CN109616190A - Center Ethic review management system and management method - Google Patents
Center Ethic review management system and management method Download PDFInfo
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- CN109616190A CN109616190A CN201811589676.3A CN201811589676A CN109616190A CN 109616190 A CN109616190 A CN 109616190A CN 201811589676 A CN201811589676 A CN 201811589676A CN 109616190 A CN109616190 A CN 109616190A
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Abstract
The present invention provides center Ethic review management system and management methods, it is related to clinical test Ethic review administrative skill field, comprising: centre management subsystem, Ethics Committee's information bank subsystem, ethics experts database subsystem, project management subsystem, clinical test project examine applications management subsystem and evaluate management subsystem.The clinical test project of project management subsystem typing and be committed to clinical test project examine applications management subsystem confirmed, Ethics Committee's information bank subsystem establishes Ethics Committee, ethics experts database subsystem selects ethics expert, it is center Ethics Committee that centre management subsystem, which is established, center Ethics Committee by evaluate management subsystem to clinical test project carry out examine appraise through discussion, ultimately generate examination and appraise result through discussion.It improves the fairness of clinical test Ethic review, science and improves work efficiency, the technical problem that the fairness for alleviating Ethic review of the existing technology is poor, checking process tracking is difficult.
Description
Technical field
The present invention relates to clinical test Ethic review administrative skill fields, more particularly, to a kind of center Ethic review management
System and management method.
Background technique
With the high speed development of modern medicine study, multi-center clinical trial has been increasingly becoming a kind of trend.Currently, in mostly
Heart clinical test participant Ethic review is primarily present following several situations: 1) part participant in multi-center clinical trial
Ethics Committee be completely dependent on group leader's unit and implement Ethic review, participant directly puts on record, without examining；2) part is joined
No matter adding whether unit Ethics Committee group leader's unit examines, all implement Ethic review；3) part Ethics Committee is right
On the basis of group leader's unit Ethics Committee work quality carries out assessment approval, quickly examined.
But above-mentioned center Ethic review way to manage there is a problem of it is different degrees of, firstly, participant is not examined
It looks into and directly puts on record, examine that quality is irregular, be unable to ensure group leader's unit to the fairness, science and human relations of pilot project
Manage the reasonability examined；Secondly, each participant ethics committee member examines the same scheme, testing program can be proposed respectively
The different suggestion for revision of kind coordinates development clinical test to sponsor and brings challenges；Again, both cause need not for multiple Ethic review
The duplication of labour wanted also reduces the safety of subject information；Further, since between group leader's unit and each participant not
Have and reach an agreement and working procedure, not yet explicitly initial review and tracking examine that the responsibility between group leader's unit and participant is drawn
Point, thus it is difficult to realize the comprehensive initial review of carry out system for the pilot project carried out to each center and the overall process of coordination
Tracking examines.Therefore, the prior art technical problem that there are the fairness of Ethic review is poor, checking process tracking is difficult.
Summary of the invention
In view of this, the purpose of the present invention is to provide center Ethic review management system and management method, it is existing to alleviate
Difficult technical problem is queried with the presence of checking on the line of technology clinical testing data.
In a first aspect, the embodiment of the invention provides a kind of center Ethic review management system, including centre management subsystem
System, Ethics Committee's information bank subsystem, ethics experts database subsystem, project management subsystem, clinical test project examine Shen
Management subsystem and management subsystem please be evaluated；
Ethics Committee's information bank subsystem, ethics experts database subsystem, project management subsystem, clinical test project examine Shen
It management subsystem and management subsystem please be evaluated is connect respectively with centre management subsystem；Ethics experts database subsystem and clinical examination
Test project examine applications management subsystem respectively with evaluate management subsystem and connect, Ethics Committee's information bank subsystem and project
Management subsystem examines that applications management subsystem is connect with clinical test project respectively；
Ethics committee member's information that Ethics Committee information bank subsystem typing this field worker submits, and by ethics committee member's information
It stores to Ethics Committee's information bank；
Project management subsystem receives the clinical test project that sponsor or researcher submit, typing by centre management subsystem
Project data information；Project management subsystem is also used to the project information that sponsor once participated in or mainly studies in school's project
The inquiry for the project information that member participates in；
Clinical test project examines that applications management subsystem obtains the project data information of project management subsystem, according to item number
It is believed that breath carries out submission confirmation to the project of declaring, for confirming the record for declaring project submitted and inquiry, it will also examine and submit
As a result it records and issues, while will confirm that the project of declaring of submission is sent to the formal examination unit for evaluating management subsystem；Really
To recognize after submission, clinical test project examines that applications management subsystem also transfers project keyword in project data information, and
Project keyword is sent to Ethics Committee's information bank subsystem；
Ethics Committee's information bank subsystem is chosen in Ethics Committee's information bank according to the project keyword of acquisition and meets item
Ethics committee member's information of mesh field related request, and notify the corresponding composition of personnel Ethics Committee of ethics committee member's information, simultaneously
The result of selection is fed back into clinical test project and examines applications management subsystem；
Ethics experts database subsystem obtains ethics expert's recommendation list that Ethics Committee submits, note by centre management subsystem
The ethics expert info in ethics expert recommendation list is recorded, ethics experts database is formed, is selected at random in ethics experts database,
Generate ethics expert inventory；
Centre management subsystem obtains the project data information of project management subsystem, according to project data information and ethics committee member
Information, and ethics expert inventory is combined, center Ethics Committee is established, and send evaluation permission to center ethics committee member and lead to
Know；
It evaluates management subsystem acquisition clinical test project and examines that applications management subsystem confirms that submits declares project, and to item
Mesh examine and is appraised through discussion；It evaluates management subsystem and the notice of meeting of evaluation meeting is also sent to center Ethics Committee, finally
Transmission project examines the examination result appraised through discussion and ethics official written reply to sponsor or researcher.
