CN107480456A - clinical trial management method and system - Google Patents
clinical trial management method and system Download PDFInfo
- Publication number
- CN107480456A CN107480456A CN201710724386.4A CN201710724386A CN107480456A CN 107480456 A CN107480456 A CN 107480456A CN 201710724386 A CN201710724386 A CN 201710724386A CN 107480456 A CN107480456 A CN 107480456A
- Authority
- CN
- China
- Prior art keywords
- information
- testing program
- clinical
- subject
- testing
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medical Treatment And Welfare Office Work (AREA)
Abstract
The invention discloses a kind of clinical trial management method and system, wherein, method includes：Trial drug information is obtained, trial drug information is audited according to default drug information, pilot project is established according to auditing result；Testing program is built according to pilot project；Testing program includes research contents information and conceptual phase information；Subject information is gathered according to testing program, by subject information's typing testing program；The relevant clinical that research contents information is carried out according to conceptual phase information according to subject information is tested, and obtains corresponding clinical testing data, and is recorded into testing program, completes clinical trial management.The present invention is managed concentratedly by testing program to subject, and record related data, so that verified conveniently with prescription and supervision department, researcher's synchronous real time data at any time, realize variation, the integrated management to clinical test, reduce the chaotic phenomenon of clinical testing data, strengthen the reliability of clinical pharmacology result of the test.
Description
Technical field
The present invention relates to technical field of information management, more particularly to a kind of clinical trial management method and system.
Background technology
Clinical test is a complicated test system, and it is multi-party to be related to pathology, pharmacology, ethics, statistics etc.
The content in face.Promulgated according to State Food and Drug Administration《GCP》Middle clinical test
Definition, clinical test refer to it is any human body (patient or healthy volunteer) carry out medicine systematic Study, with confirm or
Disclose effect, adverse reaction and/or the absorption of trial drug, distribution, metabolism and the excretion of trial drug, it is therefore an objective to it is determined that experiment
The effect of medicine and security.Abroad, the personnel of participation clinical test are referred to as volunteer, the country is commonly referred to as " tested
Person ", the people of volunteer the inside unsoundness, also there is patient, and it is which type of experiment participated in that this, which mainly sees,.We are usually in the most contact
Experiment, or by patient participate in, it is therefore intended that investigate new drug either with or without curative effect, either with or without the experiment of side effect.It is large-scale by three
First hospital is borne by the pilot project of hundreds of every year, is entrusted by drugmaker and makees asynchronous clinic for the listing of medicine
Experimental study, large quantities of subjects need to be recruited to carry out subject and observe the reaction of medicine.
Management of the current nearly all hospital for subject all also relies on Hospitals at Present clinically in one used
A system, doctor's advice system of being in hospital etc. are examined in a little existed systems, such as outpatient service so that the management of subject is complete as common patient
Into basic demand；Because data are relatively isolated between different system, it is easy to cause that data record is imperfect, data transfer is stagnant
The problems such as afterwards, design data is random big, data statistic analysis is not professional, subject's management is lack of standardization, cause pharmacy side,
Verified with prescription and supervision department it is difficult, researcher can not synchronous real time data, phenomena such as data corruption, have impact on clinical pharmacology
The reliability of result of the test.
The content of the invention
It is an object of the invention to provide a kind of clinical trial management method and system, and the present invention is by testing program to tested
Person is managed concentratedly, and records related data so that it is convenient to be verified with prescription and supervision department, and researcher is synchronous at any time in real time
Data, variation, integrated management to clinical test are realized, reduce the chaotic phenomenon of clinical testing data, enhancing is faced
The reliability of bed pharmacological tests.
The invention provides a kind of clinical trial management method, comprise the following steps：
Trial drug information is obtained, the trial drug information is audited according to default drug information, according to examination ＆ verification
As a result pilot project is established；
Testing program is built according to the pilot project；The testing program includes research contents information and conceptual phase is believed
Breath；
Subject information is gathered according to the testing program, by testing program described in subject information's typing；
The relevant clinical of the research contents information is carried out according to the conceptual phase information according to the subject information
Experiment, obtains corresponding clinical testing data, and records into the testing program, completes clinical trial management.
