CN109817290A - One clinical trial phase management system and management method - Google Patents
One clinical trial phase management system and management method Download PDFInfo
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- 238000007726 management method Methods 0.000 title claims abstract description 228
- 238000012360 testing method Methods 0.000 claims abstract description 203
- 238000013523 data management Methods 0.000 claims abstract description 36
- 238000011160 research Methods 0.000 claims abstract description 13
- 238000012216 screening Methods 0.000 claims abstract description 11
- 239000003814 drug Substances 0.000 claims description 40
- 238000000034 method Methods 0.000 claims description 37
- 230000008569 process Effects 0.000 claims description 33
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- 239000000126 substance Substances 0.000 claims description 22
- 229940079593 drug Drugs 0.000 claims description 21
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- 238000009472 formulation Methods 0.000 claims description 16
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- 238000012552 review Methods 0.000 claims description 16
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Abstract
The present invention provides a clinical trial phase management system and management methods, it is related to clinical testing data supervision and management technical field, including work station subsystem, subject data management subsystem, I phase experimental study room management subsystem, pilot project management subsystem and Ethics Committee evaluate subsystem.The technical solution carries out data with each functional subsystem respectively by using work station subsystem and docks, data management structure and data file interactive mode are had adjusted for Phase I clinical trial feature, clinical test project is combined with subject data and research department's management respectively, realize the application approval of clinical test project, the equipment use and personal scheduling and the screening of clinical test subject of clinical experimental study room, notice and data save, and then realize the unification dynamic information system management online of Phase I clinical trial, alleviate the technical problem of Phase I clinical trial information system management difficulty of the existing technology.
Description
Technical field
The present invention relates to clinical testing data supervision and management technical fields, more particularly, to an a kind of clinical trial phase management
System and management method.
Background technique
Since China implements from " drug clinical trial quality management practices " (Good Clinical Practice, GCP),
The aggregate level and ability to supervise of clinical drug trial have a very big promotion, but the I phase tests and international most advanced level is there are also gap,
Urgently to be speculated and raising., there is very big uncertainty in Phase I clinical trial, especially human trial for the first time, risk is higher, and
Its subject is mostly healthy population.To guarantee that Phase I clinical trial real result is reliable, Phase I clinical trial quality management is adapted to
It needs, protects subjects interest and safety, need the management system for being suitble to Phase I clinical trial laboratory feature.
Secondly, in recent years in order to meet the needs of new drug development fast development, China's new medicine research and development amount of declaring increases year by year
Add.Phase I clinical trial, especially new medicine and imitation medicine Phase I clinical trial quantity rapid growth, test China I phase total
Ability of immigrants and management level are put forward higher requirements.For drug I phase experimental design and the complexity of implementation and innovative, formulation
Corresponding guideline, to improve the science of I phase experimental design, the reasonability of ethics, the normalization of implementation, guidance new drug is ground
Hair develops rapidly and healthily.In China, medicament research and development reaches under international requirement, under the background of new drug development globalization, is
China's medicament research and development is set to move towards higher level, it is necessary to be directed to Phase I clinical trial feature, formulate special management system, and show
On some clinical test lines management system be difficult to be managed according to Phase I clinical trial feature structure and data file interaction into
Row adjustment, to sum up, there are the technical problems of Phase I clinical trial information system management difficulty for the prior art.
Summary of the invention
In view of this, the purpose of the present invention is to provide a clinical trial phase management system and management method, it is existing to alleviate
Difficult technical problem is queried with the presence of checking on the line of technology clinical testing data.
In a first aspect, the embodiment of the invention provides an a kind of clinical trial phase management system, including work station subsystem,
Subject data management subsystem, I phase experimental study room management subsystem, pilot project management subsystem and Ethics Committee are commented
Examine subsystem；Wherein, work station subsystem respectively with subject data management subsystem, I phase experimental study room management subsystem
Bi-directional data connection is carried out between pilot project management subsystem；Pilot project management subsystem and Ethics Committee's evaluation
System connection；
The input terminal of pilot project management subsystem receives the project application of sponsor, and carries out the typing of the contents of a project, submits
The contents of a project to Ethics Committee's evaluation subsystem carries out Ethic review, and receives the Ethic review of feedback as a result, the project of generation
The project data information of generation is sent respectively to sponsor and is recruited object by data information；
The input terminal of I phase experimental study room management subsystem obtains project data information by work station subsystem, and according to item
Mesh data information chooses researcher, is simultaneously emitted by Item announcements to the researcher chosen；The phase experimental study room I manages subsystem
System also generates and output test facility information and test site information, and by project initiation situation and arranges to carry out with document form
It saves into document formulation and preserving module；
The input terminal of subject data management subsystem acquires the physique and physics and chemistry for being recruited subject transmitted by testing equipment
It checks data, and the selected subject for participating in clinical test of integration project data information, records the clinical testing data of subject,
Generate the case report form and doctor's advice report of subject；
The station subsystem that works receives the project data information that pilot project management subsystem is sent, and is generated according to project data information
Project item；It is set also according to received user and generates user's setting item, and project item and user are set into item and sent
To its corresponding terminal；And record in real time is carried out to generation, the circulation of data, file before and after clinical test process and is protected
It deposits, and will save and the data of record, file shows.