Further, in Ethic review management system in center provided in an embodiment of the present invention, evaluating management subsystem includes
Formal examination unit, first trial unit and center Ethics Committee management of appraising unit；The input terminal reception of formal examination unit is faced
Bed pilot project examines the project of declaring of applications management subsystem confirmation submission, and transmission formal examination notifies to give center ethics committee member
Can secretary, and the formal examination opinion of recording secretary typing and as a result, formal examination result and formal examination opinion are sent out simultaneously
It send to sponsor or researcher；
After the input terminal of first trial unit receives the information of formal examination qualification, typing consultant expert and Ethics Committee committee member
Preliminary inquiry result and opinion, while preliminary inquiry result and opinion are sent to sponsor or researcher, are sent after qualified
Pass signal is to center Ethics Committee management of appraising unit；
Center Ethics Committee management of appraising unit evaluates clinical test project, and result and ethics official written reply are appraised in generation through discussion,
And notice is sent to sponsor or researcher.
Further, in Ethic review management system in center provided in an embodiment of the present invention, the evaluation of center Ethics Committee
Administrative unit includes Ethics Committee's appraisal meeting management information module, appraises ballot management module through discussion and appraise results management module through discussion；
Ethics Committee's appraisal meeting management information module for issuing conferencing information, and notify Ethics Committee, ethics expert and
Sponsor or researcher carry out record and file generated to the content during appraisal meeting and save；Appraise ballot management module through discussion
Voting results are evaluated on line for collecting ethics expert's Signature Confirmation, are summarized and are formed final appraises result through discussion；Appraise result through discussion
Management module receive appraise through discussion ballot management module send final result after, generate and send ethics official written reply, and notify sponsor
Or researcher signs for.
Further, in Ethic review management system in center provided in an embodiment of the present invention, evaluating management subsystem includes
Scheme modifying examines that unit, periodic review unit, serious adverse events examine unit, violate programme review unit, termination test
Examine that unit and concluding a research item examine unit；
Scheme modifying examines that unit is used to carry out Ethic review to modified clinical test project；
Periodic review unit is used to carry out tracking Ethic review to clinical test project according to time interval preset in unit；
Serious adverse events examine that unit is used for according to obtaining serious bad time report that sponsor or researcher provide to facing
Bed pilot project carries out tracking Ethic review；
Programme review unit is violated to be used for when there is non-compliance in the progress of clinical test project or violate scheme event, to clinic
Pilot project carries out Ethic review；
Termination test examines that unit is used for when clinical test project terminates in advance, carries out Ethic review to clinical test project；
Concluding a research item examines that unit is used for the clinical test project progress Ethic review for having applied for concluding.
Further, in Ethic review management system in center provided in an embodiment of the present invention, Ethics Committee's information bank packet
Include basic information unit (BIU), ethics committee member information unit, committee member's change record unit, Ethics Committee's training record unit and ethics
Organize document element；Wherein, basic information unit (BIU) is for storing Ethics Committee's title, ethics responsible person, ethics secretary, address
And telephone number；Ethics committee member's information unit for record ethics committee member name, gender, the date of birth, educational background, learn it is professional,
Major research field, history participate in project and training historical information；Committee member's changing unit be used for record change committee member name and
Committee member changes the time；Ethics Committee's training record unit was used for name, the training date, training contents for participating in training committee member
And training duration is managed；Ethics tissue document element is for establishing Ethics Committee's management system, Ethics Committee's standard
Operating process, emergency event prediction scheme and foregoing units data file generated.
Further, in Ethic review management system in center provided in an embodiment of the present invention, project management subsystem includes
Clinical drug trial project management unit, Medical Deuice Clinical Trial project management unit, kit clinical test project management
Unit and scientific research task project management unit, are respectively used to the pilot project management of different development test objects.
Further, in Ethic review management system in center provided in an embodiment of the present invention, clinical drug experimental project pipe
Manage unit, Medical Deuice Clinical Trial project management unit, kit clinical test project management unit and scientific research task project
It include establishment of item module and history item information management module in administrative unit；
Essential information, drug information and the inclusion criteria of subject, exclusion criteria in establishment of item module including pilot project
With exit standard, wherein drug information includes trial drug information and comparison medicine information；It is wrapped in history item information management module
Include the project information that Principal Investigator participates in the project information or school's project that sponsor once participated in；History item information
Data attribute in management module is read-only.
Further, in Ethic review management system in center provided in an embodiment of the present invention, clinical test project examines Shen
Please management subsystem include examine submit unit, examine data confirmation unit and examine submit results management unit；
It examines in the input terminal and project management subsystem of submitting unit and is connected between each establishment of item module, examine and submit list
Member obtains the project data information of project management subsystem；
Examination data confirmation unit is submitted according to sponsor and researcher in project management subsystem for sponsor or supervisor
Project data information confirmation submission is carried out to the project of declaring, will confirm that the project of declaring of submission be sent to examination submit result pipe
Reason unit is recorded and is inquired, while will confirm that the project of declaring of submission is sent to the formal examination list for evaluating management subsystem
Member starting, which examines, to be appraised through discussion；
Examine that submitting results management unit to send submits successful short message or mail to sponsor, researcher and supervisor；It examines
It submits results management unit that will also examine and submits result publication, and be used for supervisor and carry out result queries；
It examines and submits results management unit also after pilot project confirmation is submitted, project key is transferred in project data information
Word, and project keyword is sent to Ethics Committee's information bank subsystem.
Second aspect, the embodiment of the invention provides a kind of center Ethic review management methods, comprising the following steps:
(1) ethics committee member's information that Ethics Committee's information bank subsystem typing this field worker submits, and by ethics committee member
Information is stored to Ethics Committee's information bank；
(2) project management subsystem receives the clinical test project that sponsor or researcher submit by centre management subsystem,
Typing item number is it is believed that breath；Primary investigators participate in the project information or school's project once participated in for sponsor simultaneously
The inquiry of project information；
(3) clinical test project examines the item number that the examination of applications management subsystem submits unit to obtain project management subsystem
It is believed that breath, examines that data confirmation unit carries out confirmation submission to the project of declaring according to project data information, and will confirm that submission
The project of declaring is sent to examination and results management unit is submitted to be recorded and issued, while will confirm that the project of declaring of submission is sent
To the formal examination unit for evaluating management subsystem；
(4) after confirmation is submitted, clinical test project examines that applications management subsystem also transfers project in project data information
Keyword, and project keyword is sent to Ethics Committee's information bank subsystem；
(5) Ethics Committee's information bank subsystem chooses symbol according to the project keyword of acquisition in Ethics Committee's information bank
Ethics committee member's information of project fields related request is closed, and notifies the corresponding composition of personnel Ethics Committee of ethics committee member's information,
The result of selection is fed back into clinical test project simultaneously and examines applications management subsystem；
(6) ethics experts database subsystem obtains the ethics expert that Ethics Committee submits by centre management subsystem and recommends to arrange
Table records the ethics expert info in ethics expert recommendation list, forms ethics experts database, carries out in ethics experts database random
It selects, generates ethics expert inventory；
(7) centre management subsystem obtains the project data information of project management subsystem, according to project data information and ethics
Committee member's information, and combine ethics expert inventory, establishes center Ethics Committee, and to center ethics committee member send evaluation permission and
Notice；
(8) it evaluates management subsystem and obtains the project of declaring that clinical test project examines the confirmation submission of applications management subsystem, and
Project examine and is appraised through discussion；It evaluates management subsystem and the notice of meeting of evaluation meeting is also sent to center Ethics Committee,
Finally sending project examines the examination result appraised through discussion and ethics official written reply to sponsor or researcher.