It is described that testing program is built according to the pilot project as a kind of embodiment, comprise the following steps：
The pilot project is divided, obtains conceptual phase information；
The pilot project is handled according to conceptual phase information, obtains research contents information；
Two-dimentional relation combination is carried out according to the conceptual phase information and the research contents information, and passes through communications protocol
Docked with medical matters built-in system, generate testing program.
It is described that testing program is built according to the pilot project as a kind of embodiment, it is further comprising the steps of：
Before the pilot project is divided, according to default researcher's information and corresponding authority pair
The Testing items setting test type, obtains test type information.
It is described that testing program is built according to the pilot project as a kind of embodiment, it is further comprising the steps of：
After research contents information is obtained, the research contents information is classified, obtains classifies content information.
As a kind of embodiment, clinical trial management method provided by the invention is further comprising the steps of：
Face in the correlation for carrying out the research contents information according to the conceptual phase information according to the subject information
After bed experiment, cost data is obtained, book keeping operation processing is carried out according to the cost data, and generate multidimensional financial statement.
Accordingly, the present invention also provides a kind of clinical trial management system, including trial drug acquisition module, testing program
Build module, subject's recording module and clinical trial management module；
The trial drug acquisition module, for obtaining trial drug information, according to default drug information to the experiment
Drug information is audited, and pilot project is established according to auditing result；
The testing program builds module, for building testing program according to the pilot project；The testing program bag
Include research contents information and conceptual phase information；
Subject's recording module, for gathering subject information according to the testing program, the subject is believed
Cease in testing program described in typing；
The clinical trial management module, for carrying out institute according to the conceptual phase information according to the subject information
The relevant clinical experiment of research contents information is stated, obtains corresponding clinical testing data, and is recorded into the testing program, is completed
Clinical trial management.
As a kind of embodiment, the testing program structure module includes division unit, processing unit and combination
Unit；
The division unit, for the pilot project to be divided, obtain conceptual phase information；
The processing unit, for the pilot project to be handled according to conceptual phase information, obtain research contents
Information；
The assembled unit, for carrying out two-dimentional relation group according to the conceptual phase information and the research contents information
Close, and docked by communications protocol with medical matters built-in system, generate testing program.
As a kind of embodiment, the testing program builds module, in addition to setting unit；
The setting unit, for before the pilot project is divided, according to default researcher's information
With corresponding authority to the Testing items setting test type, test type information is obtained.
As a kind of embodiment, the testing program builds module, in addition to taxon；
The taxon, for after research contents information is obtained, classifying to the research contents information, obtaining
To classifies content information.
As a kind of embodiment, the clinical trial management module also includes financial statement unit；
The financial statement unit, described in being carried out according to the subject information according to the conceptual phase information
After the relevant clinical experiment of research contents information, cost data is obtained, book keeping operation processing is carried out according to the cost data, and it is raw
Into multidimensional financial statement.
Compared with prior art, this technology testing program has advantages below：
Clinical trial management method and system provided by the invention, first according to default drug information to trial drug information
Audited, pilot project is established according to auditing result, testing program is built further according to pilot project；Pass through the experiment side of structure
Case completes subjects recruitment, and has been tested according to the relevant clinical of the conceptual phase information of testing program progress research contents information
The clinical trial management of paired subject.Subject is managed concentratedly by testing program, and records related data so that
It is convenient to be verified with prescription and supervision department, researcher's synchronous real time data at any time, realizes variation to clinical test, one
Change management, reduce the chaotic phenomenon of clinical testing data, strengthen the reliability of clinical pharmacology result of the test.
Brief description of the drawings
Fig. 1 is the schematic flow sheet for the clinical trial management method that the embodiment of the present invention one provides；
Fig. 2 is the schematic flow sheet that pilot project is established in Fig. 1；
Fig. 3 is the structural representation for the clinical trial management system that the embodiment of the present invention two provides.
In figure：100th, trial drug acquisition module；200th, testing program structure module；210th, setting unit；220th, divide
Unit；230th, processing unit；240th, taxon；250th, assembled unit；300th, subject's recording module；400th, clinical test pipe
Manage module；410th, financial statement unit.
