CN109817291A - Clinical test document file management system and management method - Google Patents
Clinical test document file management system and management method Download PDFInfo
- Publication number
- CN109817291A CN109817291A CN201811590712.8A CN201811590712A CN109817291A CN 109817291 A CN109817291 A CN 109817291A CN 201811590712 A CN201811590712 A CN 201811590712A CN 109817291 A CN109817291 A CN 109817291A
- Authority
- CN
- China
- Prior art keywords
- document
- clinical test
- file
- data
- clinical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 238000012360 testing method Methods 0.000 title claims abstract description 355
- 238000007726 management method Methods 0.000 title claims abstract description 139
- 230000007246 mechanism Effects 0.000 claims abstract description 67
- 238000003860 storage Methods 0.000 claims abstract description 26
- 238000012790 confirmation Methods 0.000 claims description 64
- 238000013523 data management Methods 0.000 claims description 28
- 230000006378 damage Effects 0.000 claims description 16
- 230000008520 organization Effects 0.000 claims description 9
- 239000000126 substance Substances 0.000 claims description 7
- 238000002360 preparation method Methods 0.000 claims description 6
- 238000011160 research Methods 0.000 claims description 5
- 238000012546 transfer Methods 0.000 claims description 5
- 238000003255 drug test Methods 0.000 claims description 4
- 238000003032 molecular docking Methods 0.000 claims description 3
- 235000013399 edible fruits Nutrition 0.000 claims 1
- 238000005516 engineering process Methods 0.000 abstract description 9
- 239000003814 drug Substances 0.000 description 11
- 229940079593 drug Drugs 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- 230000008569 process Effects 0.000 description 5
- 230000005540 biological transmission Effects 0.000 description 3
- 238000012384 transportation and delivery Methods 0.000 description 3
- 230000002411 adverse Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 238000004321 preservation Methods 0.000 description 2
- 230000007115 recruitment Effects 0.000 description 2
- 238000012549 training Methods 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 230000001934 delay Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
Landscapes
- Medical Treatment And Welfare Office Work (AREA)
Abstract
The present invention provides a kind of clinical test document file management system and management methods, it is related to clinical testing data administrative skill field, includes clinical test document coding subsystem, clinical test document classification storage subsystem and clinical test document management subsystem in the technical solution；Wherein, clinical test document management subsystem generates clinical test document for collecting the relevant document of clinical test and data；Clinical test document coding subsystem uses mechanism profession code mechanism, for being classified and being worked out corresponding unique document identifier code to document；Clinical test document classification storage subsystem carries out classified and stored to encoded document.The technical solution alleviates the technical problem of clinical testing data document query difficulty of the existing technology, realize the effective position and inquiry of clinical testing data and document, clinical test related personnel's document management efficiency is improved, clinical test related personnel is facilitated and arrangement classification is carried out to clinical testing data.
Description
Technical field
The present invention relates to clinical testing data administrative skill fields, more particularly, to a kind of clinical test document file management system
And management method.
Background technique
With being constantly progressive for clinical technique, more and more clinical tests get the nod, and healthcare structure is also encouraged
Medical investigator breaks through conventional Experiment on white mice in the drug test stage, is recruited according to the requirement of clinical test project and feature
Subject participates in clinical test, facilitates the breakthrough of drug research achievement.There are many link during clinical test, mainly
It is divided into four-stage, i.e. clinical test project application and approval process, subject recruitment and physique physico-chemical examination, subject is admitted to hospital
Data preparation four-stage after receiving clinical test and testing.This requires the relevant research of clinical test project and works
Make personnel all data progress in four-stage is accurately recorded, integrated, summarized, report and saved in real time, not only occupy
Manpower, and because data information it is many kinds of, be not easy to arrange and sort out, when preservation is even more time-consuming and laborious, after being also not easy to
Continuous inquiry of the staff to every data and data.
The database system structure of existing file management is simple, and is only to realize using database technology to data
It is stored, it is normative not high, and management mode and cannot have a single function according to carrying out Classifying Sum the characteristics of data, it is clinical
It tests the data being related to and number of documents is huge, it is existing because it has the characteristics that different data in clinical test process each stage
File management be difficult to realize the quick positioning and lookup of test data and document, seriously reduce clinical testing data management effect
Rate.Therefore, there are the technical problems of clinical testing data document query difficulty for the prior art.
Summary of the invention
In view of this, the purpose of the present invention is to provide a kind of clinical test document file management system and management method, with slow
Solve the technical problem for checking on clinical testing data line of the existing technology and querying difficulty.
In a first aspect, the embodiment of the invention provides a kind of clinical test document file management systems, comprising: clinical test document
Code-subsystem, clinical test document classification storage subsystem and clinical test document management subsystem；Wherein, clinical test text
Shelves management subsystem generates clinical test document, output end and clinic for collecting the relevant document of clinical test and data
Test the input terminal connection of document coding subsystem；Clinical test document coding subsystem uses mechanism/profession code mechanism, uses
In being classified to document and work out corresponding unique document identifier code；Clinical test document classification storage subsystem pair
Encoded document carries out classified and stored；
Wherein, document coding subsystem includes document classification administrative unit and document identifier code creating unit；Document classification management
Unit receives the clinical archive file tablet menu that clinical test file generated and profiling unit are sent and clinical test is put on record table, and
The file content keyword given according to archivist relevant classification of selecting file in mechanism/profession code mechanism, it is raw
At file tabulation；The document classification list that document identifier code creating unit is generated according to document classification administrative unit, and create
Build with the unique corresponding document identifier code of file, this document identifier code is sent to sponsor or school researcher, and will put on record
Information is sent to archivist.
Further, in clinical test document file management system provided in an embodiment of the present invention, the relevant document of clinical test
And data include the clinical test number during the clinical test application documents of sponsor or school researcher proposition, clinical test
Accordingly and subject data；Document classification storage subsystem includes mechanism document library unit and project document library unit；Project text
Shelves library unit includes item data management module and data acquisition and management module.