Further, in Ethic review management method in center provided in an embodiment of the present invention, step (8) specifically includes as follows
Step:
(8.1) formal examination unit receives clinical test project and examines that applications management subsystem confirms the project of declaring submitted, hair
It send formal examination to notify to center Ethics Committee secretary, and the formal examination content of recording secretary typing, while form being examined
It comes to an end fruit and formal examination opinion is sent to sponsor or researcher；
(8.2) after formal examination is qualified, first trial unit carries out preliminary inquiry, is read in ethics experts database by first trial unit at this time
Ethics expert info selects consultant expert automatically, and sends preliminary inquiry permission to consultant expert and center Ethics Committee,
Preliminary inquiry is carried out to project, preliminary inquiry result and preliminary inquiry opinion are sent to sponsor or researcher；First trial is qualified
First trial is sent afterwards passes through information to center Ethics Committee management of appraising unit；
(8.3) Ethics Committee's appraisal meeting management information module publication ethics evaluation of center Ethics Committee management of appraising unit
The conferencing information of meeting, and notice of meeting is sent to center Ethics Committee sponsor, researcher, to the meeting during appraisal meeting
View content is recorded, committee paper generates and committee paper saves；
(8.4) project of application is introduced by sponsor or researcher, ethics expert passes through page end or application program pair
It is voted, and submits after Signature Confirmation and appraises ballot management module through discussion, is summarized to ballot situation by the module and is formed most
Terminate fruit；After appraising results management module through discussion and receiving the final result for appraising ballot management module transmission through discussion, then ethics official written reply is generated,
And sponsor or researcher is notified to get.
The embodiment of the present invention brings following the utility model has the advantages that center Ethic review management system provided by the embodiment of the present invention
System and management method, comprising: centre management subsystem, Ethics Committee's information bank subsystem, ethics experts database subsystem, project
Management subsystem, clinical test project examine applications management subsystem and evaluate management subsystem.Project management subsystem will be recorded
The clinical test project entered is committed to clinical test project and examines that applications management subsystem is confirmed, clinical test project examines
Applications management subsystem generates the keyword of confirmation project, and Ethics Committee's information bank subsystem establishes Ethics Committee's information
Library, and matched in Ethics Committee's information bank according to keyword and choose ethics committee member, establish Ethics Committee, Ethics Committee
Ethics expert recommendation list is submitted, ethics experts database subsystem selects ethics expert, central tube according to ethics expert's recommendation list
Ethics expert and ethics committee member are established as by reason subsystem for carrying out data interaction between subsystem connected to it
Heart Ethics Committee, center Ethics Committee by evaluate management subsystem to clinical test project carry out examine appraise through discussion, finally
It generates examination and appraises result through discussion.By using based on clinical test project data information, Ethics Committee believes the technical solution
The mode that breath library subsystem is combined with ethics experts database subsystem selects center Ethics Committee committee member, center ethics committee
Member can have final decision-making power, avoid center Ethics Committee and be made of fixed personnel and influence clinical test project appraisal
Scientific and fairness, and, unified clinical test project is repeatedly examined at the center Duo Jia for avoiding participation clinical test
It looks into, further improve the fairness of clinical test Ethic review, science and improves work efficiency, while realizing and facing
The information data of the examinations overall process of bed pilot project tracks, the fairness for alleviating Ethic review of the existing technology is poor,
The difficult technical problem of checking process tracking.
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 Ethic review management system in center provided in an embodiment of the present invention；
Fig. 2 is the structural schematic diagram of project management subsystem in Ethic review management system in center provided in an embodiment of the present invention；
Fig. 3 is in Ethic review management system in center provided in an embodiment of the present invention, and clinical test project examines applications management
The structural schematic diagram of system；
Fig. 4 is the structural representation of Ethics Committee's information bank in Ethic review management system in center provided in an embodiment of the present invention
Figure；
Fig. 5 is to evaluate the structural schematic diagram of management subsystem in Ethic review management system in center provided in an embodiment of the present invention；
Fig. 6 is the flow chart of Ethic review management method in center 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.
Existing clinical test Ethic review management examines that quality is irregular there are problems, it is difficult to guarantee clinical
Fairness, science and the reasonability that pilot project examines, each participant ethics committee member examines the same scheme, right
Testing program can propose a variety of different suggestions for revision, coordinate development clinical test to sponsor and bring challenges, multiple ethics is examined
Looking into both leads to the unnecessary duplication of labour, also reduces the safety of subject information, and existing clinical test project ethics
The segregation of duties of examination is fuzzy, it is difficult to realize the pilot project that each center is carried out the comprehensive initial review of carry out system and
The tracking control of full process of coordination examines, is based on this, center Ethic review management system and management method provided in an embodiment of the present invention,
Center Ethics Committee, which may be implemented, ensure that the scientific and just of clinical test project appraisal by on-fixed composition of personnel
Property, it ensure that the final decision-making power of center Ethics Committee to improve project examination and appraise efficiency through discussion, while realizing clinical examination
Test the information data tracking of the examination overall process of project.
Embodiment one:
Referring to Fig. 1, the structural schematic diagram of Ethic review management system in center provided in an embodiment of the present invention.The embodiment of the present invention mentions
The center Ethic review management system of confession, comprising: centre management subsystem, Ethics Committee's information bank subsystem, ethics expert
Library subsystem, project management subsystem, clinical test project examine applications management subsystem and evaluate management subsystem.Ethics committee
Member can information bank subsystem and ethics experts database subsystem mainly in combination with being realized by means of database and Internet technology
The science of heart Ethics Committee committee member is chosen, subjective factor of effective reduction clinical test project during Ethic review
Guiding performance, to reduce the adverse effect caused by examination result.