Embodiment
Below in conjunction with accompanying drawing, the technical characteristic above-mentioned and other to the present invention and advantage are clearly and completely described,
Obviously, described embodiment is only the section Example of the present invention, rather than whole embodiments.
Referring to Fig. 1, the clinical trial management method that the embodiment of the present invention one provides, comprises the following steps：
S100, trial drug information is obtained, trial drug information is audited according to default drug information, according to examination ＆ verification
As a result pilot project is established；
S200, according to pilot project build testing program；Testing program includes research contents information and conceptual phase information；
S300, according to testing program gather subject information, by subject information's typing testing program；
S400, the relevant clinical experiment according to subject information according to conceptual phase information progress research contents information, are obtained
To corresponding clinical testing data, and record into testing program, complete clinical trial management.
It should be noted that after relevant item contract is signed, trial drug storage trial drug central pharmacy completes examination
The acquisition of drug information is tested, can be by way of manually directly inputting and/or scanning input.Trial drug information is recorded again
Enter pharmacy databases, obtain trial drug database；So as to which trial drug and normal drug be separated, trial drug information is avoided
Data corruption.Default drug information is exactly the standard information of each trial drug, by by default drug information and investigational agent
Thing information the mode such as is contrasted, judged, being screened and being audited, and pilot project is established after in examination ＆ verification.And need
The trial drug information of examination ＆ verification not only includes essential information, batch information, term of validity information and the number information of trial drug.
Also include caused data after being operated every time to trial drug, for example inventory information, go out to be put in storage information, drug putting operation, medicine
The careful side of thing prescription, the examination ＆ verification of section office's recovery medicine, medicine recovery of manufacturer etc..
As shown in Fig. 2 the detailed process for establishing pilot project includes project application, Ethic review, contract are signed, drug reservoir
Foundation and startup can be held.
S110, project application are made a report on and audited including project, and project is made a report on, in institute personnel's account be by pilot project with
Personnel information is imported what is directly generated by hospital's OA system dockings, and personnel are then needed by registering account in pilot project outside institute
Number, generated after then being audited；And need to distribute corresponding authority for no user account, can be different by distributing
To define the authority of relative users, (role can be divided into sponsor, researcher, project leader, the head of the department, office to role
Secretary, office director etc.)；Sponsor carries out making a report on online for project after logging in pilot project, and uploads project data,
Confirm that the examination ＆ verification stage will be entered after submitting, the examination ＆ verification stage can be divided into director's examination ＆ verification, the head of the department is audited, office is examined
Core, the user of different role enter after system in ' mine is pending ' it can be seen that current Pending tasks (task based access control driving
Orderly management), can carry out in review process project data it is online read and make comments and extract read and make comments the reason that information is rejected as project
By mechanism examination ＆ verification will generate unique number of accepting by rear project, greatly reduce the workload of project examination ＆ verification；Existed by project
Line, which is made a report on, will successfully create the pilot project storehouse of full institute, and the related information of project and project data data can be carried out association and search
Rope and check, and different role user possesses the different operation authority of project and the project of different range checks authority (I fills out
Report project, I be responsible for project, certain special interest group project, full institute's project etc.).
S120, Ethic review are the stage just entered after the examination ＆ verification of project application mechanism passes through, and Ethic review includes initial examine
Look into, amendment examines, persistently the type such as examination, the detection of adverse events and assessment, different examination types need to fill in differ
The application content of sample but possess identical workflow management；Project leader carries out Ethic review application online, fills in application content
With upload ethics data, after confirming and submitting, ethics secretary carry out project formal examination, formal examination by it is rear be each item
Mesh distributes two and examined, trials and the contents of a project and project data are examined in checking process, and submit examination
As a result, ethically after the meeting, can carry out ethics meeting committee member of attending the meeting in system it is online register, the human relations that the project of checking is submitted online
Reason data, ethics secretary fill in meeting summary, the ballot etc. online of Ethic review result, system can be tied automatically according to ballot online
Project is rejected or by the way that project of the Ethic review after can generate ethics official written reply online by fruit.