Further, in clinical test document file management system provided in an embodiment of the present invention, clinical test document management
System includes that clinical testing data submits unit, clinical test file handover confirmation unit, clinical test file generated and filing
Unit and clinical test file destroy application and confirmation unit；Clinical testing data submits unit for receiving sponsor or school
The clinical testing data that researcher provides, and enabling signal to file is sent by its output end and joins confirmation unit；Clinical test
File joins confirmation unit and is notified by page end or user terminal transmission to sponsor or school researcher according to enabling signal,
The clinical testing data of submission is confirmed by sponsor or school researcher；Clinical test file generated and profiling unit pair
Clinical testing data after confirmation carries out summarizing arrangement, generates and sends clinical archive file tablet menu and clinical test is put on record
The output end of table, clinical test file generated and profiling unit is connect with clinical test document coding subsystem.
Further, in clinical test document file management system provided in an embodiment of the present invention, data submit unit include by
Examination person's data management module, clinical testing data management module and clinical test application documents management module；Subject data pipe
Subject data in reason module includes grinding during the physical data of subject, physico-chemical examination data, clinical test
Study carefully the basic condition and registration card number of medical record data, case report form (Case Report Form, CRF) data and subject
According to；Clinical testing data in clinical testing data management module include clinical test results data during clinical test and
Standard parameter data；Clinical test application documents in clinical test application documents management module include sponsor or school's research
What member proposed comments about the term of reference data of drug test, risk profile during clinical test application document, clinical test
Estimate data and prediction of result data.
Further, in clinical test document file management system provided in an embodiment of the present invention, file destroys application and confirmation
Unit is used for after the destruction application that receiving archives administrator proposes, sponsor or school are sent by way of mail or short message
The file content and carry out Electronic Signature confirmation that researcher is destroyed, are confirmed after destruction feedback, expire to keeping
Document destroyed.
Further, in clinical test document file management system provided in an embodiment of the present invention, mechanism/profession code mechanism packet
Include organization's class document and pilot project class document；
Organization's class document includes: system functions catalogue, emergency preplan catalogue and standard practice instructions catalogue；
Pilot project class document includes: experimental study team catalogue, clinical test preparation stage catalogue, clinical test progress stage
Catalogue and clinical test other catalogues after the completion of catalogue, clinical test.
Further, in clinical test document file management system provided in an embodiment of the present invention, include: in document classification list
Classification sequence number, file class title, classification coding and parent coding.
Second aspect, the embodiment of the invention provides a kind of clinical test document management methods, comprising the following steps:
(1) clinical test document file management system distributes sponsor, school researcher, archivist, mechanism and department doctor
Permission, system are declared file, managed and are consulted according to Permission Levels；
(2) data of clinical test document management subsystem submit the clinical test application documents management module in unit to receive Shen
The application for the clinical test related data typing that the person of doing or school researcher submit, after application passes through, clinical testing data management
Module and clinical test application documents management module execute data inputting, and transfer to archivist to examine the data of typing
Core；
(3) the clinical testing data management module of clinical test document management subsystem by internet receive department doctor to by
The related data that examination person carries out a medical examination with physico-chemical examination, subject data management module records subject related data and by
Examination person knows book, and sponsor or school researcher, supervisor and archivist can inquire data；
(4) after the completion of data inputting, the short message or mail that confirmation is submitted are issued by file handover confirmation unit, in data submitter
After confirmation, file joins confirmation unit and data is transferred to file generated and profiling unit, and file generated and profiling unit are to data
It carries out summarizing arrangement, generates and sends archive file and clinical test is put on record table, and be sent to archivist's confirmation；
(5) clinical test document coding subsystem receives the archive file after confirmation, document classification administrative unit by internet
It receives clinical archive file tablet menu that clinical test file generated and profiling unit are sent and clinical test is put on record table, and according to
The file content keyword that archivist gives relevant classification of selecting file in mechanism/profession code mechanism generates text
Part tabulation；Document identifier code creating unit receive document classification administrative unit generate document classification list, and create with
This document identifier code is sent to sponsor or school researcher by the unique corresponding document identifier code of file, and by record information
It is sent to archivist；
(6) document classification storage subsystem receives and stores the file after coding, sponsor or school researcher, file administration
Member, mechanism and department doctor can inquire the file of tape file identification code according to permission；
(7) file destroys application and confirmation unit, after the destruction application that receiving archives administrator proposes, passes through mail or short message
Mode send file content that sponsor or school researcher are destroyed and carry out Electronic Signature confirmation；It is confirmed pin
It ruins after feedback, is destroyed according to file and the document expired to keeping is required to destroy, and dated, while by Destruction
In file submit clinical test document file management system.
Further, in clinical test document management method provided in an embodiment of the present invention, the handover of clinical test file is true
Recognize unit and also receive the unloading application of the expired file without destroying, and receives the essential information of third party's file management mechanism,
Waiting system confirmation；After completing confirmation, the expired file that need to be destroyed is sent to third party's file management mechanism keeping archives text
Part is performed simultaneously unloading signature confirmation, and records the unloading date；Meanwhile the record file in unloading handshaking being committed to
The mechanism document library unit of clinical test document classification storage subsystem.
Further, in clinical test document management method provided in an embodiment of the present invention, further include and sponsor, school
The electronic signature of researcher, archivist and department doctor docking confirm subsystem, after operator executes operation, electronics
Signature Confirmation subsystem carries out electronic signature confirmation；It signs electronically to be fingerprinting operation, face recognition operation, iris recognition operation
Or stamped signature operation.