Ethics Committee's information bank subsystem in the technical solution, project management subsystem, faces ethics experts database subsystem
Bed pilot project examines applications management subsystem and evaluates management subsystem and connect respectively with centre management subsystem；Ethics expert
Library subsystem and clinical test project examine applications management subsystem respectively with evaluate management subsystem and connect, Ethics Committee believes
Breath library subsystem and project management subsystem examine that applications management subsystem is connect with clinical test project respectively.
Project management subsystem receives the clinical test project that sponsor or researcher submit by centre management subsystem
Application, while the project data information of the typing clinical test project.Project management subsystem sends project data information
Examine that applications management subsystem carries out the submission confirmation of project application to clinical test project；Project management subsystem is also used to Shen
The inquiry for the project information that primary investigators participate in the project information or school's project that the person of doing once participated in.
Referring to fig. 2, in Ethic review management system in center provided in an embodiment of the present invention, the structure of project management subsystem
Schematic diagram.Further, in Ethic review management system in center provided in an embodiment of the present invention, project management subsystem includes medicine
Object clinical test project management unit, Medical Deuice Clinical Trial project management unit, kit clinical test project management list
Member and scientific research task project management unit, are respectively used to the pilot project management of different development test objects.Specifically, of the invention
In the center Ethic review management system that embodiment provides, clinical drug experimental project administrative unit, Medical Deuice Clinical Trial
It include establishment of item in project management unit, kit clinical test project management unit and scientific research task project management unit
Module and history item information management module.Specifically, essential information, drug letter in establishment of item module including pilot project
Breath and the inclusion criteria of subject, exclusion criteria and exit standard, wherein drug information includes trial drug information and comparison medicine
Information；People is mainly studied in the project information or school's project once participated in history item information management module including sponsor
The project information that member participates in；Data attribute in history item information management module is read-only.
Clinical test project examines that applications management subsystem obtains the project data information of project management subsystem, according to item
Mesh data information carries out submission confirmation to the project of declaring, which is also used to confirm the record for declaring project of submission and looks into
It askes, also the submission result of examination is recorded and issued, while will confirm that the project of declaring of submission is sent to and evaluating management subsystem
Formal examination unit further examined；After the confirmation of clinical test project is submitted, clinical test project examines application
Management subsystem chooses main study subject and the master of the high frequency words, project that occur in the contents of a project also in project data information
It wants research method as project keyword, and project keyword is sent to Ethics Committee's information bank subsystem.
Referring to Fig. 3, in Ethic review management system in center provided in an embodiment of the present invention, clinical test project examines application
The structural schematic diagram of management subsystem.Further, clinical in Ethic review management system in center provided in an embodiment of the present invention
Pilot project examines that applications management subsystem includes examining submit unit, examine data confirmation unit and examine and submit results management
Unit.Wherein, it examines in the input terminal and project management subsystem of submitting unit and is connected between each establishment of item module, obtained
Project data information in project management subsystem.Examination data confirmation unit for sponsor or supervisor according to sponsor and
Researcher carries out confirmation submission in the project data information that project management subsystem is submitted, and will confirm that submission declares project transmission
It submits results management unit to be recorded and inquired to examining, while will confirm that the project of declaring of submission is sent to and evaluating management
The formal examination unit starting examination of system is appraised through discussion.Examine submit results management unit send submit successful short message or mail to
Sponsor, researcher and supervisor；It will also examine simultaneously and submit result publication, and provided to supervisor and submit result queries.It examines
It looks into and results management unit is submitted also after pilot project confirmation is submitted, to choose in the contents of a project and occur in project data information
High frequency words, project main study subject and main approaches be sent to as project keyword, and by project keyword
Ethics Committee's information bank subsystem.
Ethics committee member's information that Ethics Committee information bank subsystem typing this field worker submits, and by ethics committee member
Information is stored to Ethics Committee's information bank.Ethics Committee's information bank subsystem also according to acquisition project keyword, by item
Keyword in mesh keyword and Ethics Committee's information bank in the Major research field of ethics committee member or the project mainly participated in
Match, the ethics committee member's information for meeting the correlation requirement of project fields is chosen in Ethics Committee's information bank, and notify
The corresponding composition of personnel Ethics Committee of ethics committee member's information, while the result that ethics committee member chooses is fed back into clinical test item
Mesh examines applications management subsystem.
Referring to fig. 4, in Ethic review management system in center provided in an embodiment of the present invention, the knot of Ethics Committee's information bank
Structure schematic diagram.Further, in Ethic review management system in center provided in an embodiment of the present invention, Ethics Committee's information bank packet
Include basic information unit (BIU), ethics committee member information unit, committee member's change record unit, Ethics Committee's training record unit and ethics
Organize document element；Wherein, basic information unit (BIU) for typing storage Ethics Committee's title, ethics responsible person, ethics secretary,
Address and telephone number；Ethics committee member's information unit is for recording ethics committee member name, gender, the date of birth, educational background, learning specially
Industry, Major research field, history participate in project and training historical information；Committee member's changing unit is used to record the name of change committee member
And committee member changes the time；Ethics Committee's training record unit is used for participating in the name of training committee member, training date, in training
Hold and training duration is managed；Ethics tissue document element is for establishing Ethics Committee's management system, Ethics Committee's mark
Quasi- operating process, emergency event prediction scheme and basic information unit (BIU) above-mentioned, ethics committee member information unit, committee member's change record list
Member and Ethics Committee's training record unit data file generated.
Ethics committee member submits ethics expert recommendation list by centre management subsystem, and ethics experts database subsystem obtains the ethics
Expert's recommendation list is stored with the ethics expert info of recommended ethics expert, ethics expert letter in ethics expert's recommendation list
Breath includes the essential information and Major research field of the expert, and ethics experts database subsystem is by the human relations in ethics expert's recommendation list
Reason expert info is established as ethics experts database, and is selected at random in ethics experts database, by the ethics expert's selected
Ethics expert info, which aggregates, is generated as ethics expert's inventory.