Further, in clinical trial phase management system provided in an embodiment of the present invention, subject data manages subsystem
System includes that subject enters a group data cell, checks data cell, test data unit, case report form generation unit and doctor's advice report
Accuse generation unit；
Subject enters group data cell and is generated and its unique corresponding identity item according to the essential information for being recruited subject's submission
Shape code；Check that data cell is made of physical data module and physico-chemical examination data module, for tested to being recruited
Person carries out a medical examination with physico-chemical examination and generation is recruited the inspection result data of subject；Inspection result data includes physique
Check data and physico-chemical examination data；Subject enters group data cell and obtains inspection result data, and the data are compared
Screening, selection is satisfactory to be recruited subject as subject, and the selection result is sent to and is recruited subject, simultaneously
The attribute for being recruited subject is labeled as passing through into group；
Doctor's advice report generation unit generates doctor's advice report according to inspection result data；
Test data unit includes hospitalization data management module, administration data management module, blood sampling data management module, observed number
According to management module and adverse events generate and reminding module, for tracking the clinical test process of subject and recording clinical test
Data；
Case report form generation unit is corresponding with the ID bar code of subject according to clinical testing data and doctor's advice report generation
Case report form (Case Report Form, abbreviation CRF).
Further, in clinical trial phase management system provided in an embodiment of the present invention, work station subsystem includes
Database Unit and system transaction management unit connected to it, user is entreated to set transaction management unit and display unit；
System transaction management unit between central database unit and pilot project management subsystem by connecting, for according to item
The project data information that mesh management subsystem is sent generates project item, and project item is according to the project in project data information
The prompting item of node creation, and project item is sent to display unit progress item and is shown；
User sets transaction management unit and also receives user's setting that researcher is submitted by user terminal, and is set according to user
Fixed and project data information generates user and sets item, and user's setting item is sent to display unit progress item and is shown；
Central database unit also connect with subject data management subsystem and I phase experimental study room management subsystem real respectively
Existing data interaction.
Further, in clinical trial phase management system provided in an embodiment of the present invention, system transaction management unit packet
It includes work calendaring module and project process logging modle connected to it, outstanding work reminding module and critical event reminds mould
Block；
Project process logging modle, outstanding work reminding module and critical event reminding module also manage son with pilot project respectively
System connection；
Project process logging modle is used to generate project process item according to project data information；Outstanding work reminding module and again
Want event reminding module for generating project process item according to project data information；Critical event reminding module is used for according to item
Mesh data information generates project process item.
Further, in clinical trial phase management system provided in an embodiment of the present invention, the management of the phase experimental study room I
Subsystem include testing crew information management module, test site management module, testing equipment management module and document formulate and
Preserving module, I phase experimental study room management subsystem generate and issue Item announcements and information to clinical test related personnel；
Testing crew information management module is believed according to project data information, by the matched mode of key data in testing crew
Researcher is chosen in breath management module, and researcher's information of selection is carried out in real time in document formulation and preserving module
Record saves；
Testing equipment management module generates testing equipment information according to project data information configuration testing equipment, and test is set
Standby information carries out record in real time in document formulation and preserving module and saves；
Test site management module chooses test site according to project data information, generates test site information, and by test site
Ground information carries out record in real time in document formulation and preserving module and saves.
Further, in clinical trial phase management system provided in an embodiment of the present invention, pilot project management subsystem
Including project release module, drug maintenance module and subject recruitment information issuing module；
Project release module instructs publication item related information according to the publication of sponsor, and item related information is sent to human relations
The reason committee evaluates the assessment that subsystem carries out ethics to project and audits；
Drug maintenance module extracts clinical medicine information according to item related information and is deposited into drug maintenance module；
Subject recruitment information issuing module is used for after project release module issues item related information, and arrangement is able to bear
The every of the subject of the project clinical test checks data standard, issues clinical test subject recruitment information.
Second aspect, the embodiment of the invention provides an a kind of clinical trial phase management methods, comprising the following steps:
(1) input terminal of pilot project management subsystem receives the project application of sponsor, and carries out the typing of the contents of a project, together
When submit the contents of a project to Ethics Committee evaluation subsystem carry out moral check examination；
(2) Ethics Committee's evaluation subsystem carries out Ethic review, and Ethic review result is fed back to pilot project management subsystem
System, if evaluation passes through, pilot project management subsystem generates item number it is believed that ceasing, and carry out item related information publication；
(3) input terminal of I phase experimental study room management subsystem obtains project data information by work station subsystem, generates simultaneously
The information of output test facility information and test site, and by project initiation situation and arrange to save with document form to text
In shelves formulation and preserving module；And researcher is chosen according to project data information, while issuing to the researcher of selection
Item announcements notify it to prepare clinical test；
(4) after item related information publication, the drug maintenance module of pilot project management subsystem is mentioned according to item related information
It takes clinical medicine information and is deposited into drug maintenance module, subject recruitment information issuing module combination clinical medicine letter
Breath and project data information arrange the every of the subject for being able to bear the project clinical test and check data standard, and by by
Examination person recruits information issuing module and issues clinical test subject recruitment information；
(5) subject enters group data cell and is generated and its unique corresponding identity according to the essential information for being recruited subject's submission
Bar code checks that data cell carries out a medical examination and physico-chemical examination to being recruited subject, and generates and be recruited subject's
Inspection result data；Subject enters a group data cell and obtains and save inspection result data, and screening, root is compared to the data
According to check data standard choose it is satisfactory be recruited subject as subject, and the selection result is sent to be recruited by
Examination person notifies subject to prepare to participate in clinical test, while the attribute for being recruited subject being labeled as passing through into group；
(6) after subject handles the staying-in-hospital procedures of clinical test, by doctor's advice report generation unit according to the physique of subject
It checks and the inspection result data of physico-chemical examination generates doctor's advice report, be sent to test data unit, while being sent to research people
Member verifies and confirms with clinician；
(7) enter the real-time observation stage of clinical test, test data unit tracks clinical test process to subject and records
Clinical testing data updates the real-time record of result progress of being hospitalized and observe of subject, while generating and recording clinical test number
According to statistical report form or statistical report and store；
(8) case report form generation unit is according to clinical testing data and the ID bar code pair of doctor's advice report generation and subject
The case report form answered.
