One clinical trial phase management system and management methodTechnical field
The present invention relates to clinical testing data supervision and management technical fields, more particularly, to an a kind of clinical trial phase managementSystem 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, andIts subject is mostly healthy population.To guarantee that Phase I clinical trial real result is reliable, Phase I clinical trial quality management is adapted toIt 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 yearAdd.Phase I clinical trial, especially new medicine and imitation medicine Phase I clinical trial quantity rapid growth, test China I phase totalAbility of immigrants and management level are put forward higher requirements.For drug I phase experimental design and the complexity of implementation and innovative, formulationCorresponding guideline, to improve the science of I phase experimental design, the reasonability of ethics, the normalization of implementation, guidance new drug is groundHair develops rapidly and healthily.In China, medicament research and development reaches under international requirement, under the background of new drug development globalization, isChina'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 showOn some clinical test lines management system be difficult to be managed according to Phase I clinical trial feature structure and data file interaction intoRow 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 alleviateDifficult 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 commentedExamine subsystem；Wherein, work station subsystem respectively with subject data management subsystem, I phase experimental study room management subsystemBi-directional data connection is carried out between pilot project management subsystem；Pilot project management subsystem and Ethics Committee's evaluationSystem 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, submitsThe 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 generationThe 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 itemMesh data information chooses researcher, is simultaneously emitted by Item announcements to the researcher chosen；The phase experimental study room I manages subsystemSystem also generates and output test facility information and test site information, and by project initiation situation and arranges to carry out with document formIt 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 equipmentIt 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 informationProject 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 sentTo 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 protectedIt 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 subsystemSystem includes that subject enters a group data cell, checks data cell, test data unit, case report form generation unit and doctor's advice reportAccuse 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 submissionShape code；Check that data cell is made of physical data module and physico-chemical examination data module, for tested to being recruitedPerson carries out a medical examination with physico-chemical examination and generation is recruited the inspection result data of subject；Inspection result data includes physiqueCheck data and physico-chemical examination data；Subject enters group data cell and obtains inspection result data, and the data are comparedScreening, selection is satisfactory to be recruited subject as subject, and the selection result is sent to and is recruited subject, simultaneouslyThe 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 numberAccording to management module and adverse events generate and reminding module, for tracking the clinical test process of subject and recording clinical testData；
Case report form generation unit is corresponding with the ID bar code of subject according to clinical testing data and doctor's advice report generationCase 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 includesDatabase 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 itemThe project data information that mesh management subsystem is sent generates project item, and project item is according to the project in project data informationThe 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 userFixed 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 respectivelyExisting data interaction.
Further, in clinical trial phase management system provided in an embodiment of the present invention, system transaction management unit packetIt includes work calendaring module and project process logging modle connected to it, outstanding work reminding module and critical event reminds mouldBlock；
Project process logging modle, outstanding work reminding module and critical event reminding module also manage son with pilot project respectivelySystem connection；
Project process logging modle is used to generate project process item according to project data information；Outstanding work reminding module and againWant event reminding module for generating project process item according to project data information；Critical event reminding module is used for according to itemMesh 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 ISubsystem include testing crew information management module, test site management module, testing equipment management module and document formulate andPreserving 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 crewResearcher is chosen in breath management module, and researcher's information of selection is carried out in real time in document formulation and preserving moduleRecord saves；
Testing equipment management module generates testing equipment information according to project data information configuration testing equipment, and test is setStandby 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 siteGround 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 subsystemIncluding 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 relationsThe 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 bearThe 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, togetherWhen 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 subsystemSystem, 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 simultaneouslyThe information of output test facility information and test site, and by project initiation situation and arrange to save with document form to textIn shelves formulation and preserving module；And researcher is chosen according to project data information, while issuing to the researcher of selectionItem 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 informationIt takes clinical medicine information and is deposited into drug maintenance module, subject recruitment information issuing module combination clinical medicine letterBreath 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 byExamination 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 submissionBar code checks that data cell carries out a medical examination and physico-chemical examination to being recruited subject, and generates and be recruited subject'sInspection result data；Subject enters a group data cell and obtains and save inspection result data, and screening, root is compared to the dataAccording to check data standard choose it is satisfactory be recruited subject as subject, and the selection result is sent to be recruited byExamination 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 subjectIt 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 peopleMember 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 recordsClinical testing data updates the real-time record of result progress of being hospitalized and observe of subject, while generating and recording clinical test numberAccording 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 