Centre management subsystem obtains the project data information of project management subsystem, according to project data information and ethics
Ethics committee member's information in committee's information bank subsystem, and ethics expert's inventory in ethics experts database subsystem is combined, it is comprehensive
It closes to arrange and establishes center Ethics Committee, and send evaluation permission and evaluation notice to the member of center Ethics Committee.Center
There is clinical test project to examine the final decision-making power appraised through discussion for Ethics Committee, so that the clinical test project center, to mention
Efficiency is appraised in high project examination through discussion.
It evaluates management subsystem and obtains the project of declaring that clinical test project examines the confirmation submission of applications management subsystem, and
Moral check examination is carried out to project to appraise through discussion；It evaluates management subsystem and the notice of meeting of evaluation meeting is also sent to center ethics committee
Member's meeting, it is ensured that the schedule of center Ethics Committee committee member acquisition Ethic review meeting；It finally sends project and examines the examination appraised through discussion
As a result with ethics official written reply to sponsor or researcher.Referring to Fig. 5, Ethic review management system in center provided in an embodiment of the present invention
In, evaluate the structural schematic diagram of management subsystem.Further, Ethic review management system in center provided in an embodiment of the present invention
In, evaluating management subsystem includes formal examination unit, first trial unit and center Ethics Committee management of appraising unit；Form is examined
The input terminal of verification certificate member receives the project of declaring that clinical test project examines the confirmation submission of applications management subsystem, and transmission form is examined
Notice is looked into center Ethics Committee secretary, and the formal examination opinion of recording secretary typing and as a result, by formal examination result
It is sent to first trial unit with formal examination opinion, while formal examination result and formal examination opinion are sent to sponsor or ground
The person of studying carefully.
The input terminal of first trial unit is connect with formal examination unit, and after the information for receiving formal examination qualification, typing is consulted
The preliminary inquiry result and opinion of expert and Ethics Committee committee member are ask, while preliminary inquiry result and opinion are sent to Shen
The person of doing or researcher send pass signal to center Ethics Committee management of appraising unit after qualified；
Center Ethics Committee management of appraising unit comments clinical test project after receiving the successful signal of first trial
It examines, result and ethics official written reply are appraised in generation through discussion, and the result notice of Ethic review is sent to sponsor or researcher.
Further, in Ethic review management system in center provided in an embodiment of the present invention, the evaluation of center Ethics Committee
Administrative unit includes Ethics Committee's appraisal meeting management information module, appraises ballot management module through discussion and appraise results management module through discussion.
Ethics Committee's appraisal meeting management information module notifies Ethics Committee, ethics expert and bidding for issuing conferencing information
Person or researcher carry out record and file generated to the content during appraisal meeting and save；Ballot management module is appraised through discussion to be used for
It collects and evaluates voting results on the line of ethics expert Signature Confirmation, summarize and formed and final appraise result through discussion；Appraise results management through discussion
Module receive appraise through discussion ballot management module send final result after, generate and send ethics official written reply, and notify sponsor or grind
The person of studying carefully signs for.
Further, in Ethic review management system in center provided in an embodiment of the present invention, other implementations are additionally provided
Mode, evaluating management subsystem includes that scheme modifying examines that unit, periodic review unit, serious adverse events examine unit, disobey
Carry on the back programme review unit, termination test examines unit and concluding a research item examines unit.
Scheme modifying examines that unit is used to carry out Ethic review to modified clinical test project.When clinical test project
Important attribute change after, need to re-start Ethic review to clinical test project, wherein important attribute includes: work
Skill, specification, auxiliary material, usage, dosage, indication, medication crowd and drug delivery regimen.Center Ethics Committee repairs mainly for scheme
Empirical risk after changing is assessed with benefited, makes examination reports.It is carried out in order to avoid causing promptly injury to subject
Scheme modifying, researcher can implement before submitting the examination and approval of center Ethics Committee, then again to center ethics committee member
It can turn in a report.
Periodic review unit is used to carry out tracking ethics to clinical test project according to time interval preset in unit to examine
It looks into.According to the degree of risk of test when center Ethics Committee initial review, the time interval that periodically tracking examines, default are determined
Value is 1 year.Center Ethics Committee submits the report of update to carry out tracking examination on schedule to researcher, again the wind of evaluation test
It is dangerous with it is benefited.Report information includes at least the progress of test, subject is included in number of cases, complete number of cases and exits number of cases, confirmation
And the serious adverse events reported and processing, risk are benefited event or new information.
Serious adverse events examine that unit is used to report according to the serious bad time for obtaining sponsor or researcher's offer
Tracking Ethic review is carried out to clinical test project.Degree and range including serious adverse events are benefited to empirical risk
Influence and the medical protection measure of subject.
Programme review unit is violated to be used for when there is non-compliance in the progress of clinical test project or violate scheme event, it is right
Clinical test project carries out Ethic review.Center Ethics Committee according to sponsor or researcher with regard to Non-Compliance the reason of, shadow
Loud and treatment measures explanations are examined, examine whether this influences the safety of subject and equity and whether influence to try
The risk tested is benefited.
Termination test examines that unit is used for when clinical test project terminates in advance, carries out ethics to clinical test project and examines
It looks into.The reason of termination test in advance that Ethics Committee reports according to sponsor or researcher, and to the subsequent place of subject
Reason, whether safety and equity to subject, which are guaranteed, examines.
Concluding a research item examine unit be used for applied concluding clinical test project carry out Ethic review, Ethics Committee according to
The performance report for the clinical test project that sponsor or researcher submit, whether the protection of examination subject's safety and equity
Close rule.