The embodiment of the present invention brings following the utility model has the advantages that clinical test document management system provided by the embodiment of the present invention
System and management method, system include clinical test document coding subsystem, clinical test document classification storage subsystem and clinic
Test document management subsystem；Wherein, clinical test document management subsystem is for collecting the relevant document of clinical test and number
According to generation clinical test document；Clinical test document coding subsystem use mechanism/profession code mechanism, be used for document into
Row classifies and works out corresponding unique document identifier code；Clinical test document classification storage subsystem is to encoded text
Shelves carry out classified and stored.Wherein, document coding subsystem includes document classification administrative unit and document identifier code creating unit；Text
Part Classification Management unit receives the clinical archive file tablet menu that clinical test file generated and profiling unit are sent and clinical examination
Test table of putting on record, and the file content keyword given according to archivist selecting file phase in mechanism/profession code mechanism
The classification of pass generates document classification list；Document identifier code creating unit creates unique with file according to document classification list
This document identifier code is sent to sponsor or school researcher, and record information is sent to shelves by corresponding document identifier code
Case administrator.The technical solution is by using clinical test document coding, the storage of clinical test document classification and clinical test text
Shelves management combines, and it is suitable that document coding subsystem therein can carry out height with the phase characteristic of clinical test project data
Match, realize the effective position and inquiry of clinical testing data and document, improves clinical test related personnel's document management effect
Rate facilitates clinical test related personnel and carries out arrangement classification to clinical testing data, further improves clinical testing data
The intelligence degree of management realizes clinical test related personnel to managing on the efficient line of clinical testing data and document, delays
The technical problem of clinical testing data document query difficulty of the existing technology is solved.
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 test document file management system provided in an embodiment of the present invention；
Fig. 2 is the flow chart of clinical test document 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.
It currently, the database system structure of existing file management is simple, and is only to realize to utilize database technology
Data are stored, it is normative not high, and cannot be according to carrying out Classifying Sum, management mode and function list the characteristics of data
One, the data and number of documents that clinical test is related to are huge, because it has different data special in clinical test process each stage
Point, existing file management are difficult to realize the quick positioning and lookup of test data and document, seriously reduce clinical test number
According to the efficiency of management, it is based on this, clinical test document file management system provided in an embodiment of the present invention and management method may be implemented to face
Bed test related personnel can carry out risk judgment and query to intervene to the test data during clinical test, face to realize
It checks and queries on the line of bed test data.
Embodiment one:
Referring to Fig. 1, the structural schematic diagram of clinical test document file management system provided in an embodiment of the present invention.The embodiment of the present invention mentions
The clinical test document file management system of confession, comprising: clinical test document coding subsystem, clinical test document classification store subsystem
System and clinical test document management subsystem；Wherein, clinical test document management subsystem is relevant for collecting clinical test
Document and data, generate clinical test document, and output end is connect with the input terminal of clinical test document coding subsystem；It is clinical
Test document coding subsystem use mechanism/profession code mechanism, for classified to document and worked out it is corresponding only
One document identifier code；Clinical test document classification storage subsystem carries out classified and stored to encoded document.
Wherein, document coding subsystem includes document classification administrative unit and document identifier code creating unit；Document classification
Administrative unit receives the clinical archive file tablet menu that clinical test file generated and profiling unit are sent and clinical test is put on record
Table, and the file content keyword given according to archivist is relevant point of selecting file in mechanism/profession code mechanism
Class generates document classification list；Further, in clinical test document file management system provided in an embodiment of the present invention, file point
It include: classification sequence number, file class title, classification coding and parent coding in class list.Document identifier code creating unit according to
The document classification list that document classification administrative unit generates, and create with the unique corresponding document identifier code of file, by this file
Identification code is sent to sponsor or school researcher, and record information is sent to archivist.The technical solution is to use
The document file management system that data base administration and Internet technology combine, system structure is simple, multiple functional, can be to facing
Data during bed test automatically generate file and are saved, and reduce the document management burden of department management person, facilitate
The realization of with no paper operation.
Further, in clinical test document file management system provided in an embodiment of the present invention, mechanism/profession code mechanism packet
Include organization's class document and pilot project class document.Specifically, the document classification of clinical test document file management system is divided into two
Major class, organization's type and pilot project type.The file of all storages is grouped storage all in accordance with such in system.Mechanism group
Knit the JGZZ that is encoded to of type, and pilot project type is encoded to SYXM.The subject management of organization's type is by archives
Administrator is managed maintenance, and the file of pilot project type uploads and management is operated by school researcher.
Organization's class document includes: system functions catalogue, emergency preplan catalogue and standard practice instructions catalogue.Specifically
, system functions catalog code is ZDZZ, and emergency preplan catalog code is YJYY, and standard practice instructions catalog code is SOP.Its
In, system functions catalog system has set the two class subjects that file subject includes: organization management system and job duty.Emergency is pre-
It includes: the file subject that subject damages emergency preplan and emergency event emergency preplan that case, which has set file subject,.Standard operation
It includes: SOP, project operation SOP, clinical test the project verification SOP, clinical test for customizing SOP that process catalog system, which has set subject,
Starting and training SOP, clinical test quality management SOP, clinical trial data file administration SOP, clinical test medication management
SOP, mechanism medication management SOP, adverse events and serious adverse events report processing SOP, subject recruitment SOP, plantation are clinical
Test SOP, test data record SOP, data Management SOP and test concluding SOP.
Pilot project class document includes: experimental study team catalogue, clinical test preparation stage catalogue, clinical test progress
Catalogue and clinical test other catalogues after the completion of stage catalogue, clinical test.Specifically, the coding class of experimental study team catalogue
Type is JGZZ-YJTD, and the type of coding of clinical test preparation stage catalogue is JGZZ-SYZB, clinical test is from stage catalogue
Type of coding is JGZZ-SYJX, after the completion of clinical test catalog code type be JGZZ-SYWC, clinical test other catalogues
Type of coding is JGZZ-QT.
Specifically, test preparation stage catalog system has set file subject, which includes: researcher's handbook, test
Scheme and its amendment, case report form, informed consent form, confidentiality agreement, financial regulation, multilateral accord, ethics official written reply, ethics
Laboratory data before committeeman's table, clinical test application form, clinical test, State Food and Drug Administration's official written reply,
Researcher's resume and its GCP certificate, laboratory range of normal value table, laboratory Quality Control prove, test medicine label, test are used
Drug proof of delivery, test relative article proof of delivery, test drug medicine inspection report, total random table, monitoring report.