subjectThe 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 testedResearch 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 crewResearcher is chosen in breath management module；Testing equipment management module generates examination according to project data information configuration testing equipmentTest 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 subsystemInformation generates project item, and project item includes work calendar, project process record and outstanding work, and to outstanding work andCritical event is reminded；User sets transaction management unit reception researcher and passes through user terminal according to the development of projects situationWork 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 stepsRecord 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 inventionSystem and management method, including work station subsystem, subject data management subsystem, I phase experimental study room management subsystem, examinationTest project management subsystem and Ethics Committee's evaluation subsystem；Wherein, work station subsystem respectively with subject data managementBi-directional data connection is carried out between subsystem, I phase experimental study room management subsystem and pilot project management subsystem；Test itemMesh management subsystem is connect with Ethics Committee's evaluation subsystem.The technical solution by using work station subsystem respectively and respectivelyA functional subsystem carries out data docking, has adjusted data management structure for Phase I clinical trial feature and data file is handed overClinical test project is combined with subject data and research department's management respectively, realizes clinical test project by mutual modeApplication approval, the equipment use of clinical experimental study room and personal scheduling and the screening of clinical test subject, notice sum numberAccording to preservation, and then the unification dynamic information system management online of Phase I clinical trial is realized, improves clinical trial management effectRate, meanwhile, which provides item for manager and reminds, and further improves user experience, improves the efficiency of management, alleviatesThe 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 cooperateAppended 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 artEmbodiment 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 inventionSchematic 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 inventionStructure 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 shownIt 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 inventionTechnical solution be clearly and completely described, based on the embodiments of the present invention, those of ordinary skill in the art are not doingEvery 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 subjectMostly 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 toSubjects interest and safety need the management system for being suitble to Phase I clinical trial laboratory feature.Secondly, in recent years in order to meetThe 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 lineSystem 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 inventionThe clinical trial phase management system and management method that embodiment provides, may be implemented Phase I clinical trial information system management, improveClinical trial management efficiency, compensates for the blank of the prior art, by means of the management system of database technology, assists phase realRoom 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 mentionsThe clinical trial phase management system supplied, including work station subsystem, subject data management subsystem, I phase experimental study roomManagement subsystem, pilot project management subsystem and Ethics Committee evaluate subsystem；Wherein, work station subsystem respectively with byTwo-way number is carried out between examination person's data administration subsystem, I phase experimental study room management subsystem and pilot project management subsystemAccording 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, generatingThe 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 subsystemResearcher is chosen according to project data information, is simultaneously emitted by Item announcements to the researcher chosen；The phase experimental study room I pipeReason subsystem also generates and output test facility information and test site information, and by project initiation situation and arranges with document shapeFormula 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 andPhysico-chemical examination data, and the selected subject for participating in clinical test of integration project data information, record the clinical test of subjectData 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 informationGeneration project item；It is set also according to received user and generates user's setting item, and project item and user are set into itemIt is sent to its corresponding terminal；And generation, the circulation of data, file before and after clinical test process are remembered in real timeRecord 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 dataThe structural schematic diagram of management subsystem.In clinical trial phase management system provided in an embodiment of the present invention, subject data pipeReason subsystem include subject enter a group data cell, check data cell, test data unit, case report form generation unit andDoctor'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 submissionPart 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 outPhysical examination and physico-chemical examination simultaneously generate the inspection result data for being recruited subject, wherein inspection result data includes physiqueCheck data and physico-chemical examination data；Subject enters group data cell and obtains inspection result data, and by the data in presetScreening is compared in the normal data of standard value range and the related drugs in project data information, chooses satisfactory quiltSubjects recruitment enters group as subject, and the selection result is sent to and is recruited subject, while this is recruited subjectAttribute be labeled as passing through into group, enter after group passes through, into the implementation phase of clinical test；Specifically, physical examination includes such asAge of subjects recruitment, weight (or BMI), is included in a series of/judgment criterias such as exclusion criteria at height；It is recruited subjectEnter 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 byExamination 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 bodyLattice check data and physico-chemical examination data, and in clinical test implementation phase, subject should be according to doctor's advice report executing clinical testProcess.Test data unit includes hospitalization data management module, administration data management module, blood sampling data management module, observationData management module and adverse events generation and reminding module, for tracking the implementation process and record of the clinical test of subjectClinical 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 advanceDesigned time point, data were automatically associated in CRF to subject's blood was collected operation.Data management module is observed in clinicThe 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 subjectThe status tracking of inspection through system, digestive system, bleeding and adverse events, and, subject's temperature pulse respiration is shunkThe 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 dataAnd 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 subjectThe case report form answered.