Ethic review management system in center provided by the embodiment of the present invention, comprising: centre management subsystem, ethics committee member
It can information bank subsystem, ethics experts database subsystem, project management subsystem, clinical test project examination applications management subsystem
With evaluate management subsystem.The clinical test project of typing is committed to clinical test project and examines application by project management subsystem
Management subsystem is confirmed that clinical test project examines that applications management subsystem generates the keyword of confirmation project, ethics committee
Member's meeting information bank subsystem establishes Ethics Committee's information bank, and matches selection in Ethics Committee's information bank according to keyword
Ethics committee member establishes Ethics Committee, and ethics expert recommendation list is submitted by Ethics Committee, and ethics experts database subsystem is according to human relations
Reason expert's recommendation list selects ethics expert, and centre management subsystem is used to carry out data friendship between subsystem connected to it
Mutually, and by ethics expert and ethics committee member it establishes as center Ethics Committee, center Ethics Committee is by evaluating management subsystem
System examine to clinical test project and be appraised through discussion, is ultimately generated examination and is appraised result through discussion.The technical solution is tried by using with clinic
It tests based on project data, the mode that Ethics Committee's information bank subsystem is combined with ethics experts database subsystem is selected
Center Ethics Committee committee member, center Ethics Committee have final decision-making power, avoid center Ethics Committee by fixing people
Member forms and influences the science and fairness of clinical test project appraisal, and, it avoids in the more families for participating in clinical test
The heart repeatedly examines unified clinical test project, further improves fairness, the science of clinical test Ethic review
And improve work efficiency, while realizing the information data tracking of the examination overall process of clinical test project, it alleviates existing
There is the technical problem that the fairness of Ethic review existing for technology is poor, checking process tracking is difficult.
Embodiment two:
Referring to Fig. 6, the flow chart of Ethic review management method in center provided in an embodiment of the present invention.It is provided in an embodiment of the present invention
Center Ethic review management method, comprising the following steps:
(1) ethics committee member's information that Ethics Committee's information bank subsystem typing this field worker submits, and by ethics committee member
Information is stored to Ethics Committee's information bank；
(2) project management subsystem receives the clinical test project that sponsor or researcher submit by centre management subsystem,
Typing item number is it is believed that breath；Primary investigators participate in the project information or school's project once participated in for sponsor simultaneously
The inquiry of project information；
(3) clinical test project examines the item number that the examination of applications management subsystem submits unit to obtain project management subsystem
It is believed that breath, examines that data confirmation unit carries out confirmation submission to the project of declaring according to project data information, and will confirm that submission
The project of declaring is sent to examination and results management unit is submitted to be recorded and issued, while will confirm that the project of declaring of submission is sent
To the formal examination unit for evaluating management subsystem；
(4) after confirmation is submitted, clinical test project examines that applications management subsystem also transfers project in project data information
Keyword, and project keyword is sent to Ethics Committee's information bank subsystem；
(5) Ethics Committee's information bank subsystem chooses symbol according to the project keyword of acquisition in Ethics Committee's information bank
Ethics committee member's information of project fields related request is closed, and notifies the corresponding composition of personnel Ethics Committee of ethics committee member's information,
The result of selection is fed back into clinical test project simultaneously and examines applications management subsystem；
(6) ethics experts database subsystem obtains the ethics expert that Ethics Committee submits by centre management subsystem and recommends to arrange
Table records the ethics expert info in ethics expert recommendation list, forms ethics experts database, carries out in ethics experts database random
It selects, generates ethics expert inventory；
(7) centre management subsystem obtains the project data information of project management subsystem, according to project data information and ethics
Committee member's information, and combine ethics expert inventory, establishes center Ethics Committee, and to center ethics committee member send evaluation permission and
Notice；
(8) it evaluates management subsystem and obtains the project of declaring that clinical test project examines the confirmation submission of applications management subsystem, and
Project examine and is appraised through discussion；It evaluates management subsystem and the notice of meeting of evaluation meeting is also sent to center Ethics Committee,
Finally sending project examines the examination result appraised through discussion and ethics official written reply to sponsor or researcher.
Further, in Ethic review management method in center provided in an embodiment of the present invention, step (8) specifically includes as follows
Step:
(8.1) formal examination unit receives clinical test project and examines that applications management subsystem confirms the project of declaring submitted, hair
It send formal examination to notify to center Ethics Committee secretary, and the formal examination content of recording secretary typing, while form being examined
It comes to an end fruit and formal examination opinion is sent to sponsor or researcher；
(8.2) after formal examination is qualified, first trial unit carries out preliminary inquiry, is read in ethics experts database by first trial unit at this time
Ethics expert info selects consultant expert automatically, and sends preliminary inquiry permission to consultant expert and center Ethics Committee,
Preliminary inquiry is carried out to project, preliminary inquiry result and preliminary inquiry opinion are sent to sponsor or researcher；First trial is qualified
First trial is sent afterwards passes through information to center Ethics Committee management of appraising unit；
(8.3) Ethics Committee's appraisal meeting management information module publication ethics evaluation of center Ethics Committee management of appraising unit
The conferencing information of meeting, and notice of meeting is sent to center Ethics Committee sponsor, researcher, to the meeting during appraisal meeting
View content is recorded, committee paper generates and committee paper saves；
(8.4) project of application is introduced by sponsor or researcher, ethics expert passes through page end or application program pair
It is voted, and submits after Signature Confirmation and appraises ballot management module through discussion, is summarized to ballot situation by the module and is formed most
Terminate fruit；After appraising results management module through discussion and receiving the final result for appraising ballot management module transmission through discussion, then ethics official written reply is generated,
And sponsor or researcher is notified to get.