Test progress stage catalog system has set file subject, which includes: test relevant supplies proof of delivery, new batch
Number trial drug survey report, monitor's interview report, case report form, researcher cause the SAE report of sponsor, sponsor to cause
The SAE report of CFDA, EC, mid-term or annual report, Subject Screening Log and eligible list, test drug registration form, researcher
Signature specimen page.
Test completion stage catalog system has set file subject, which includes: that trial drug destroys proof, completes examination
Test subject's coding catalogue, inspection proves part, final monitoring report, treatment distributes and unblinding proves, tests completion report, summarizes
Report.Archivist user can to existing file subject carry out secondary maintenance, sponsor, school researcher, can be according to subject
The file of the corresponding classification of the upload of type.
Further, in clinical test document file management system provided in an embodiment of the present invention, the relevant document of clinical test
And data include the clinical test number during the clinical test application documents of sponsor or school researcher proposition, clinical test
Accordingly and subject data；Document classification storage subsystem includes mechanism document library unit and project document library unit；Project text
Shelves library unit includes item data management module and data acquisition and management module.
Further, in clinical test document file management system provided in an embodiment of the present invention, clinical test document management
System includes that clinical testing data submits unit, clinical test file handover confirmation unit, clinical test file generated and filing
Unit and clinical test file destroy application and confirmation unit；Clinical testing data submits unit for receiving sponsor or school
The clinical testing data that researcher provides, and enabling signal to file is sent by its output end and joins confirmation unit；Clinical test
File joins confirmation unit and is notified by page end or user terminal transmission to sponsor or school researcher according to enabling signal,
The clinical testing data of submission is confirmed by sponsor or school researcher；Clinical test file generated and profiling unit pair
Clinical testing data after confirmation carries out summarizing arrangement, generates and sends clinical archive file tablet menu and clinical test is put on record
The output end of table, clinical test file generated and profiling unit is connect with clinical test document coding subsystem.Wherein, user is whole
End is mobile terminal application program or terminal.
Further, in clinical test document file management system provided in an embodiment of the present invention, data submit unit include by
Examination person's data management module, clinical testing data management module and clinical test application documents management module；Subject data pipe
Subject data in reason module includes grinding during the physical data of subject, physico-chemical examination data, clinical test
Study carefully the basic condition and record of medical record data, case report form (Case Report Form, abbreviation CRF) data and subject
Card data；Clinical testing data in clinical testing data management module includes the clinical test results number during clinical test
According to and standard parameter data；Clinical test application documents in clinical test application documents management module include sponsor or school
Term of reference data, the risk about drug test during clinical test application document, clinical test that researcher proposes are pre-
Data and prediction of result data are estimated in assessment.
Further, since the clinical trial data in clinical test document management subsystem without exception must not unofficial biography；Project data
Access is only limitted to the inspector that the researcher, monitor and relevant clinical pilot project sponsor of clinical test appoint.Therefore, institute
There are personnel that must should register by clinical test document management subsystem by saving record in accessed document, steps on
Typing need to be registered by, which clocking, borrows the date, the starting and end time of borrowing, project name, consults content, consult purpose, consult
Simultaneously typing signs electronically and dates for people and its unit, contact method.
Further, in clinical test document file management system provided in an embodiment of the present invention, file destroys application and confirmation
Unit is used for after the destruction application that receiving archives administrator proposes, sponsor or school are sent by way of mail or short message
The file content and carry out Electronic Signature confirmation that researcher is destroyed, are confirmed after destruction feedback, by Authority Profile
Administrator is responsible for witnessing, sign and dating, and office is destroyed according to file and required, and is delivered to hospital archives management portion
Door special messenger destroys, and the document expired to keeping is destroyed, and the file in Destruction is presented a paper management subsystem.
In addition, administrator files an application by Authority Profile after project file keeping expires, application and confirmation are destroyed by file
Unit notifies sponsor or school researcher to confirm, and is provided with responsible person's signature by sponsor and is affixed one's seal and agree to destroy or transfer to
The file of third party's keeping archives.For submitting the archives of third party's preservation, office is transferred to third party according to file
Requirement, join with third party, both sides sign and sign date on handover record.
Clinical test document file management system provided by the embodiment of the present invention, including clinical test document coding subsystem,
Clinical test document classification storage subsystem and clinical test document management subsystem；Wherein, clinical test document management subsystem
System generates clinical test document for collecting the relevant document of clinical test and data；Clinical test document coding subsystem is adopted
With mechanism/profession code mechanism, for being classified and being worked out corresponding unique document identifier code to document；Clinic examination
It tests document classification storage subsystem and classified and stored is carried out to encoded document.Wherein, document coding subsystem includes file point
Class administrative unit and document identifier code creating unit；Document classification administrative unit receives clinical test file generated and profiling unit
The clinical archive file tablet menu of transmission and clinical test are put on record table, and the file content keyword given according to archivist
The relevant classification of selecting file in mechanism/profession code mechanism generates document classification list；Document identifier code creating unit root
According to document classification list, and create with the unique corresponding document identifier code of file, by this document identifier code be sent to sponsor or
School researcher, and record information is sent to archivist.The technical solution by using clinical test document coding, face
Bed test document classification storage is combined with clinical test document management, and document coding subsystem therein can be with clinical test
The phase characteristic of project data carries out height adaptation, realizes the effective position and inquiry of clinical testing data and document, improves
Clinical test related personnel's document management efficiency facilitates clinical test related personnel and arrange to clinical testing data and returns
Class further improves the intelligence degree of clinical testing data management, realizes clinical test related personnel to clinical test
It is managed on the efficient line of data and document, the technology for alleviating clinical testing data document query difficulty of the existing technology is asked
Topic.