Further, referring to Fig. 3, in clinical trial phase management system provided in an embodiment of the present invention, workbench subsystemThe structural schematic diagram of system.In clinical trial phase management system provided in an embodiment of the present invention, work station subsystem includes centerDatabase Unit and system transaction management unit connected to it, user set transaction management unit and display unit.System thingItem administrative unit between central database unit and pilot project management subsystem by connecting, for according to project management subsystemThe project data information that system is sent generates project item, and project item is according to the item nodes creation in project data informationItem is reminded, and project item is sent to display unit progress item and is shown；Pending item, generation such as in workflowSerious adverse events are held notice of meeting, notice of meeting of project initiation meeting of project preparation meeting etc. and are reminded.User sets itemAdministrative unit also receives researcher and is set by the user that user terminal is submitted, and according to user's setting and project data informationIt 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, standbyForget, meeting schedule, the reminded contents such as reservation.Central database unit is also tried with subject data management subsystem and I phase respectivelyIt 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 phaseData 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 packetIt includes work calendaring module and project process logging modle connected to it, outstanding work reminding module and critical event reminds mouldBlock.Project process logging modle, outstanding work reminding module and critical event reminding module also manage son with pilot project respectivelySystem connection.Project process logging modle is used to generate project process item according to project data information；Outstanding work reminds mouldBlock and critical event reminding module are used to generate project process item according to project data information；Critical event reminding module is used forProject 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 phaseThe structural schematic diagram of room management subsystem.In clinical trial phase management system provided in an embodiment of the present invention, I phase experimental studyRoom management subsystem includes testing crew information management module, test site management module, testing equipment management module and documentIt formulates and preserving module, I phase experimental study room management subsystem obtains pilot project by central database unit and manage subsystemProject data information in system generates and issues Item announcements and information to clinical test related personnel.Testing crew message tubeModule 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 crewThe mode that long technical field matches chooses suitable researcher, and grinding selection in testing crew information management moduleStudy 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 dataInformation configuration testing equipment generates testing equipment information, and testing equipment information is carried out in document formulation and preserving moduleRecord saves in real time.Test site management module chooses test site according to project data information, generates test site information, andTest 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 pipeManage the structural schematic diagram of subsystem.In clinical trial phase management system provided in an embodiment of the present invention, pilot project managementSystem includes project release module, drug maintenance module and subject recruitment information issuing module.Project release module is according to ShenThe publication instruction publication item related information for the person of doing, and item related information is sent to Ethics Committee's evaluation subsystem to itemMesh carries out the assessment audit of ethics.Drug maintenance module extracts clinical medicine information according to item related information and is deposited intoIn 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 byThe 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 dataManagement 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 projectBi-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 clinicThe feature of testing has adjusted data management structure and data file interactive mode, by clinical test project respectively with subject data andResearch department's management combines, and the equipment of the application approval, clinical experimental study room that realize clinical test project uses and personnelScheduling and the screening of clinical test subject, notice and data save, and then the unification for realizing Phase I clinical trial is moved onlineThe information system management of state improves clinical trial management efficiency, meanwhile, which provides item for manager and reminds, furtherIt improves user experience, improve the efficiency of management, alleviate Phase I clinical trial information system management difficulty of the existing technologyTechnical 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 inventionOne 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 itemThe 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 ethicsExamination result feeds back typing to pilot project management subsystem, if Ethic review evaluation passes through, pilot project management subsystemItem 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 simultaneouslyThe information of output test facility information and test site, and by project initiation situation and arrange to save with document form to textIn shelves formulation and preserving module；And researcher is chosen according to project data information, while issuing to the researcher of selectionItem 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 informationItem related information, extract clinical medicine information simultaneously be deposited into drug maintenance module, subject recruitment information publicationModule combination clinical medicine information and project data information arrange the every inspection for the subject for being able to bear the project clinical testData 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 submissionBar code checks that data cell carries out a medical examination and physico-chemical examination to being recruited subject, and generates and be recruited subject'sInspection result data；Subject enters a group data cell and obtains and save inspection result data, and screening, root is compared to the dataAccording to check data standard choose it is satisfactory be recruited subject as subject, and the selection result is sent to be recruited byExamination 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 subjectIt 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 peopleMember verifies and confirms with clinician, doctor's advice information is compared in time during the test, by nurse's Dynamic Execution doctor's advicePoints for attention；