S130, contract management are to pass through and successfully obtain stage for just entering after ethics official written reply, project in ethics examination ＆ verification
After contract is signed successfully, need immediately by important information (defined cost information such as in contract) input system of contract, and will
Contract scanned copy is passed to system and referred to for the later stage, will be the unique contract number of each project construction after the completion of contract inputting, subsequently
Contract number is using as the unique mark of the project in the progress of flow.
S140, drug reservoir establish be contract management by and success after stage for just entering, believed according to default medicine
Breath is audited and is put in storage to trial drug information, and drug reservoir is established further according to trial drug information.
Start can hold be contract management by and success after stage for just entering, the stage can be carried out can also
Directly skip.
Testing program is the strict pilot project structure with reference to corresponding to, and testing program is to define each subject in phase
The conceptual phase information conceptual phase cycle of certain time scope (have) answered need to carry out corresponding research contents information and
Assess the tables of data of information.Information is assessed to be included in clinical testing data.Clinical test was entered according to the periodic stage
OK, the test period of different trial drugs is usually different；So pilot project is divided, conceptual phase letter is obtained
Breath.Here conceptual phase information can be screening, test period, treatment termination, follow-up etc.；And the stage is provided on request
Time started and end time., can be with and research contents information is exactly to need the research contents that carries out in corresponding conceptual phase
It is informed consent, selected, physical examination, drug combination, tumor evaluation, administration, vital sign, adverse events etc..In other realities
Apply in example, the information such as testing program content, eCRF (report of subject's electronic medical recordses) can also be added in testing program.
Collection for subject information is it should be noted that be the subject information according to testing program to recruitment first
Screened, filter out the subject information of Pass Test scheme, and according to recruitment time sequencing by subject information's typing,
Also can directly by subject the court medical card number/medical record number by communications protocol from existing hospital internal system it is complete
Typing is screened into subject information；For example subject is selected according to rule generation in the subject recruitment page, screening number
Type (outpatient service/be in hospital), input card number/medical record number search by by way of WebService or HttpClient directly from
Data are obtained in HIS, greatly reduce the time of information input；" preservation " button is clicked on after confirmation is errorless, will be according to rule
Work judges, for example, other experiments whether were participated in three months, whether outpatient pretends to be inpatient, is being in hospital
Patient participates in experiment of other outpatient services etc.；After increasing newly successfully subject will appear in left side menu, different colors represent by
Examination person's state (normal assays, screening not by, reject etc.).
Clinical trial management method provided by the invention, trial drug information is examined according to default drug information first
Core, pilot project is established according to auditing result, testing program is built further according to pilot project；Completed by the testing program of structure
Subjects recruitment, and according to the conceptual phase information of testing program carry out research contents information relevant clinical experiment complete to by
The clinical trial management of examination person.Subject is managed concentratedly by testing program, and records related data so that uses prescription
It is convenient to be verified with supervision department, researcher's synchronous real time data at any time, realizes variation to clinical test, integration pipe
Reason, reduce the chaotic phenomenon of clinical testing data, strengthen the reliability of clinical pharmacology result of the test.
Further, step S200 comprises the following steps：
S210, pilot project divided, obtain conceptual phase information；
S220, pilot project handled according to conceptual phase information, obtain research contents information；
S230, carry out two-dimentional relation combination according to conceptual phase information and research contents information, and by communications protocol with
Medical matters built-in system is docked, and generates testing program.