Further, in clinical trial phase management method provided in an embodiment of the present invention, in step (3), the I phase is tested
Research department's management subsystem generates and the information of output test facility information and test site, specifically:
Testing crew information management module is believed according to project data information, by the matched mode of key data in testing crew
Researcher is chosen in breath management module；Testing equipment management module generates examination according to project data information configuration testing equipment
Test facility information；Test site management module chooses test site according to project data information, generates test site information.
Further, in clinical trial phase management method provided in an embodiment of the present invention, further includes:
(9) project data that the system transaction management unit in work station subsystem will be sent according to pilot project management subsystem
Information generates project item, and project item includes work calendar, project process record and outstanding work, and to outstanding work and
Critical event is reminded；User sets transaction management unit reception researcher and passes through user terminal according to the development of projects situation
Work plan, memorandum, meeting schedule and the reminded contents of reservation of typing generate user and set item.
Further, in clinical trial phase management method provided in an embodiment of the present invention, further includes:
(10) central database unit in work station subsystem carries out generation, the circulation of data, file in abovementioned steps
Record saves in real time, and will save and the data of record, file shows.
The embodiment of the present invention brings following the utility model has the advantages that a clinical trial phase management system provided by the embodiment of the present invention
System and management method, including work station subsystem, subject data management subsystem, I phase experimental study room management subsystem, examination
Test project management subsystem and Ethics Committee's evaluation subsystem；Wherein, work station subsystem respectively with subject data management
Bi-directional data connection is carried out between subsystem, I phase experimental study room management subsystem and pilot project management subsystem；Test item
Mesh management subsystem is connect with Ethics Committee's evaluation subsystem.The technical solution by using work station subsystem respectively and respectively
A functional subsystem carries out data docking, has adjusted data management structure for Phase I clinical trial feature and data file is handed over
Clinical test project is combined with subject data and research department's management respectively, realizes clinical test project by mutual mode
Application approval, the equipment use of clinical experimental study room and personal scheduling and the screening of clinical test subject, notice sum number
According to preservation, and then the unification dynamic information system management online of Phase I clinical trial is realized, improves clinical trial management effect
Rate, meanwhile, which provides item for manager and reminds, and further improves user experience, improves the efficiency of management, alleviates
The technical problem of Phase I clinical trial information system management difficulty of the existing technology.
To enable the above objects, features and advantages of the present invention to be clearer and more comprehensible, preferred embodiment is cited below particularly, and cooperate
Appended attached drawing, is described in detail below.
Detailed description of the invention
It, below will be to specific in order to illustrate more clearly of the specific embodiment of the invention or technical solution in the prior art
Embodiment or attached drawing needed to be used in the description of the prior art are briefly described.
Fig. 1 is the structural schematic diagram of clinical trial phase management system provided in an embodiment of the present invention；
Fig. 2 is the structure of subject data management subsystem in clinical trial phase management system provided in an embodiment of the present invention
Schematic diagram；
Fig. 3 is the structural schematic diagram for the station subsystem that works in clinical trial phase management system provided in an embodiment of the present invention；
Fig. 4 is the knot of I phase experimental study room management subsystem in clinical trial phase management system provided in an embodiment of the present invention
Structure schematic diagram；
Fig. 5 is in clinical trial phase management system provided in an embodiment of the present invention, and the structure of pilot project management subsystem is shown
It is intended to；
Fig. 6 is the flow chart of clinical trial phase management method provided in an embodiment of the present invention.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with attached drawing to the present invention
Technical solution be clearly and completely described, based on the embodiments of the present invention, those of ordinary skill in the art are not doing
Every other embodiment obtained under the premise of creative work out, shall fall within the protection scope of the present invention.
, there is very big uncertainty in Phase I clinical trial, especially human trial for the first time, risk is higher, and its subject
Mostly healthy population.To guarantee that Phase I clinical trial real result is reliable, the needs of Phase I clinical trial quality management, protection are adapted to
Subjects interest and safety need the management system for being suitble to Phase I clinical trial laboratory feature.Secondly, in recent years in order to meet
The needs of new drug development fast development, China's new medicine research and development amount of declaring increases year by year, and manages on existing clinical test line
System is difficult to be managed structure according to Phase I clinical trial feature and data file interaction is adjusted, and is based on this, the present invention
The clinical trial phase management system and management method that embodiment provides, may be implemented Phase I clinical trial information system management, improve
Clinical trial management efficiency, compensates for the blank of the prior art, by means of the management system of database technology, assists phase real
Room and ward is tested to carry out the Data Integration in clinical test project management and the project implementation process and share.