Embodiment two:
Referring to fig. 2, the flow chart of clinical test document management method provided in an embodiment of the present invention.It is provided in an embodiment of the present invention
Clinical test document management method, comprising the following steps:
(1) clinical test document file management system distributes sponsor, school researcher, archivist, mechanism and department doctor
Permission, system are declared file, managed and are consulted according to Permission Levels；
(2) data of clinical test document management subsystem submit the clinical test application documents management module in unit to receive Shen
The application for the clinical test related data typing that the person of doing or school researcher submit, after application passes through, clinical testing data management
Module and clinical test application documents management module execute data inputting, and transfer to archivist to examine the data of typing
Core；
(3) the clinical testing data management module of clinical test document management subsystem by internet receive department doctor to by
The related data that examination person carries out a medical examination with physico-chemical examination, subject data management module records subject related data and by
Examination person knows book, and sponsor or school researcher, supervisor and archivist can inquire data；
(4) after the completion of data inputting, the short message or mail that confirmation is submitted are issued by file handover confirmation unit, in data submitter
After confirmation, file joins confirmation unit and data is transferred to file generated and profiling unit, and file generated and profiling unit are to data
It carries out summarizing arrangement, generates and sends archive file and clinical test is put on record table, and be sent to archivist's confirmation；
(5) clinical test document coding subsystem receives the archive file after confirmation, document classification administrative unit by internet
It receives clinical archive file tablet menu that clinical test file generated and profiling unit are sent and clinical test is put on record table, and according to
The file content keyword that archivist gives relevant classification of selecting file in mechanism/profession code mechanism generates text
Part tabulation；Document identifier code creating unit receive document classification administrative unit generate document classification list, and create with
This document identifier code is sent to sponsor or school researcher by the unique corresponding document identifier code of file, and by record information
It is sent to archivist；
(6) document classification storage subsystem receives and stores the file after coding, sponsor or school researcher, file administration
Member, mechanism and department doctor can inquire the file of tape file identification code according to permission.Using mechanism/profession code mechanism, press
It is encoded according to title phonetic upper-case first letters.Set up mechanism document code mechanism, office determine mechanism/profession department major class
Code.Mechanism file divides system functions (ZDZZ), emergency preplan (YJYY) and standard practice instructions (SOP) three classes.Establish profession
Department's document code mechanism.By Classification Management function, document classification list can be inquired.Tabulation includes serial number, files classes
The attributes such as alias claims, classification encodes, parent encodes, creation time, founder.Administration class data is mechanism profession department
Managerial data.Including the files such as clinical test items system and responsibility, standard practice instructions, first aid prediction scheme correlation training record.
Administration record material is by Authority Profile administrator department archivist respectively according to mechanism and professional department data range
Management, researcher can consult at any time.
(7) file destroys application and confirmation unit, after the destruction application that receiving archives administrator proposes, by mail or
The mode of short message sends the file content that sponsor or school researcher are destroyed and carries out Electronic Signature confirmation；It obtains really
Recognize after destruction feedback, destroyed according to file and the document expired to keeping is required to destroy, and dated, while will destroy
File in the process submits clinical test document file management system.The technical solution improves the data management efficiency of clinical test,
It can be realized real-time tracking document status, improve the quality and integrality of clinical research document, avoid making for paper document
With with it is cumbersome management, save and etc., reduce the management cost of clinical test file.
Further, in clinical test document management method provided in an embodiment of the present invention, the handover of clinical test file is true
Recognize unit and also receive the unloading application of the expired file without destroying, and receives the essential information of third party's file management mechanism,
Waiting system confirmation；After completing confirmation, the expired file that need to be destroyed is sent to third party's file management mechanism keeping archives text
Part is performed simultaneously unloading signature confirmation, and records the unloading date；Meanwhile the record file in unloading handshaking being committed to
The mechanism document library unit of clinical test document classification storage subsystem.
Further, in clinical test document management method provided in an embodiment of the present invention, further include and sponsor, school
The electronic signature of researcher, archivist and department doctor docking confirm subsystem, after operator executes operation, electronics
Signature Confirmation subsystem carries out electronic signature confirmation；It signs electronically to be fingerprinting operation, face recognition operation, iris recognition operation
Or stamped signature operation.
Clinical test document management method provided by the embodiment of the present invention, firstly, clinical test document file management system pair
Sponsor, school researcher, archivist, mechanism and department doctor distribute permission, clinical test document management subsystem
Clinical testing data management module and clinical test application documents management module execute the typing of clinical testing data document,
It is secondary, the clinical testing data management module of clinical test document management subsystem by internet receive subject's related data and
Subject knows book, and data inputting is completed and after data submitter confirmation, and file joins confirmation unit and transfers to file raw data
At and profiling unit data are carried out to summarize arrangement, again, clinical test document coding subsystem is given according to archivist
The relevant classification of selecting file in mechanism/profession code mechanism of file content keyword, generate document classification list, and create
Build with the unique corresponding document identifier code of file, finally, document classification storage subsystem receives and stores the file after coding, Shen
The person of doing or school researcher, archivist, mechanism and department doctor can inquire the file of tape file identification code according to permission；
It requires the document expired to keeping to destroy according to file destruction in addition, file destroys application and confirmation unit, and indicates day
Phase, while the file in Destruction is submitted into clinical test document file management system.The technical solution is by using clinical test
Document coding, the storage of clinical test document classification are combined with clinical test document management, and document coding function therein can
Height is carried out with the phase characteristic of clinical test project data to be adapted to, realize clinical testing data and document effective position and
Inquiry, improves clinical test related personnel's document management efficiency, facilitates clinical test related personnel to clinical testing data
Arrangement classification is carried out, the intelligence degree of clinical testing data management is further improved, realizes clinical test related personnel
To managing on the efficient line of clinical testing data and document, it is tired to alleviate clinical testing data document query of the existing technology
Difficult technical problem.