The design of testing program：Based on modularization, configurable mentality of designing, the behavior of subject below is built upon
In testing program, testing program can be decomposed into a two-dimentional relation to treat, and y is research contents, and x is conceptual phase, both
Between form two-dimentional relation.Clinical test was carried out according to the periodic stage, the test period one of different trial drugs
As be different；So pilot project is divided, conceptual phase information is obtained.Conceptual phase information setting each stage when
Between scope, and whole experiment of the time range to subject according to corresponding to the stage make in advance the time be expected prompting (administration
Time etc.), early warning etc.；Research contents information is exactly to correspond to specific clinical behavior in each conceptual phase to have chemical examination, medical technologies inspection
Look into, write a prescription, informed consent, entering a group examination, eCRF etc..It will greatly reduce the later stage according to testing program to carry out clinical trial management
(testing program and subject are 1 to running cost after this subject recruitment：N relation), and also by the clinical row of subject
Strictly to confine on the design of testing program, the Quality Control to clinical test provides foundation；Provided according to each testing program
Case report no pattern carry out eCRF (report of subject's electronic health record), for later stage subject correlation case history insert.Trying
Some rules can also be set according to research contents information in proved recipe case；Such as screening rule (definition screening number digit and
Combined arrangement, corresponding screening number is automatically generated when being screened for subject), to enter row's standard (defined selected in testing program
, should be by and exclusion standard, main subject do not meet the selected rule of any of which one or meet any one exclusion standard
Examination person is by screening failure), pk take a blood sample/adopt urine time point rule (design continuous sampling time point, such as+0h ,+0.5h,
+ 1h ,+1.25h ,+1.5h ,+2.0h etc., the time point is represented using administration time as reference, more before and after administration time
Sampled in few time, then blood sampling time of the system according to time point rule referring again to the automatic computational theory of administration time) etc. rule
Then.Testing program realizes the centralized management of all behaviors of subject (by all subjects' of single project from vertical dimensions
Clinical behavior is managed concentratedly, intuitively reacts very much all subject's situations of the project), realize clinical test from horizontal dimensions
Integrated management (enter group after the informed consent of single subject and successfully complete the whole process pipe of the experiment up to subject
Reason).
Two-dimentional relation combination is carried out according to conceptual phase information and research contents information, and by communications protocol and medical matters
Portion's system is docked；Such as directly obtained by way of WebService or HttpClient from HIS it is existing by
Examination person's information data；Or data to be used are obtained from LIS, PACS；It is seamless right with hospital system HIS, LIS, PACS etc.
Connect so that it is relatively independent but not isolated (data having are still suffered from hospital system), varigrained data are all associated
Together, the data of research are difficult to comprehensively show.
Further, step S200 is further comprising the steps of：
Before pilot project is divided, according to default researcher's information and corresponding authority to experiment
Item setup test type, obtain test type information.
It should be noted that according to corresponding to Testing items setting testing program test type information, according to default
Researcher's information and corresponding authority carry out the setting of test type to pilot project；Test type information includes opening
Put, single blind and three kinds of double blinding；What the type for distinguishing experiment directly affected later stage test recipe opens mode；It is default to grind
Studying carefully personnel includes researcher, research nurse, medication management, CRC etc., and different researchers corresponds to different authorities.If
It is open, then when doctor prescribes direct validation test medicine numbering (characteristic information), realize the collection of prescription information；
If single blind/double blinding, the numbering of trial drug is not selected when doctor opens prescription, in research nurse to experiment
During pharmaceutical drug taking, then the input of the numbering of trial drug is carried out, realize the collection of prescription information.It is follow-up to carry out outbound processing.
Further, step S200 is further comprising the steps of：
After research contents information is obtained, research contents information is classified, obtains classifies content information.
Research contents information is classified, CRF, inspection, inspection, administration etc., the purpose of classifies content information can be divided into
It is to realize that subject can design the platform of different research contents the executive mode of differentiation, finally by independent conceptual phase
Information and research contents information are combined by two-dimentional relation, realize that different conceptual phases corresponds to corresponding research contents,
Realize variation, the integration of clinical test.
Further, clinical trial management method is further comprising the steps of：
After the relevant clinical experiment of research contents information is carried out according to conceptual phase information according to subject information, obtain
To cost data, book keeping operation processing is carried out according to cost data, and generate multidimensional financial statement.