Embodiment one:
Referring to Fig. 1, the structural schematic diagram of clinical trial phase management system provided in an embodiment of the present invention.The embodiment of the present invention mentions
The clinical trial phase management system supplied, including work station subsystem, subject data management subsystem, I phase experimental study room
Management subsystem, pilot project management subsystem and Ethics Committee evaluate subsystem；Wherein, work station subsystem respectively with by
Two-way number is carried out between examination person's data administration subsystem, I phase experimental study room management subsystem and pilot project management subsystem
According to connection；Pilot project management subsystem is connect with Ethics Committee's evaluation subsystem.
The input terminal of pilot project management subsystem receives the project application of sponsor, and carries out the typing of the contents of a project,
It submits the contents of a project to Ethics Committee's evaluation subsystem to carry out Ethic review, and receives the Ethic review of feedback as a result, generating
The project data information of generation is sent respectively to sponsor and is recruited object by project data information.
The input terminal of I phase experimental study room management subsystem obtains project data information, and root by work station subsystem
Researcher is chosen according to project data information, is simultaneously emitted by Item announcements to the researcher chosen；The phase experimental study room I pipe
Reason subsystem also generates and output test facility information and test site information, and by project initiation situation and arranges with document shape
Formula is saved into document formulation and preserving module.
The physique for being recruited subject that the input terminal acquisition of subject data management subsystem is transmitted by testing equipment and
Physico-chemical examination data, and the selected subject for participating in clinical test of integration project data information, record the clinical test of subject
Data generate the case report form and doctor's advice report of subject.
The station subsystem that works receives the project data information that pilot project management subsystem is sent, according to project data information
Generation project item；It is set also according to received user and generates user's setting item, and project item and user are set into item
It is sent to its corresponding terminal；And generation, the circulation of data, file before and after clinical test process are remembered in real time
Record saves, and will save and the data of record, file shows.
Further, referring to fig. 2, in clinical trial phase management system provided in an embodiment of the present invention, subject data
The structural schematic diagram of management subsystem.In clinical trial phase management system provided in an embodiment of the present invention, subject data pipe
Reason subsystem include subject enter a group data cell, check data cell, test data unit, case report form generation unit and
Doctor's advice report generation unit.
Subject enters group data cell and is generated and its unique corresponding body according to the essential information for being recruited subject's submission
Part bar code, is sent to inspection data cell for this ID bar code, and identification when physical examination is executed for subject；
Check data cell be to be made of physical data module and physico-chemical examination data module, for be recruited subject carry out
Physical examination and physico-chemical examination simultaneously generate the inspection result data for being recruited subject, wherein inspection result data includes physique
Check data and physico-chemical examination data；Subject enters group data cell and obtains inspection result data, and by the data in preset
Screening is compared in the normal data of standard value range and the related drugs in project data information, chooses satisfactory quilt
Subjects recruitment enters group as subject, and the selection result is sent to and is recruited subject, while this is recruited subject
Attribute be labeled as passing through into group, enter after group passes through, into the implementation phase of clinical test；Specifically, physical examination includes such as
Age of subjects recruitment, weight (or BMI), is included in a series of/judgment criterias such as exclusion criteria at height；It is recruited subject
Enter the physico-chemical examination of next step after physical examination is qualified, otherwise enters screening and exclude table；After physico-chemical examination is qualified, be recruited by
Examination person can just enter group.
Doctor's advice report generation unit generates doctor's advice report according to inspection result data, wherein inspection result data includes body
Lattice check data and physico-chemical examination data, and in clinical test implementation phase, subject should be according to doctor's advice report executing clinical test
Process.Test data unit includes hospitalization data management module, administration data management module, blood sampling data management module, observation
Data management module and adverse events generation and reminding module, for tracking the implementation process and record of the clinical test of subject
Clinical testing data；Administration data management module is administered operation to subject according to pre-designed scheme, time point,
Data are automatically associated in case report form (Case Report Form, abbreviation CRF).Data management module take a blood sample according in advance
Designed time point, data were automatically associated in CRF to subject's blood was collected operation.Data management module is observed in clinic
The real-time observation stage of test, the module observe the case where subject takes drugs front and back in real time, and main includes the mind of subject
The status tracking of inspection through system, digestive system, bleeding and adverse events, and, subject's temperature pulse respiration is shunk
The vital sign of pressure carries out record in real time to above-mentioned data and updates, and generates statistical report form or the report of record clinical testing data
And it stores.Case report form generation unit is according to clinical testing data and the ID bar code pair of doctor's advice report generation and subject
The case report form answered.
Further, referring to Fig. 3, in clinical trial phase management system provided in an embodiment of the present invention, workbench subsystem
The structural schematic diagram of system.In clinical trial phase management system provided in an embodiment of the present invention, work station subsystem includes center
Database Unit and system transaction management unit connected to it, user set transaction management unit and display unit.System thing
Item administrative unit between central database unit and pilot project management subsystem by connecting, for according to project management subsystem
The project data information that system is sent generates project item, and project item is according to the item nodes creation in project data information
Item is reminded, and project item is sent to display unit progress item and is shown；Pending item, generation such as in workflow
Serious adverse events are held notice of meeting, notice of meeting of project initiation meeting of project preparation meeting etc. and are reminded.User sets item
Administrative unit also receives researcher and is set by the user that user terminal is submitted, and according to user's setting and project data information
It generates user and sets item, and user's setting item is sent to display unit progress item and is shown；Such as set work plan, standby
Forget, meeting schedule, the reminded contents such as reservation.Central database unit is also tried with subject data management subsystem and I phase respectively
It tests the connection of research department's management subsystem and realizes data interaction, the subject's related data and research department in Query Subsystem manage phase
Data are closed, user's setting is formulated according to related data.