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 kind of clinical test document file management system characterized by comprising clinical test document coding subsystem, clinical examination
Test document classification storage subsystem and clinical test document management subsystem；Wherein, the clinical test document management subsystem
For collecting the relevant document of clinical test and data, clinical test document, output end and clinical test document coding are generated
The input terminal of subsystem connects；The clinical test document coding subsystem uses mechanism/profession code mechanism, for document
Classified and works out corresponding unique document identifier code；The clinical test document classification storage subsystem is to having compiled
The document of code carries out classified and stored；
Wherein, the document coding subsystem includes document classification administrative unit and document identifier code creating unit；The file
Classification Management unit receives the clinical archive file tablet menu and clinical test that clinical test file generated and profiling unit are sent
Put on record table, and the file content keyword given according to archivist selecting file in mechanism/profession code mechanism is related
Classification, generate document classification list；The file that the document identifier code creating unit is generated according to document classification administrative unit
Tabulation, and create with the unique corresponding document identifier code of file, this document identifier code is sent to sponsor or school grinds
The person of studying carefully, and record information is sent to archivist.
2. clinical test document file management system according to claim 1, which is characterized in that the relevant document of the clinical test
And data include the clinical test number during the clinical test application documents of sponsor or school researcher proposition, clinical test
Accordingly and subject data；The document classification storage subsystem includes mechanism document library unit and project document library unit；Institute
Stating project document library unit includes item data management module and data acquisition and management module.
3. clinical test document file management system according to claim 1, which is characterized in that clinical test document management
System includes that clinical testing data submits unit, clinical test file handover confirmation unit, clinical test file generated and filing
Unit and clinical test file destroy application and confirmation unit；The clinical testing data submit unit for receive sponsor or
The clinical testing data that school researcher provides, and enabling signal to file is sent by its output end and joins confirmation unit；It is described
Clinical test file joins confirmation unit and sends notice to sponsor or institute by page end or user terminal according to enabling signal
Fang researcher confirms the clinical testing data of submission by sponsor or school researcher；The clinical test file is raw
At and profiling unit the clinical testing data after confirmation is carried out to summarize arrangement, generate and send clinical archive file tablet menu and
Clinical test is put on record table, the output end and clinical test document coding subsystem of the clinical test file generated and profiling unit
Connection.
4. clinical test document file management system according to claim 2, which is characterized in that the data submit unit include by
Examination person's data management module, clinical testing data management module and clinical test application documents management module；Subject data pipe
During the subject data in reason module includes the physical data of subject, physico-chemical examination data, clinical test
Research medical record data, the basic condition and record of case report form (Case Report Form, CRF) data and subject
Card data；Clinical testing data in the clinical testing data management module includes the clinical test knot during clinical test
Fruit data and standard parameter data；Clinical test application documents in the clinical test application documents management module include bidding to host
The term of reference number about drug test during clinical test application document, clinical test that person or school researcher propose
According to, risk profile assessment data and prediction of result data.
5. clinical test document file management system according to claim 3, which is characterized in that the file destroys application and confirmation
Unit is used for after the destruction application that receiving archives administrator proposes, sponsor or school are sent by way of mail or short message
The file content and carry out Electronic Signature confirmation that researcher is destroyed, are confirmed after destruction feedback, expire to keeping
Document destroyed.
6. clinical test document file management system according to claim 1, which is characterized in that the mechanism/profession code mechanism
Including organization's class document and pilot project class document；
Organization's class document includes: system functions catalogue, emergency preplan catalogue and standard practice instructions catalogue；
The pilot project class document includes: experimental study team catalogue, clinical test preparation stage catalogue, clinical test progress
Catalogue and clinical test other catalogues after the completion of stage catalogue, clinical test.
7. clinical test document file management system according to claim 1, which is characterized in that wrapped in the document classification list
It includes: classification sequence number, file class title, classification coding and parent coding.
8. a kind of clinical test document management method, it is characterised in that the following steps are included:
(1) clinical test document file management system distributes sponsor, school researcher, archivist, mechanism and department doctor
Permission, system are declared file, managed and are consulted according to Permission Levels；
(2) data of clinical test document management subsystem submit the clinical test application documents management module in unit to receive Shen
The application for the clinical test related data typing that the person of doing or school researcher submit, after application passes through, clinical testing data management
Module and clinical test application documents management module execute data inputting, and transfer to archivist to examine the data of typing
Core；
(3) the clinical testing data management module of clinical test document management subsystem by internet receive department doctor to by
The related data that examination person carries out a medical examination with physico-chemical examination, subject data management module records subject related data and by
Examination person knows book, and sponsor or school researcher, supervisor and archivist can inquire data；
(4) after the completion of data inputting, the short message or mail that confirmation is submitted are issued by file handover confirmation unit, in data submitter
After confirmation, file joins confirmation unit and data is transferred to file generated and profiling unit, and file generated and profiling unit are to data
It carries out summarizing arrangement, generates and sends archive file and clinical test is put on record table, and be sent to archivist's confirmation；
(5) clinical test document coding subsystem receives the archive file after confirmation, document classification administrative unit by internet
It receives clinical archive file tablet menu that clinical test file generated and profiling unit are sent and clinical test is put on record table, and according to
The file content keyword that archivist gives relevant classification of selecting file in mechanism/profession code mechanism generates text
Part tabulation；The document identifier code creating unit receives the document classification list that document classification administrative unit generates, and creates
Build with the unique corresponding document identifier code of file, this document identifier code is sent to sponsor or school researcher, and will put on record
Information is sent to archivist；
(6) document classification storage subsystem receives and stores the file after coding, sponsor or school researcher, file administration
Member, mechanism and department doctor can inquire the file of tape file identification code according to permission；
(7) file destroys application and confirmation unit, after the destruction application that receiving archives administrator proposes, passes through mail or short message
Mode send file content that sponsor or school researcher are destroyed and carry out Electronic Signature confirmation；It is confirmed pin
It ruins after feedback, is destroyed according to file and the document expired to keeping is required to destroy, and dated, while by Destruction
In file submit clinical test document file management system.