Relevant clinical experiment generation multidimensional financial statement is carried out to subject according to testing program to illustrate：
In subject's management region, the stage residing for new subject, acquiescence was first stage, and can show this stage
All Pending tasks, task-driven, next stage, the more tab page face Dynamic Announces in bottom could be entered by completing all tasks
Research contents (according to stage dynamic change) corresponding to the stage, due to the difference of Outpatient Service Flow and Hospitalization Process, each point
Hit the Information Proofreading subject that subject can be by way of WebService or HttpClient and in hospital HIS system
Type (being outpatient or inpatient), the change of subject's type, the type (outpatient service/be in hospital) of subject are carried out in time
The actual execution route of research contents will be influenceed；What inspection/inspection obtained in the definition by the cycle in testing program, batch
Execution, system automatic charging (are not required to pay for first), and outpatient directly arrives window blood drawing/registration, and inpatient flows by being in hospital
Cheng Jinhang, additionally opening not defined in testing program singly can arrive " additionally opening list " place and open, it is necessary to write out single reason exactly；
All inspection/inspection results of the subject can be checked in history inspection/checklist, divide disparity items cycle, different patients
Type (outpatient service/be in hospital), automatically extracts abnormal index, and remind researcher to report AE (anomalous event)；Single medicine is opened in selection (should
The medicine of project storage), selection numbering (open trial selects reference numeral, and single blind/double blinding does not select then), it is unified to open Dan doctor
Verification is fallen, and can enter pharmacy drug putting (period can cancel, cancel) after verification, corresponding people to test center pharmaceutical drug taking,
All new effective prescriptions of the subject can be checked in history prescription list, move back medicine operation to dispensing, writes reason exactly
(need sponsor's documentary evidence can), pharmacy have confirmation to operate, and medicine is recycled to test center pharmacy, pharmacy management by each section office
Member is checked；
When above-mentioned subject carries out relevant clinical experiment according to testing program, the research contents of each conceptual phase is complete
Data statistics and the input of form can be all carried out after, institution of clinical trial administrative department can will in real time monitor each of each special interest group
The progress situation of individual project, and financial data is shown with various dimensions, carry out disbursement and sattlement for hospital financial department and manufacturer.It is all
Clinical test subjects recruitment after, subject is free by drug research needs carried out chemical examination, medical technologies inspection etc.
Carry out, the unified cost issues settled accounts, successfully solve subject of multidimensional financial statement that pharmaceutical factory can be with hospital according to generation, no
Numerous and diverse operation that subject's disbursement is submitted an expense account again is needed, by the quality of guarantee test while clinical test is facilitated.
Based on same inventive concept, the embodiment of the present invention also provides a kind of clinical trial management system, the implementation of the system
The process that can refer to the above method is realized, it is no longer redundant later to repeat part.
As shown in figure 3, being the structural representation for the clinical trial management system that the embodiment of the present invention two provides, including test
Medicine acquisition module 100, testing program structure module 200, subject's recording module 300 and clinical trial management module 400；
Trial drug acquisition module 100 is used to obtain trial drug information, and trial drug is believed according to default drug information
Breath is audited, and pilot project is established according to auditing result；
Testing program structure module 200 is used to build testing program according to pilot project；Testing program includes research contents
Information and conceptual phase information；
Subject's recording module 300 is used to gather subject information according to testing program, and subject information's typing is tested
In scheme；
Clinical trial management module 400 is used to carry out research contents information according to conceptual phase information according to subject information
Relevant clinical experiment, obtain corresponding clinical testing data, and record into testing program, complete clinical trial management.
Further, testing program structure module 200 includes division unit 220, processing unit 230 and assembled unit
250；
Division unit 220 is used to be divided pilot project, obtains conceptual phase information；
Processing unit 230 is used to be handled pilot project according to conceptual phase information, obtains research contents information；
Assembled unit 250 is used to carry out two-dimentional relation combination according to conceptual phase information and research contents information, and passes through
Communications protocol is docked with medical matters built-in system, generates testing program.
Further, testing program structure module 200, in addition to setting unit 210；
Setting unit 210 be used for before pilot project is divided, according to default researcher's information and and its
Corresponding authority obtains test type information to Testing items setting test type；
The authority according to corresponding to test type information distributes researcher and setting.
Further, testing program structure module 200 also includes taxon 240；
Taxon 240 is used for after research contents information is obtained, and research contents information is classified, classified
Content information.