Further, in clinical trial phase management system provided in an embodiment of the present invention, system transaction management unit packet
It includes work calendaring module and project process logging modle connected to it, outstanding work reminding module and critical event reminds mould
Block.Project process logging modle, outstanding work reminding module and critical event reminding module also manage son with pilot project respectively
System connection.Project process logging modle is used to generate project process item according to project data information；Outstanding work reminds mould
Block and critical event reminding module are used to generate project process item according to project data information；Critical event reminding module is used for
Project process item is generated according to project data information.
Further, referring to fig. 4, in clinical trial phase management system provided in an embodiment of the present invention, the experimental study of I phase
The structural schematic diagram of room management subsystem.In clinical trial phase management system provided in an embodiment of the present invention, I phase experimental study
Room management subsystem includes testing crew information management module, test site management module, testing equipment management module and document
It formulates and preserving module, I phase experimental study room management subsystem obtains pilot project by central database unit and manage subsystem
Project data information in system generates and issues Item announcements and information to clinical test related personnel.Testing crew message tube
Module is managed according to the project data information of acquisition, is arrogated to oneself by the key data of clinical test project data information with testing crew
The mode that long technical field matches chooses suitable researcher, and grinding selection in testing crew information management module
Study carefully personal information and carries out record preservation in real time in document formulation and preserving module.Testing equipment management module is according to project data
Information configuration testing equipment generates testing equipment information, and testing equipment information is carried out in document formulation and preserving module
Record saves in real time.Test site management module chooses test site according to project data information, generates test site information, and
Test site information is carried out to record in real time to save in document formulation and preserving module.
Further, referring to Fig. 5, in clinical trial phase management system provided in an embodiment of the present invention, pilot project pipe
Manage the structural schematic diagram of subsystem.In clinical trial phase management system provided in an embodiment of the present invention, pilot project management
System includes project release module, drug maintenance module and subject recruitment information issuing module.Project release module is according to Shen
The publication instruction publication item related information for the person of doing, and item related information is sent to Ethics Committee's evaluation subsystem to item
Mesh carries out the assessment audit of ethics.Drug maintenance module extracts clinical medicine information according to item related information and is deposited into
In drug maintenance module.Subject recruitment information issuing module is used for after project release module issues item related information,
Arrange clinical medicine information and storage inside with clinical medicine information can correspondingly bear the project clinical test by
The every of examination person checks data standard, publication clinical test subject recruitment information to subject data management subsystem.
A clinical trial phase management system provided by the embodiment of the present invention, including work station subsystem, subject data
Management subsystem, I phase experimental study room management subsystem, pilot project management subsystem and Ethics Committee evaluate subsystem；
Wherein, work station subsystem respectively with subject data management subsystem, I phase experimental study room management subsystem and pilot project
Bi-directional data connection is carried out between management subsystem；Pilot project management subsystem is connect with Ethics Committee's evaluation subsystem.
The technical solution carries out data with each functional subsystem respectively by using work station subsystem and docks, and tries for I phase clinic
The feature of testing has adjusted data management structure and data file interactive mode, by clinical test project respectively with subject data and
Research department's management combines, and the equipment of the application approval, clinical experimental study room that realize clinical test project uses and personnel
Scheduling and the screening of clinical test subject, notice and data save, and then the unification for realizing Phase I clinical trial is moved online
The information system management of state improves clinical trial management efficiency, meanwhile, which provides item for manager and reminds, further
It improves user experience, improve the efficiency of management, alleviate Phase I clinical trial information system management difficulty of the existing technology
Technical problem.
Embodiment two:
Referring to Fig. 6, the flow chart of clinical trial phase management method provided in an embodiment of the present invention.It is provided in an embodiment of the present invention
One clinical trial phase management method, comprising the following steps:
(1) input terminal of pilot project management subsystem receives the project application of the clinical experimental study of sponsor, and carries out item
The typing of mesh content, while the contents of a project to Ethics Committee's evaluation subsystem being submitted to carry out moral check examination；
(2) Ethics Committee's evaluation subsystem carries out Ethic review to the contents of a project of submission, after Ethic review, by ethics
Examination result feeds back typing to pilot project management subsystem, if Ethic review evaluation passes through, pilot project management subsystem
Item number is generated according to the contents of a project of submission it is believed that ceasing, and carry out item related information publication；
(3) input terminal of I phase experimental study room management subsystem obtains project data information by work station subsystem, generates simultaneously
The information of output test facility information and test site, and by project initiation situation and arrange to save with document form to text
In shelves formulation and preserving module；And researcher is chosen according to project data information, while issuing to the researcher of selection
Item announcements notify it to prepare clinical test；
(4) after item related information publication, the drug maintenance module of pilot project management subsystem is according in project data information
Item related information, extract clinical medicine information simultaneously be deposited into drug maintenance module, subject recruitment information publication
Module combination clinical medicine information and project data information arrange the every inspection for the subject for being able to bear the project clinical test
Data standard is looked into, and clinical test subject recruitment information is issued by subject recruitment information issuing module；
(5) subject enters group data cell and is generated and its unique corresponding identity according to the essential information for being recruited subject's submission
Bar code checks that data cell carries out a medical examination and physico-chemical examination to being recruited subject, and generates and be recruited subject's
Inspection result data；Subject enters a group data cell and obtains and save inspection result data, and screening, root is compared to the data
According to check data standard choose it is satisfactory be recruited subject as subject, and the selection result is sent to be recruited by
Examination person notifies subject to prepare to participate in clinical test, while the attribute for being recruited subject being labeled as passing through into group；
(6) after subject handles the staying-in-hospital procedures of clinical test, by doctor's advice report generation unit according to the physique of subject
It checks and the inspection result data of physico-chemical examination generates doctor's advice report, be sent to test data unit, while being sent to research people
Member verifies and confirms with clinician, doctor's advice information is compared in time during the test, by nurse's Dynamic Execution doctor's advice
Points for attention；
(7) enter the real-time observation stage of clinical test, test data unit tracks clinical test process to subject and records
Clinical testing data updates the real-time record of result progress of being hospitalized and observe of subject, while generating and recording clinical test number
According to statistical report form or statistical report and store；Specifically, observing the stage in real time in clinical test, test data unit is seen in real time
The case where subject takes drugs front and back is examined, main includes nervous system, digestive system, bleeding and the adverse events of subject
The status tracking of inspection, and, the vital sign of subject's temperature pulse respiration, systolic pressure carries out above-mentioned data real-time
Record updates, and generates the statistical report form for recording clinical testing data or report and stores.
