unique user.
5. The method as claimed in the claim 1 wherein the step of generating and maintaining study master comprising steps of constituting and integrating various sub masters such as listing of studies, Define Sponsor Team, Define Karmic Team, Define CRO Team, Select Vendor & Update Vendor Contacts, Define Task Ownership Matrix, Select Sites / Investigators) / Support Staff / IEC, Define Procedures (Lab Procedures / Study Procedures), Define Approval Matrix, Define Study Manual (Start-up Plan, IP Plan, Comm Plan & Annexures), Define Monitoring Plan (Monitoring, Site Plan, Select Visit Schedule)
6. The method as claimed in the claim 1 , wherein the extraction of the electronic trial master file based on the user inputs defining the test is through electronic trial master file module.
7. The method as claimed in the claiml wherein the step of generating and maintaining site master comprising steps of constituting and integrating various sub masters such as Listing of Sites, Define Therapeutic Area for Area, Define Site Contact, Define EC Languages, Define Investigator, Define Support Staff, Define SMO.
8. The method as claimed in the claiml wherein the method comprising steps of receiving user identification data from a plurality of users, each of the plurality of users providing input at a user interface module through a secured user access, receiving the input from the user interface module, mapping the input with a plurality of master templates at a master unit, selectively fetching preferred master templates from the plurality of master templates, the master templates fetched based upon pre-determined rules embedded in the master unit and request from at least one of the plurality of users displaying the preferred master templates to the user at the user interface module, storing received input data from the plurality of users for the displayed preferred master templates, processing the received input to convert the received input into a compatible format, receiving the feasibility search request from the plurality of users wherein each of the plurality of users provide plurality of parameters for filtering the site, investigation data, preparing the site feasibility questionnaire based on the plurality of parameters, short list a plurality of sites, add feasibility scoring, generation feasibility matrix; Select clinical priority plan based on the plurality of user inputs, creating the scope of the study based on plurality of details fetched from the respective master, creating site strategy plan based on the study plan, creating quality assurance study audit plan, scheduling study audit for internal customer deliverables and SLA, storing country wise regulatory bodies and regulatory details, receiving inputs for the clinical trial from the user, extracting required regulation details, further extracting masters from the master module as per the study plan based on the user inputs and the respective regulatory details, receiving study plan and respective site details at EDC/CDMS Module, capturing the patient trial data at EDC/CDMS from the study sites respective to the study plan by mapping the input with a plurality of master templates as configured in the study plan by selectively fetching the master templates from the master units, displaying the preferred master templates to the sites to capture patent trial data, storing received input data from the plurality of testing sites for the displayed preferred master templates, processing the received inputs to convert the received input into a compatible format, synchronizing the processed input data with patient / sites profile of the plurality of patient / sites to formulate synchronized data packet carrying patient trial data, updating the synchronized data at a memory unit of the data capture unit, constituting any new study specific IVRS / IWRS requirements including study design, sample size, study period, treatment arms/cohorts, visit schedule, dose calculation/modification schedule, IP Plan etc. pertaining to Randomization Schedule Generation and IP Management activities for the said study, receiving from the eTMF module the entire trial master file in an electronic format in structural folders with a directory structure as per the ICH-GCP clauses and guidelines, creating and reporting plan based on inputs from the eTMF module and study plan; creating budget plan based on the plurality of inputs such as user sponsoring defined budget inputs, updating the plurality of payment data, creating risk management plan based on plurality of parameters described through the study plan, site strategy plan, ETMF inputs, budget inputs, creating monitoring plan based on the plurality of inputs such as user defined inputs for the start and end date, budget, etc, review and compare the site master file against the electronic trial master file during monitoring visits and update and reconcile the two on the fly by updating the missing file from site master file onto the electronic trial master file or updating the missing document from electronic from master file to the site master file, transporting and updating trial master file respective to the site master file in a plurality of electronic format, storing user profiles of the plurality of users, periodically updating the received input data and generated report, generating and maintaining dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration.
9. The method as claimed in the claim 8 wherein the steps of capturing the patient trial data frqm the study sites respective to the study plan comprising step of mapping the input with a plurality of master templates as configured in the study plan by selectively fetching the master templates from the master units, displaying the preferred master templates to the sites to capture patent trial data, Storing received input data from the plurality of testing sites for the displayed preferred master templates, processing the received inputs to convert the received input into a compatible format, synchronizing the processed input data with patient / sites profile of the plurality of patient / sites to formulate synchronized data packet carrying patient trial data, updating the synchronized data at a memory unit of the data capture unit.