Ethic review management method in center provided by the embodiment of the present invention, firstly, Ethics Committee's information bank subsystem
Ethics committee member's information that typing this field worker submits, establishes Ethics Committee's information bank；Secondly, project management subsystem is logical
It crosses centre management subsystem and receives the clinical test project that sponsor or researcher submit, typing item number is it is believed that breath；Clinic examination
It tests project and examines that applications management subsystem carries out submission confirmation to project, and transfer project keyword in project data information；
Again, Ethics Committee's information bank subsystem chooses ethics committee member information and forms ethics committee member according to the project keyword of acquisition
Meeting, while ethics expert's recommendation list of Ethics Committee's submission is obtained, and select ethics expert immediately；Then, centre management
Subsystem establishes center Ethics Committee according to project data information, ethics committee member information and ethics expert's inventory；Finally,
Center Ethics Committee examine to project by evaluating management subsystem and appraise through discussion, generates examination result and ethics official written reply.It should
Technical solution is by using based on clinical test project data information, Ethics Committee's information bank subsystem and ethics expert
The mode that library subsystem combines, selects center Ethics Committee committee member, and center Ethics Committee has final decision-making power, keeps away
Exempt from science and fairness that center Ethics Committee formed and influenced clinical test project appraisal by fixed personnel, and,
The center Duo Jia for avoiding participation clinical test repeatedly examines unified clinical test project, further improves clinical examination
Test the fairness, science and the full mistake of examination for improving work efficiency, while realizing clinical test project of Ethic review
The information data of journey tracks, and the fairness for alleviating Ethic review of the existing technology is poor, checking process tracking difficulty skill
Art 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. center Ethic review management system characterized by comprising centre management subsystem, Ethics Committee's information bank
System, ethics experts database subsystem, project management subsystem, clinical test project examine applications management subsystem and evaluate management
Subsystem；
Ethics Committee's information bank subsystem, ethics experts database subsystem, project management subsystem, clinical test project are examined
It looks into applications management subsystem and evaluates management subsystem and connect respectively with centre management subsystem；The ethics experts database subsystem
Examine that applications management subsystem is connect with the management subsystem of evaluating respectively with clinical test project, Ethics Committee's letter
Breath library subsystem and the project management subsystem examine that applications management subsystem is connect with the clinical test project respectively；
Ethics committee member's information that Ethics Committee's information bank subsystem typing this field worker submits, and by ethics committee member
Information is stored to Ethics Committee's information bank；
The project management subsystem receives the clinical test that sponsor or researcher submit by the centre management subsystem
Project, typing item number is it is believed that breath；The project management subsystem is also used to the project information or school that sponsor once participated in
The inquiry for the project information that primary investigators participate in project；
The clinical test project examines that applications management subsystem obtains the project data information of project management subsystem, according to item
Mesh data information carries out submission confirmation to the project of declaring, and for confirming the record for declaring project submitted and inquiry, will also examine
It submits result to record and issue, while will confirm that the project of declaring of submission is sent to the formal examination list for evaluating management subsystem
Member；After confirmation is submitted, clinical test project examines that applications management subsystem also transfers project key in project data information
Word, and the project keyword is sent to Ethics Committee's information bank subsystem；
Ethics Committee's information bank subsystem chooses symbol according to the project keyword of acquisition in Ethics Committee's information bank
Ethics committee member's information of project fields related request is closed, and notifies the corresponding composition of personnel Ethics Committee of ethics committee member's information,
The result of selection is fed back into clinical test project simultaneously and examines applications management subsystem；
The ethics experts database subsystem obtains the ethics expert that Ethics Committee submits by centre management subsystem and recommends column
Table records the ethics expert info in the ethics expert recommendation list, forms ethics experts database, carries out in ethics experts database
It selects at random, generates ethics expert inventory；
The centre management subsystem obtains the project data information of project management subsystem, according to project data information and ethics
Committee member's information, and in conjunction with the ethics expert inventory, center Ethics Committee is established, and send evaluation power to center ethics committee member
Limit and notice；
It is described evaluate management subsystem and obtain the clinical test project examine that the confirmation of applications management subsystem submitted declares item
Mesh, and project examine and is appraised through discussion；The notice of meeting of evaluation meeting is also sent to center human relations by the management subsystem of evaluating
The reason committee finally sends project and examines the examination result appraised through discussion and ethics official written reply to sponsor or researcher.
2. center Ethic review management system according to claim 1, which is characterized in that the management subsystem of evaluating includes
Formal examination unit, first trial unit and center Ethics Committee management of appraising unit；
The input terminal of the formal examination unit receives the clinical test project and examines what the confirmation of applications management subsystem was submitted
Declare project, send formal examination and notify to center Ethics Committee secretary, and the formal examination opinion of recording secretary typing and
As a result, formal examination result and formal examination opinion are sent to sponsor or researcher simultaneously；
After the input terminal of the first trial unit receives the information of formal examination qualification, typing consultant expert and Ethics Committee
The preliminary inquiry result and opinion of committee member, while preliminary inquiry result and opinion are sent to sponsor or researcher, after qualified
Pass signal is sent to center Ethics Committee management of appraising unit；
Center Ethics Committee management of appraising unit evaluates clinical test project, and result and ethics official written reply are appraised in generation through discussion,
And notice is sent to sponsor or researcher.
3. center Ethic review management system according to claim 2, which is characterized in that the center Ethics Committee evaluation
Administrative unit includes Ethics Committee's appraisal meeting management information module, appraises ballot management module through discussion and appraise results management module through discussion；
Ethics Committee's appraisal meeting management information module notifies Ethics Committee, ethics special for issuing conferencing information
Family and sponsor or researcher carry out record and file generated to the content during appraisal meeting and save；It is described to appraise ballot through discussion
Management module, which is used to collect, to be evaluated voting results, summarizes and formed and final appraise result through discussion on the line of ethics expert's Signature Confirmation；
It is described appraise through discussion results management module receive appraise through discussion ballot management module send final result after, generate and send ethics official written reply,
And sponsor or researcher is notified to sign for.
4. center Ethic review management system according to claim 1, which is characterized in that the management subsystem of evaluating includes
Scheme modifying examines that unit, periodic review unit, serious adverse events examine unit, violate programme review unit, termination test
Examine that unit and concluding a research item examine unit；
The scheme modifying examines that unit is used to carry out Ethic review to modified clinical test project；
The periodic review unit is used to carry out tracking ethics to clinical test project according to time interval preset in unit to examine
It looks into；
The serious adverse events examine the serious bad time report that unit is used to provide according to sponsor or researcher is obtained
Tracking Ethic review is carried out to clinical test project；
The programme review unit of violating is used for when there is non-compliance in the progress of clinical test project or violate scheme event, right
Clinical test project carries out Ethic review；
The termination test examines that unit is used for when clinical test project terminates in advance, carries out ethics to clinical test project and examines
It looks into；
The concluding a research item examines that unit is used for the clinical test project progress Ethic review for having applied for concluding.
5. center Ethic review management system according to claim 1, which is characterized in that Ethics Committee's information bank packet
Include basic information unit (BIU), ethics committee member information unit, committee member's change record unit, Ethics Committee's training record unit and ethics
Organize document element；Wherein, the basic information unit (BIU) for store Ethics Committee's title, ethics responsible person, ethics secretary,
Address and telephone number；The ethics committee member information unit is for recording ethics committee member name, gender, date of birth, educational background, institute
It learns profession, Major research field, history and participates in project and training historical information；Committee member's changing unit is for recording change committee
The name of member and committee member change the time；Ethics Committee's training record unit is used for name, training to training committee member is participated in
Instruction date, training contents and training duration are managed；The ethics tissue document element is for establishing Ethics Committee's management
System, Ethics Committee's Standard Operating Procedure, emergency event prediction scheme and foregoing units data file generated.