9. clinical test document management method according to claim 8, which is characterized in that the clinical test file handover is true
Recognize unit and also receive the unloading application of the expired file without destroying, and receives the essential information of third party's file management mechanism,
Waiting system confirmation；After completing confirmation, the expired file that need to be destroyed is sent to third party's file management mechanism keeping archives text
Part is performed simultaneously unloading signature confirmation, and records the unloading date；Meanwhile the record file in unloading handshaking being committed to
The mechanism document library unit of clinical test document classification storage subsystem.
10. clinical test document management method according to claim 8, which is characterized in that further include being ground with sponsor, school
The electronic signature of the person of studying carefully, archivist and department doctor docking confirm subsystem, after operator executes operation, electronics label
Name confirmation subsystem carries out electronic signature confirmation；It is described to sign electronically to be fingerprinting operation, face recognition operation, iris recognition behaviour
Make or stamped signature operates.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811590712.8A CN109817291B (en) | 2018-12-25 | 2018-12-25 | Clinical trial document management system and management method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811590712.8A CN109817291B (en) | 2018-12-25 | 2018-12-25 | Clinical trial document management system and management method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109817291A true CN109817291A (en) | 2019-05-28 |
| CN109817291B CN109817291B (en) | 2023-01-10 |
Family
ID=66602360
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811590712.8A Active CN109817291B (en) | 2018-12-25 | 2018-12-25 | Clinical trial document management system and management method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109817291B (en) |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110309384A (en) * | 2019-07-08 | 2019-10-08 | 南京楚卿电子科技有限公司 | A kind of management method carrying out patent document classification using the date |
| CN110379472A (en) * | 2019-07-23 | 2019-10-25 | 上海交通大学医学院附属第九人民医院 | A kind of clinical research project management system |
| CN110472831A (en) * | 2019-07-13 | 2019-11-19 | 魏文龙 | A kind of management software system |
| CN111028910A (en) * | 2019-12-10 | 2020-04-17 | 嘉兴太美医疗科技有限公司 | Random and drug delivery execution method, system and readable medium for random and drug delivery system |
| CN111695131A (en) * | 2020-06-23 | 2020-09-22 | 上海用正医药科技有限公司 | Document management method and system for clinical trial |
| CN111913673A (en) * | 2020-07-28 | 2020-11-10 | 立讯智造(浙江)有限公司 | Method, device and equipment for managing controlled files |
| CN111916161A (en) * | 2020-06-23 | 2020-11-10 | 上海用正医药科技有限公司 | Method and device for collecting and converting multiple data sources in clinical test process |
| CN112395255A (en) * | 2019-08-13 | 2021-02-23 | 神讯电脑(昆山)有限公司 | Test file management system |
| CN112416939A (en) * | 2020-11-27 | 2021-02-26 | 上海妙一生物科技有限公司 | Screening method and device for clinical research center |
| CN113053478A (en) * | 2021-03-11 | 2021-06-29 | 上海交通大学医学院附属新华医院 | Project and quality control system suitable for clinical test of medicine |
| CN113674818A (en) * | 2021-08-23 | 2021-11-19 | 苏州优炫智能科技有限公司 | Management method and management system for main documents of medical electronic tests |
| CN114064568A (en) * | 2021-11-11 | 2022-02-18 | 江下信息科技(惠州)有限公司 | Collaborative document management service method and system |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101452503A (en) * | 2008-11-28 | 2009-06-10 | 上海生物信息技术研究中心 | Isomerization clinical medical information shared system and method |
| US20120060216A1 (en) * | 2010-09-01 | 2012-03-08 | Apixio, Inc. | Medical information navigation engine (mine) system |
| CN102414688A (en) * | 2009-04-30 | 2012-04-11 | 汤姆科技成像系统有限公司 | Method and system for managing and displaying medical data |
| CN103577766A (en) * | 2012-08-09 | 2014-02-12 | 董靖 | Safety management method and safety management system for electronic file |
| CN107247864A (en) * | 2017-04-18 | 2017-10-13 | 上海交通大学附属第六人民医院 | Clinical drug trials and subject's management system and method |
| CN107506366A (en) * | 2017-06-27 | 2017-12-22 | 北京明朝万达科技股份有限公司 | A kind of document life management method and system based on globally unique ID |
| CN107657986A (en) * | 2017-09-22 | 2018-02-02 | 中链科技有限公司 | Clinical testing data check method, system and electronic equipment |
| CN108877904A (en) * | 2018-06-06 | 2018-11-23 | 天津阿贝斯努科技有限公司 | A kind of clinical trial information's cloud platform and clinical trial information's cloud management method |
-
2018
- 2018-12-25 CN CN201811590712.8A patent/CN109817291B/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101452503A (en) * | 2008-11-28 | 2009-06-10 | 上海生物信息技术研究中心 | Isomerization clinical medical information shared system and method |
| CN102414688A (en) * | 2009-04-30 | 2012-04-11 | 汤姆科技成像系统有限公司 | Method and system for managing and displaying medical data |
| US20120060216A1 (en) * | 2010-09-01 | 2012-03-08 | Apixio, Inc. | Medical information navigation engine (mine) system |
| CN103577766A (en) * | 2012-08-09 | 2014-02-12 | 董靖 | Safety management method and safety management system for electronic file |
| CN107247864A (en) * | 2017-04-18 | 2017-10-13 | 上海交通大学附属第六人民医院 | Clinical drug trials and subject's management system and method |
| CN107506366A (en) * | 2017-06-27 | 2017-12-22 | 北京明朝万达科技股份有限公司 | A kind of document life management method and system based on globally unique ID |
| CN107657986A (en) * | 2017-09-22 | 2018-02-02 | 中链科技有限公司 | Clinical testing data check method, system and electronic equipment |