Further, clinical trial management module 400 also includes financial statement unit 410；
Financial statement unit 410, for carrying out research contents information according to conceptual phase information according to subject information
Relevant clinical experiment after, obtain cost data, book keeping operation processing carried out according to cost data, and generate multidimensional financial statement.
Clinical trial management system provided by the invention, trial drug information is examined according to default drug information first
Core, pilot project is established according to auditing result, testing program is built further according to pilot project；Completed by the testing program of structure
Subjects recruitment, and according to the conceptual phase information of testing program carry out research contents information relevant clinical experiment complete to by
The clinical trial management of examination person.Subject is managed concentratedly by testing program, and records related data so that uses prescription
It is convenient to be verified with supervision department, researcher's synchronous real time data at any time, realizes variation to clinical test, integration pipe
Reason, reduce the chaotic phenomenon of clinical testing data, strengthen the reliability of clinical pharmacology result of the test.
Although the present invention is disclosed as above with preferred embodiment, it is not for limiting the present invention, any this area
Technical staff without departing from the spirit and scope of the present invention, may be by the methods and technical content of the disclosure above to this hair
Bright engineering test scheme makes possible variation and modification, therefore, every content without departing from the technology of the present invention testing program, according to
Any simple modifications, equivalents, and modifications made according to the technical spirit of the present invention to above example, belong to the present invention
The protection domain of engineering test scheme.
Claims (10)
- A kind of 1. clinical trial management method, it is characterised in that comprise the following steps：Trial drug information is obtained, the trial drug information is audited according to default drug information, according to auditing result Establish pilot project；Testing program is built according to the pilot project；The testing program includes research contents information and conceptual phase information；Subject information is gathered according to the testing program, by testing program described in subject information's typing；The relevant clinical that the research contents information is carried out according to the conceptual phase information according to the subject information is tested, Corresponding clinical testing data is obtained, and is recorded into the testing program, completes clinical trial management.
- 2. clinical trial management method as claimed in claim 1, it is characterised in that described built according to the pilot project is tried Proved recipe case, comprises the following steps：The pilot project is divided, obtains conceptual phase information；The pilot project is handled according to conceptual phase information, obtains research contents information；Two-dimentional relation combination is carried out according to the conceptual phase information and the research contents information, and passes through communications protocol and doctor Business built-in system is docked, and generates testing program.
- 3. clinical trial management method as claimed in claim 2, it is characterised in that described built according to the pilot project is tried Proved recipe case, it is further comprising the steps of：Before the pilot project is divided, according to default researcher's information and corresponding authority to described Testing items setting test type, obtain test type information.
- 4. clinical trial management method as claimed in claim 2, it is characterised in that described built according to the pilot project is tried Proved recipe case, it is further comprising the steps of：After research contents information is obtained, the research contents information is classified, obtains classifies content information.
- 5. clinical trial management method as claimed in claim 1, it is characterised in that further comprising the steps of：Tried in the relevant clinical for carrying out the research contents information according to the conceptual phase information according to the subject information After testing, cost data is obtained, book keeping operation processing is carried out according to the cost data, and generate multidimensional financial statement.
- A kind of 6. clinical trial management system, it is characterised in that including trial drug acquisition module, testing program structure module, Subject's recording module and clinical trial management module；The trial drug acquisition module, for obtaining trial drug information, according to default drug information to the trial drug Information is audited, and pilot project is established according to auditing result；The testing program builds module, for building testing program according to the pilot project；The testing program includes grinding Study carefully content information and conceptual phase information；Subject's recording module, for gathering subject information according to the testing program, the subject information is recorded Enter in the testing program；The clinical trial management module, for according to the subject information according to the conceptual phase information carry out described in grind Study carefully the relevant clinical experiment of content information, obtain corresponding clinical testing data, and record into the testing program, complete clinical Trial.
- 7. clinical trial management system as claimed in claim 6, it is characterised in that the testing program structure module includes drawing Subdivision, processing unit and assembled unit；The division unit, for the pilot project to be divided, obtain conceptual phase information；The processing unit, for the pilot project to be handled according to conceptual phase information, obtain research contents information；The assembled unit, for carrying out two-dimentional relation combination according to the conceptual phase information and the research contents information, And docked by communications protocol with medical matters built-in system, generate testing program.