(7) enter the real-time observation stage of clinical test, test data unit tracks clinical test process to subject and recordsClinical testing data updates the real-time record of result progress of being hospitalized and observe of subject, while generating and recording clinical test numberAccording 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 timeThe case where subject takes drugs front and back is examined, main includes nervous system, digestive system, bleeding and the adverse events of subjectThe status tracking of inspection, and, the vital sign of subject's temperature pulse respiration, systolic pressure carries out above-mentioned data real-timeRecord 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 subjectThe 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 testedResearch 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 crewResearcher 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 mouldRoot tuber chooses test site according to project data information, generates test site information.Instrument & equipment management is responsible for by special messenger；Instrument is setStandby operator has appropriate qualification and passes through training on operation, uses equipment according to corresponding uses；Instrument and equipment has clearly labelIt indicates its date of manufacture and operating status, and is safeguarded, detected and calibrated；Instrument and equipment is advised with operable standard operationJourney, 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 withThe equipment with function is supported, such as ECG monitor, electrocardiograph, defibrillator and ventilator are monitored with vital sign, and is hadThere 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 prepareRoom, 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, toolIt is necessary to rescue, monitor equipment and common first-aid medicine, emergencycallboxsystem etc., it is ensured that subject is robbed in timeIt 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 subsystemInformation generates project item, and project item includes work calendar, project process record and outstanding work, and to outstanding work andCritical event is reminded；User sets transaction management unit reception researcher and passes through user terminal according to the development of projects situationWork plan, memorandum, meeting schedule and the reminded contents of reservation of typing generate user and set item.Wherein, subsystem is automaticThe project of login user is subjected to matching screening, shows Institutional Review situation, Ethic review result, project status, project and entersThe 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 workflowGood 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 meterIt 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 stepsRecord 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 defeatedEnter 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 projectMoral check examination is carried out to Ethics Committee's evaluation subsystem, after Ethic review evaluation passes through, pilot project management subsystem is thenItem 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 roomManagement subsystem generates and the information of output test facility information and test site, chooses research people according to project data informationMember notifies it to prepare clinical test；Pilot project management subsystem combination clinical medicine information and project data information, publication are facedBed test subject recruitment information；Then, subject enters group data cell and carries out a medical examination and physical and chemical to being recruited subjectIt checks, is recruited subject as subject according to checking that data standard selection is satisfactory, subject is notified to prepare to participate inClinical 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 examinationIt is reported at doctor's advice；Test data unit tracks clinical test process to subject and records clinical testing data, to subject'sIn 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 lifeAt case report form corresponding with the ID bar code of subject.The technical solution by using work station subsystem respectively and respectivelyA functional subsystem carries out data docking, has adjusted data management structure for Phase I clinical trial feature and data file is handed overClinical test project is combined with subject data and research department's management respectively, realizes clinical test project by mutual modeApplication approval, the equipment use of clinical experimental study room and personal scheduling and the screening of clinical test subject, notice sum numberAccording to preservation, and then the unification dynamic information system management online of Phase I clinical trial is realized, improves clinical trial management effectRate, meanwhile, which provides item for manager and reminds, and further improves user experience, improves the efficiency of management, alleviatesThe 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 inventionTechnical 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 hairIt is bright to be described in detail, those skilled in the art should understand that: anyone skilled in the artIn the technical scope disclosed by the present invention, it can still modify to technical solution documented by previous embodiment or can be lightIt is readily conceivable that variation or equivalent replacement of some of the technical features；And these modifications, variation or replacement, do not makeThe 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 inventionWithin the scope of.Therefore, protection scope of the present invention should be based on the protection scope of the described claims.