| CN108877904A (en) * | 2018-06-06 | 2018-11-23 | 天津阿贝斯努科技有限公司 | A kind of clinical trial information's cloud platform and clinical trial information's cloud management method |
Non-Patent Citations (3)
| Title |
|---|
| 丁倩，等: "基于药物临床试验质量控制的文档管理规范化探讨", 《药物评价研究》 * |
| 李彻，等: "临床试验质控数字化建设", 《中国新药与临床杂志》 * |
| 汶柯，等: "基于风险的药物临床试验机构文档规范化管理探讨", 《2018 年中国药学会药物临床评价研究专业委员会学术年会暨临床研究高峰论坛会议论文集》 * |
Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110309384A (en) * | 2019-07-08 | 2019-10-08 | 南京楚卿电子科技有限公司 | A kind of management method carrying out patent document classification using the date |
| CN110472831A (en) * | 2019-07-13 | 2019-11-19 | 魏文龙 | A kind of management software system |
| CN110379472A (en) * | 2019-07-23 | 2019-10-25 | 上海交通大学医学院附属第九人民医院 | A kind of clinical research project management system |
| CN112395255A (en) * | 2019-08-13 | 2021-02-23 | 神讯电脑(昆山)有限公司 | Test file management system |
| CN111028910A (en) * | 2019-12-10 | 2020-04-17 | 嘉兴太美医疗科技有限公司 | Random and drug delivery execution method, system and readable medium for random and drug delivery system |
| CN111028910B (en) * | 2019-12-10 | 2024-01-23 | 上海亿锎智能科技有限公司 | Random and dispensing execution method, system and readable medium for random and pharmaceutical system |
| CN113806292A (en) * | 2020-06-23 | 2021-12-17 | 上海用正医药科技有限公司 | Document management method and system for clinical trial |
| CN111695131A (en) * | 2020-06-23 | 2020-09-22 | 上海用正医药科技有限公司 | Document management method and system for clinical trial |
| CN111916161A (en) * | 2020-06-23 | 2020-11-10 | 上海用正医药科技有限公司 | Method and device for collecting and converting multiple data sources in clinical test process |
| CN111695131B (en) * | 2020-06-23 | 2021-04-02 | 上海用正医药科技有限公司 | Document management method and system for clinical trial |
| CN111916161B (en) * | 2020-06-23 | 2021-04-16 | 上海用正医药科技有限公司 | Method and device for collecting and converting multiple data sources in clinical test process |
| CN111913673A (en) * | 2020-07-28 | 2020-11-10 | 立讯智造(浙江)有限公司 | Method, device and equipment for managing controlled files |
| CN112416939A (en) * | 2020-11-27 | 2021-02-26 | 上海妙一生物科技有限公司 | Screening method and device for clinical research center |
| CN113053478A (en) * | 2021-03-11 | 2021-06-29 | 上海交通大学医学院附属新华医院 | Project and quality control system suitable for clinical test of medicine |
| CN113674818A (en) * | 2021-08-23 | 2021-11-19 | 苏州优炫智能科技有限公司 | Management method and management system for main documents of medical electronic tests |
| CN114064568A (en) * | 2021-11-11 | 2022-02-18 | 江下信息科技(惠州)有限公司 | Collaborative document management service method and system |
Also Published As
| Publication number | Publication date |
|---|---|
| CN109817291B (en) | 2023-01-10 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN109817291A (en) | Clinical test document file management system and management method | |
| Bradley et al. | Health services research and data linkages: issues, methods, and directions for the future | |
| Hoerbst et al. | Electronic health records | |
| US8595028B2 (en) | System and method for performing medical research across a vast patient population | |
| US20120173289A1 (en) | System and method for detecting and identifying patterns in insurance claims | |
| CA2684241A1 (en) | Decision support response systems and methods | |
| CN115579117A (en) | Data assets system and method of medical data | |
| Sullivan | Making the business case for health and productivity management | |
| Madir | HealthTech: law and regulation | |
| Terry | Electronic health records: international, structural and legal perspectives | |
| Collen et al. | Multi-Hospital Information Systems (MHISs) | |
| Gilbert et al. | Health information work: A scoping review | |
| CN112259184A (en) | Rehabilitation diagnosis and treatment data report generation method | |
| Song | University Counterpart Support Information Management System Based on Artificial Intelligence Technology | |
| Hughes et al. | The significance of data harmonization for credentialing research | |
| Kalaiselvi et al. | Big data analytics and intelligence: A perspective for health care | |
| Zhang et al. | Intelligent Medical Insurance Supervision System | |
| Tolmie et al. | Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial | |
| Nelson | Stepping into Continuous Audit: a health-care audit shop shares its strategy for making real-time auditing a success | |
| Sui et al. | The effect of smart campus on the low infection rate in the post-pandemic era | |
| Khuntia et al. | Information management and information services in Health Science Libraries: An overview | |
| CN112289421A (en) | Clinical scientific research system suitable for hospital | |
| Liu | Design and Implementation of Health Management Information System | |
| Uwaifo et al. | Records Management Systems in University Health Centres in State Universities in Bayelsa State, Nigeria | |
| US20180247702A1 (en) | Secure, accurate, and efficient patient intake systems and methods |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP03 | Change of name, title or address |
Address after: Floor 6, Block A, No. 1, Haitai Fazhan Er Road, Huayuan Industrial Zone, Binhai New Area, Tianjin, 300392 Patentee after: Tianjin Beiken Medical Technology Co.,Ltd. Address before: 300457 Floor 6, Building A, No. 1, Haitai Development Second Road, Huayuan Industrial Zone, High tech Zone, Binhai New Area, Tianjin Patentee before: TIANJIN ABEISINU TECHNOLOGY CO.,LTD. |
|
| CP03 | Change of name, title or address | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20231114 Address after: Building 3, Tianjin Science and Technology Plaza, Science and Technology West Road, Nankai District, Tianjin, 300000, 0656 (Tiankai Park) Patentee after: Dongtai Medical Technology (Tianjin) Co.,Ltd. Address before: Floor 6, Block A, No. 1, Haitai Fazhan Er Road, Huayuan Industrial Zone, Binhai New Area, Tianjin, 300392 Patentee before: Tianjin Beiken Medical Technology Co.,Ltd. |
|
| TR01 | Transfer of patent right |