10. The method as claimed in the claim 1 and claim 8 wherein the step of constituting any new study specific IVRS / IWRS requirements pertaining to Randomization Schedule Generation and IP Management activities comprising steps of processing the input received to create Central Depots(s) and Site Entities, set-up the entire Inventory Plan for the study pertaining to Randomization Schedule Generation and set-up the entire Inventory Plan for the study pertaining to IP Management activities for the said study, provide access of Randomization Schedule, IP Management activities to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process. 1. A system for integral clinical trial, the system comprising:
a user interface module, the user interface module configured for receiving user identification data for identification of plurality of users and authenticating secured access to the user; an admin module, the admin module configured to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial; a master module, the master unit configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates; a CTMS module, the CTMS module comprising of
a feasibility module, the feasibility module to generate site feasibility study and report plan;
a CPP module, the CPP module to generate study plan; a Budget module, the Budget module to generate Budget plan;
a Monitoring module, the Monitoring module to generate monitoring plan; and
a synchronisation unit to control and synchronise the functioning of the CTMS module.
The EDC/CDMS Module comprising of a communication module configured for receiving data input from the site; a memory unit configured for storing and updating the received input at the Electronic/Paper Hybrid Data Management unit; a processor comprising Study Builder module, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, Quality Check, DB Lock, SDTM Mapper, and Data Extraction module an Interactive Voice / Web Response module, the Interactive Voice / Web Response module comprising of voice and data communication module and a display module constituting user input -output interface, memory constituting the database to store, maintain and update study specific IVRS / IWRS requirements and Randomization
Sub-Module processor an electronic trial master module, electronic trial master module configured for transporting and updating trial master file respective to the site master file in a plurality of electronic format. a Repository module, the repository module comprising of server, the server configured for storing user profiles of the plurality of users, periodically updating the received input dat and generated report; a Dashboard and report module, the Dashboard and report module to generate and maintain dashboards as per the user defined inputs and the study plan configuration and report generation as per the study plan configuration; and a Regdex module, the Regdex module to store country wise regulatory bodies and regulatory details;
12. The system according to claim 11 wherein the user interface module comprise of user I/O module for receiving inputs from the user and user authentication module wherein the user authentication module receives input from the user I/O module, fetches the identification details from the administration module and provide secured access when user inputs results in to valid inputs. For invalid entries the module prompts user for the predefined times and then locks the user account.
13. The system according to claim 11 wherein the administration module configures the system and controls overall operation of the systems to create roles, to assign permissions to roles, to manage features based on roles, to manage actions based on roles, to configure menu items, create a new trial/study wherein Trial Name and unique protocol id may be mandatory parameters for every trial.
14. The system according to claim 11 wherein the master Module comprise of Lookup stacks for storing master templates and LUS configuration and extraction logic to configure and extract the master templates in accordance to the requirement.
15. The master module of the system as claimed in the claim 11 , wherein the master module is configured for allotting at least one of a plurality of master templates to each of the plurality of users and mapping the received input data with a plurality of master templates.
16. The system according to claim 11 wherein the feasibility module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.
17. The system according to claim 11 wherein the CPP module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters . constituting the Master.
18. The system according to claim 11 wherein the Budget module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.
19. The system according to claim 11 wherein the Monitoring module of the CTMS module comprise of an input extraction module to extract the respective user input and the sub-masters, LUS to store the extracted sub-master and the integrated data master; and data - master mapping and integration logic to map the data to the respective sub-masters , constituting the Master.
20. The system as claimed in the claim 11 wherein EDC/CDMS Module is comprising of a communication module configured for receiving data input from the site; a memory unit configured for storing and updating the received input at the Electronic/Paper Hybrid Data Management unit; a processor comprising Study Builder module, Electronic/Paper Data Capture & Verification Module, Query management module, Medical Coding module, Data Loader module, - Quality Check, DB Lock, SDTM Mapper, and Data Extraction module configured for processing the received input to convert the received input into a format compatible with the Electronic/Paper Hybrid Data Management unit, processing further to maintain and update the data at the memory in compatible format to that of the other interacting modules; and a synchronization unit configured for synchronizing the processed input data with user profiles of the plurality of users to formulate the synchronized data packet carryin user defined data.
21. The system as claimed in the claim 11, wherein the Interactive Voice / Web Response module comprising of voice and data communication module and a display module constituting user input -output interface, memory constituting the database to store, maintain and update study specific IVRS / IWRS requirements and Randomization Sub-Module processor configured for processing the input received to create Central Depots(s) and Site Entities as well as set-up the entire Inventory Plan for the study pertaining to Randomization Schedule Generation and IP Management activities for the said study to allow authorized users to review and approve respective plans, logs and schedules at each step of the randomization and IP management process.
22. The system according to claim 11 wherein the electronic trial master module comprise of optical reader interface to capture data and communication module to communicate to the site.
23. The system according to claim 11 wherein the Dashboard and report module comprise of lookup stacks to store the dashboard and report templates and the final generated dashboard and reports.
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