6. center Ethic review management system according to claim 1, which is characterized in that the project management subsystem includes
Clinical drug trial project management unit, Medical Deuice Clinical Trial project management unit, kit clinical test project management
Unit and scientific research task project management unit, are respectively used to the pilot project management of different development test objects.
7. center Ethic review management system according to claim 6, which is characterized in that the clinical drug experimental project pipe
Manage unit, Medical Deuice Clinical Trial project management unit, kit clinical test project management unit and scientific research task project
It include establishment of item module and history item information management module in administrative unit；
Essential information, drug information and the inclusion criteria of subject, exclusion in the establishment of item module including pilot project
Standard and exit standard, wherein the drug information includes trial drug information and comparison medicine information；The history item information
The project information that Principal Investigator participates in the project information or school's project once participated in management module including sponsor；
Data attribute in the history item information management module is read-only.
8. center Ethic review management system according to claim 1, which is characterized in that the clinical test project examines Shen
Please management subsystem include examine submit unit, examine data confirmation unit and examine submit results management unit；
Described examine in the input terminal and project management subsystem of submitting unit connects between each establishment of item module, described to examine
Look into the project data information for submitting unit to obtain project management subsystem；
The examination data confirmation unit is for sponsor or supervisor according to sponsor and researcher in project management subsystem
The project data information of submission carries out confirmation submission to the project of declaring, and will confirm that the project of declaring of submission is sent to examination and submits knot
Fruit administrative unit is recorded and is inquired, at the same will confirm that the project of declaring of submission be sent to evaluate management subsystem form examine
Unit starting examination is looked into appraise through discussion；
The examination submits results management unit to send the successful short message of submission or mail to sponsor, researcher and supervisor；
It examines that submitting results management unit that will also examine submits result to issue, and carries out result queries for supervisor；
The examination submits results management unit also after pilot project confirmation is submitted, to transfer project in project data information
Keyword, and the project keyword is sent to Ethics Committee's information bank subsystem.
9. center Ethic review management method, which comprises the following steps:
(1) ethics committee member's information that Ethics Committee's information bank subsystem typing this field worker submits, and by ethics committee member
Information is stored to Ethics Committee's information bank；
(2) project management subsystem receives the clinical test project that sponsor or researcher submit by centre management subsystem,
Typing item number is it is believed that breath；Primary investigators participate in the project information or school's project once participated in for sponsor simultaneously
The inquiry of project information；
(3) clinical test project examines the item number that the examination of applications management subsystem submits unit to obtain project management subsystem
It is believed that breath, examines that data confirmation unit carries out confirmation submission to the project of declaring according to project data information, and will confirm that submission
The project of declaring is sent to examination and results management unit is submitted to be recorded and issued, while will confirm that the project of declaring of submission is sent
To the formal examination unit for evaluating management subsystem；
(4) after confirmation is submitted, clinical test project examines that applications management subsystem also transfers project in project data information
Keyword, and the project keyword is sent to Ethics Committee's information bank subsystem；
(5) Ethics Committee's information bank subsystem chooses symbol according to the project keyword of acquisition in Ethics Committee's information bank
Ethics committee member's information of project fields related request is closed, and notifies the corresponding composition of personnel Ethics Committee of ethics committee member's information,
The result of selection is fed back into clinical test project simultaneously and examines applications management subsystem；
(6) ethics experts database subsystem obtains the ethics expert that Ethics Committee submits by centre management subsystem and recommends to arrange
Table records the ethics expert info in the ethics expert recommendation list, forms ethics experts database, carries out in ethics experts database
It selects at random, generates ethics expert inventory；
(7) centre management subsystem obtains the project data information of project management subsystem, according to project data information and ethics
Committee member's information, and combine ethics expert inventory, establishes center Ethics Committee, and to center ethics committee member send evaluation permission and
Notice；
(8) it evaluates management subsystem and obtains the project of declaring that clinical test project examines the confirmation submission of applications management subsystem, and
Project examine and is appraised through discussion；It evaluates management subsystem and the notice of meeting of evaluation meeting is also sent to center Ethics Committee,
Finally sending project examines the examination result appraised through discussion and ethics official written reply to sponsor or researcher.
10. Ethic review management method in center according to claim 8, which is characterized in that step (8) specifically includes as follows
Step:
(8.1) formal examination unit receives clinical test project and examines that applications management subsystem confirms the project of declaring submitted, hair
It send formal examination to notify to center Ethics Committee secretary, and the formal examination content of recording secretary typing, while form being examined
It comes to an end fruit and formal examination opinion is sent to sponsor or researcher；
(8.2) after formal examination is qualified, first trial unit carries out preliminary inquiry, is read in ethics experts database by first trial unit at this time
Ethics expert info selects consultant expert automatically, and sends preliminary inquiry permission to consultant expert and center Ethics Committee,
Preliminary inquiry is carried out to project, preliminary inquiry result and preliminary inquiry opinion are sent to sponsor or researcher；First trial is qualified
First trial is sent afterwards passes through information to center Ethics Committee management of appraising unit；
(8.3) Ethics Committee's appraisal meeting management information module publication ethics evaluation of center Ethics Committee management of appraising unit
The conferencing information of meeting, and notice of meeting is sent to center Ethics Committee sponsor, researcher, to the meeting during appraisal meeting
View content is recorded, committee paper generates and committee paper saves；
(8.4) project of application is introduced by sponsor or researcher, ethics expert passes through page end or application program pair
It is voted, and submits after Signature Confirmation and appraises ballot management module through discussion, is summarized to ballot situation by the module and is formed most
Terminate fruit；After appraising results management module through discussion and receiving the final result for appraising ballot management module transmission through discussion, then ethics official written reply is generated,
And sponsor or researcher is notified to get.
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| 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 |
| CN112650783A (en) * | 2021-01-07 | 2021-04-13 | 甘肃省科学技术情报研究所（甘肃省科学技术发展战略研究院） | Scientific and technological information retrieval method and system |
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| CN107480456A (en) * | 2017-08-22 | 2017-12-15 | 浙江大学医学院附属第医院 | clinical trial management method and system |
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Application publication date: 20190412 |