(8) case report form generation unit is according to the identity bar shaped of clinical testing data and doctor's advice report generation and subject
The corresponding case report form of code.
Further, in clinical trial phase management method provided in an embodiment of the present invention, in step (3), the I phase is tested
Research department's management subsystem generates and the information of output test facility information and test site, specifically:
Testing crew information management module is believed according to project data information, by the matched mode of key data in testing crew
Researcher is chosen in breath management module, all personnel should have and undertake adaptable professional speciality, qualification and the ability of work；
Testing equipment management module generates testing equipment information according to project data information configuration testing equipment；Test site manages mould
Root tuber chooses test site according to project data information, generates test site information.Instrument & equipment management is responsible for by special messenger；Instrument is set
Standby operator has appropriate qualification and passes through training on operation, uses equipment according to corresponding uses；Instrument and equipment has clearly label
It indicates its date of manufacture and operating status, and is safeguarded, detected and calibrated；Instrument and equipment is advised with operable standard operation
Journey, and retain the recording documents of all operation and maintenances；Ensure that special messenger carries out quality control checking to test facilities equipment in due course,
Filing management is carried out to instrument data；The instrument and equipment for ensuring to test ward meets the related request of country.Ward is tested to be equipped with
The equipment with function is supported, such as ECG monitor, electrocardiograph, defibrillator and ventilator are monitored with vital sign, and is had
There are oxygen supply and negative pressure suction device.Ward is tested in test site, and there is the development I phase to test required space, have relatively independent
, the ward area of good security, ensure the safety and privacy of subject.Equipped with archive office, drug storage and prepare
Room, pantry and monitor office.The ability that there is original place to rescue and change the place of examination rapidly in test ward is equipped with rescue room, tool
It is necessary to rescue, monitor equipment and common first-aid medicine, emergencycallboxsystem etc., it is ensured that subject is robbed in time
It rescues.
Further, in clinical trial phase management method provided in an embodiment of the present invention, further includes:
(9) project data that the system transaction management unit in work station subsystem will be sent according to pilot project management subsystem
Information generates project item, and project item includes work calendar, project process record and outstanding work, and to outstanding work and
Critical event is reminded；User sets transaction management unit reception researcher and passes through user terminal according to the development of projects situation
Work plan, memorandum, meeting schedule and the reminded contents of reservation of typing generate user and set item.Wherein, subsystem is automatic
The project of login user is subjected to matching screening, shows Institutional Review situation, Ethic review result, project status, project and enters
The information such as group progress, item file situation.In addition, personal work is reminded, item is divided into system automatically generated, user sets item.
It is the prompting item being created by item nodes that system, which generates item, and pending item, generation are serious not such as in workflow
Good event is held notice of meeting, notice of meeting of project initiation meeting of project preparation meeting etc. and is reminded.User can also set work meter
It draws, memorandum, meeting schedule, the reminded contents such as reservation.
Further, in clinical trial phase management method provided in an embodiment of the present invention, further includes:
(10) central database unit in work station subsystem carries out generation, the circulation of data, file in abovementioned steps
Record saves in real time, and will save and the data of record, file shows.
A clinical trial phase management method provided by the embodiment of the present invention, firstly, pilot project management subsystem is defeated
Enter the project application that end receives the clinical experimental study of sponsor, and carries out the typing of the contents of a project, while submitting the contents of a project
Moral check examination is carried out to Ethics Committee's evaluation subsystem, after Ethic review evaluation passes through, pilot project management subsystem is then
Item number is generated according to the contents of a project of submission it is believed that ceasing, and carry out item related information publication；Secondly, I phase experimental study room
Management subsystem generates and the information of output test facility information and test site, chooses research people according to project data information
Member notifies it to prepare clinical test；Pilot project management subsystem combination clinical medicine information and project data information, publication are faced
Bed test subject recruitment information；Then, subject enters group data cell and carries out a medical examination and physical and chemical to being recruited subject
It checks, is recruited subject as subject according to checking that data standard selection is satisfactory, subject is notified to prepare to participate in
Clinical test；Finally, doctor's advice report generation unit is raw according to the physical examination of subject and the inspection result data of physico-chemical examination
It is reported at doctor's advice；Test data unit tracks clinical test process to subject and records clinical testing data, to subject's
In hospital and observation result carries out record in real time and updates；Case report form generation unit is according to clinical testing data and doctor's advice report life
At case report form corresponding with the ID bar code of subject.The technical solution by using work station subsystem respectively and respectively
A functional subsystem carries out data docking, has adjusted data management structure for Phase I clinical trial feature and data file is handed over
Clinical test project is combined with subject data and research department's management respectively, realizes clinical test project by mutual mode
Application approval, the equipment use of clinical experimental study room and personal scheduling and the screening of clinical test subject, notice sum number
According to preservation, and then the unification dynamic information system management online of Phase I clinical trial is realized, improves clinical trial management effect
Rate, meanwhile, which provides item for manager and reminds, and further improves user experience, improves the efficiency of management, alleviates
The technical problem of Phase I clinical trial information system management difficulty of the existing technology.
Finally, it should be noted that embodiment described above, only a specific embodiment of the invention, to illustrate the present invention
Technical solution, rather than its limitations, scope of protection of the present invention is not limited thereto, although with reference to the foregoing embodiments to this hair
It is bright to be described in detail, those skilled in the art should understand that: anyone skilled in the art
In the technical scope disclosed by the present invention, it can still modify to technical solution documented by previous embodiment or can be light
It is readily conceivable that variation or equivalent replacement of some of the technical features；And these modifications, variation or replacement, do not make
The essence of corresponding technical solution is detached from the spirit and scope of technical solution of the embodiment of the present invention, should all cover in protection of the invention
Within the scope of.Therefore, protection scope of the present invention should be based on the protection scope of the described claims.
Claims (10)
1. a clinical trial phase management system, which is characterized in that including the station subsystem, subject data management subsystem, I of working
Phase experimental study room management subsystem, pilot project management subsystem and Ethics Committee evaluate subsystem；Wherein, the work
Station subsystem manages subsystem with subject data management subsystem, I phase experimental study room management subsystem and pilot project respectively
Bi-directional data connection is carried out between system；The pilot project management subsystem is connect with Ethics Committee evaluation subsystem；
The input terminal of the pilot project management subsystem receives the project application of sponsor, and carries out the typing of the contents of a project,
It submits the contents of a project to Ethics Committee's evaluation subsystem to carry out Ethic review, and receives the Ethic review of feedback as a result, generating
The project data information of generation is sent respectively to sponsor and is recruited object by project data information；
The input terminal of the I phase experimental study room management subsystem item number obtained by the work station subsystem it is believed that
Breath, and researcher is chosen according to the project data information, Item announcements are simultaneously emitted by the researcher chosen；The I
Phase experimental study room management subsystem also generates and output test facility information and test site information, and by project initiation situation
And it arranges to be saved with document form into document formulation and preserving module；
The physique for being recruited subject that the input terminal acquisition of the subject data management subsystem is transmitted by testing equipment and
Physico-chemical examination data, and the selected subject for participating in clinical test of integration project data information, record the clinical test of subject
Data generate the case report form and doctor's advice report of subject；
The work station subsystem receives the project data information that the pilot project management subsystem is sent, according to the project
Data information generates project item；It is set also according to received user and generates user and set item, and by project item and user
Setting item is sent to its corresponding terminal；And to the generations of data, file before and after clinical test process, circulate into
Record saves row in real time, and will save and the data of record, file shows.
2. a clinical trial phase management system according to claim 1, which is characterized in that the subject data manages subsystem
System includes that subject enters a group data cell, checks data cell, test data unit, case report form generation unit and doctor's advice report
Accuse generation unit；
The subject enters group data cell and is generated and its unique corresponding body according to the essential information for being recruited subject's submission
Part bar code；The inspection data cell is made of physical data module and physico-chemical examination data module, for quilt
Subjects recruitment carries out a medical examination with physico-chemical examination and generation is recruited the inspection result data of subject；The inspection result
Data include physical data and physico-chemical examination data；The subject enters group data cell and obtains the inspection result number
According to, and screening is compared to the data, selection is satisfactory to be recruited subject as subject, and the selection result is sent out
It gives and is recruited subject, while the attribute for being recruited subject being labeled as passing through into group；
The doctor's advice report generation unit generates doctor's advice report according to the inspection result data；
The test data unit includes hospitalization data management module, administration data management module, blood sampling data management module, sees
It examines data management module and adverse events generate and reminding module, for tracking the clinical test process of subject and recording clinic
Test data；
The case report form generation unit is according to the clinical testing data and the body of the doctor's advice report generation and subject
The corresponding case report form (Case Report Form, abbreviation CRF) of part bar code.
3. a clinical trial phase management system according to claim 1, which is characterized in that during the work station subsystem includes
Database Unit and system transaction management unit connected to it, user is entreated to set transaction management unit and display unit；
The system transaction management unit is used by connecting between central database unit and the pilot project management subsystem
According to the project data information generation project item sent according to the project management subsystem, the project item
The prompting item of item nodes creation in the project data information, and project item is sent to the display unit and is carried out
Item is shown；
The user sets transaction management unit and also receives user's setting that researcher is submitted by user terminal, and according to
Family setting and project data information generate user and set item, and user's setting item is sent to the display unit and carries out thing
Item display；
The central database unit also connects with subject data management subsystem and I phase experimental study room management subsystem respectively
Connect realization data interaction.
4. a clinical trial phase management system according to claim 3, which is characterized in that the system transaction management unit packet
It includes work calendaring module and project process logging modle connected to it, outstanding work reminding module and critical event reminds mould
Block；
The project process logging modle, outstanding work reminding module and critical event reminding module also respectively with the test item
The connection of mesh management subsystem；
The project process logging modle is used to generate project process item according to the project data information；The outstanding work
Reminding module and critical event reminding module are used to generate project process item according to the project data information；Critical event mentions
Module of waking up is used to generate project process item according to the project data information.
5. a clinical trial phase management system according to claim 1, which is characterized in that the I phase experimental study room management
Subsystem include testing crew information management module, test site management module, testing equipment management module and document formulate and
Preserving module, I phase experimental study room management subsystem generate and issue Item announcements and information to clinical test relevant people
Member；
The testing crew information management module is being tried according to the project data information by the matched mode of key data
It tests in personnel information management module and chooses researcher, and by researcher's information of selection in document formulation and preserving module
Record in real time is carried out to save；
Testing equipment management module generates testing equipment information according to the project data information configuration testing equipment, and will examination
It tests facility information and carries out record preservation in real time in document formulation and preserving module；
Test site management module chooses test site according to the project data information, generates test site information, and will examination
It tests place information and carries out record preservation in real time in document formulation and preserving module.
6. a clinical trial phase management system according to claim 1, which is characterized in that the pilot project management subsystem
Including project release module, drug maintenance module and subject recruitment information issuing module；
The project release module instructs publication item related information according to the publication of sponsor, and item related information is sent
The assessment for carrying out ethics to project to Ethics Committee's evaluation subsystem is audited；
The drug maintenance module extracts clinical medicine information according to item related information and is deposited into drug maintenance module
In；
The subject recruitment information issuing module is used for after project release module issues item related information, and arrangement can
It bears the every of the subject of the project clinical test and checks data standard, issue clinical test subject recruitment information.
7. a clinical trial phase management method, it is characterised in that the following steps are included:
(1) input terminal of pilot project management subsystem receives the project application of sponsor, and carries out the typing of the contents of a project, together
When submit the contents of a project to Ethics Committee evaluation subsystem carry out moral check examination；
(2) Ethics Committee's evaluation subsystem carries out Ethic review, and Ethic review result is fed back to pilot project management subsystem
System, if evaluation passes through, pilot project management subsystem generates item number it is believed that ceasing, and carry out item related information publication；
(3) input terminal of I phase experimental study room management subsystem obtains project data information by work station subsystem, generates simultaneously
The information of output test facility information and test site, and by project initiation situation and arrange to save with document form to text
In shelves formulation and preserving module；And researcher is chosen according to project data information, while issuing to the researcher of selection
Item announcements notify it to prepare clinical test；
(4) after item related information publication, the drug maintenance module of pilot project management subsystem is mentioned according to item related information
It takes clinical medicine information and is deposited into drug maintenance module, subject recruitment information issuing module combination clinical medicine letter
Breath and project data information arrange the every of the subject for being able to bear the project clinical test and check data standard, and by by
Examination person recruits information issuing module and issues clinical test subject recruitment information；
(5) subject enters group data cell and is generated and its unique corresponding identity according to the essential information for being recruited subject's submission
Bar code checks that data cell carries out a medical examination and physico-chemical examination to being recruited subject, and generates and be recruited subject's
Inspection result data；Subject enters a group data cell and obtains and save the inspection result data, and sieve is compared to the data
Choosing, according to check data standard choose it is satisfactory be recruited subject as subject, and by the selection result be sent to by
Subjects recruitment notifies subject to prepare to participate in clinical test, while the attribute for being recruited subject being labeled as leading into group
It crosses；
(6) after subject handles the staying-in-hospital procedures of clinical test, by doctor's advice report generation unit according to the physique of subject
It checks and the inspection result data of physico-chemical examination generates doctor's advice report, be sent to test data unit, while being sent to research people
Member verifies and confirms with clinician；
(7) enter the real-time observation stage of clinical test, test data unit tracks clinical test process to subject and records
Clinical testing data updates the real-time record of result progress of being hospitalized and observe of subject, while generating and recording clinical test number
According to statistical report form or statistical report and store；
(8) case report form generation unit is according to the identity of the clinical testing data and the doctor's advice report generation and subject
The corresponding case report form of bar code.
8. a clinical trial phase management method according to claim 7, which is characterized in that in step (3), the I phase is tested
Research department's management subsystem generates and the information of output test facility information and test site, specifically:
Testing crew information management module is according to the project data information, by the matched mode of key data in test people
Researcher is chosen in member's information management module；Testing equipment management module is set according to project data information configuration test
It is standby, generate testing equipment information；Test site management module chooses test site according to the project data information, generates test
Place information.
9. a clinical trial phase management method according to claim 7, which is characterized in that further include:
(9) project data that the system transaction management unit in work station subsystem will be sent according to pilot project management subsystem
Information generates project item, and project item includes work calendar, project process record and outstanding work, and to outstanding work and
Critical event is reminded；User sets transaction management unit reception researcher and passes through user terminal according to the development of projects situation
Work plan, memorandum, meeting schedule and the reminded contents of reservation of typing generate user and set item.
10. a clinical trial phase management method according to any one of claim 7 to 9, which is characterized in that further include:
(10) central database unit in work station subsystem carries out generation, the circulation of data, file in abovementioned steps
Record saves in real time, and will save and the data of record, file shows.
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Application publication date: 20190528 |