- 8. clinical trial management system as claimed in claim 7, it is characterised in that the testing program builds module, also wraps Include setting unit；The setting unit, for before the pilot project is divided, according to default researcher's information and with Its corresponding authority obtains test type information to the Testing items setting test type.
- 9. clinical trial management system as claimed in claim 7, it is characterised in that the testing program builds module, also wraps Include taxon；The taxon, for after research contents information is obtained, classifying to the research contents information, being divided Class content information.
- 10. clinical trial management system as claimed in claim 6, it is characterised in that the clinical trial management module is also wrapped Include financial statement unit；The financial statement unit, for carrying out the research according to the conceptual phase information according to the subject information After the relevant clinical experiment of content information, cost data is obtained, book keeping operation processing is carried out according to the cost data, and generate more Tie up financial statement.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710724386.4A CN107480456A (en) | 2017-08-22 | 2017-08-22 | clinical trial management method and system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710724386.4A CN107480456A (en) | 2017-08-22 | 2017-08-22 | clinical trial management method and system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107480456A true CN107480456A (en) | 2017-12-15 |
Family
ID=60602160
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710724386.4A Pending CN107480456A (en) | 2017-08-22 | 2017-08-22 | clinical trial management method and system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107480456A (en) |
Cited By (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108830034A (en) * | 2018-05-25 | 2018-11-16 | 陈育聪 | A kind of medicine clinical development information processing system and its method |
| CN108932968A (en) * | 2018-05-21 | 2018-12-04 | 上海市第六人民医院 | A kind of clinical trial subjects management system |
| CN109559236A (en) * | 2018-10-27 | 2019-04-02 | 平安医疗健康管理股份有限公司 | The method and apparatus of drug reimbursement Information abnormity |
| CN109616190A (en) * | 2018-12-25 | 2019-04-12 | 天津阿贝斯努科技有限公司 | Center Ethic review management system and management method |
| CN109671478A (en) * | 2018-12-24 | 2019-04-23 | 天津阿贝斯努科技有限公司 | Clinical test case report form quality control system and method for quality control |
| CN109817290A (en) * | 2018-12-25 | 2019-05-28 | 天津阿贝斯努科技有限公司 | One clinical trial phase management system and management method |
| CN109978341A (en) * | 2019-02-28 | 2019-07-05 | 北京新研汇医药研发有限公司 | A kind of monitoring method and apparatus of clinical test |
| CN110335649A (en) * | 2019-06-04 | 2019-10-15 | 林东方 | A kind of clinical drug trials data platform based on Filemaker database |
| CN111341455A (en) * | 2020-02-10 | 2020-06-26 | 厦门茶蕊生物医药科技有限公司 | Clinical test integrated cloud platform management system, method and storage medium |
| CN111599429A (en) * | 2020-05-19 | 2020-08-28 | 苏州筑奇医药科技有限公司 | Out-of-hospital data acquisition method, equipment device and storage medium for clinical testees |
| CN111640475A (en) * | 2020-04-29 | 2020-09-08 | 上海米帝信息技术有限公司 | Management system for clinical test |
| CN111986743A (en) * | 2020-08-07 | 2020-11-24 | 上海神桥医药科技有限公司 | Medical auditing method and application thereof |
| CN112154511A (en) * | 2018-05-23 | 2020-12-29 | 希米科医疗保健机构有限公司 | Subject candidate extraction method and subject candidate extraction system |
| CN112164469A (en) * | 2020-10-14 | 2021-01-01 | 杭州卓健信息科技有限公司 | Clinical scientific research data acquisition management system |
| CN112185489A (en) * | 2020-10-14 | 2021-01-05 | 上海妙一生物科技有限公司 | Information reminding method, system, equipment and storage medium |
| CN112365940A (en) * | 2020-10-16 | 2021-02-12 | 零氪科技（北京）有限公司 | System and method for screening subjects |
| CN112655051A (en) * | 2018-05-14 | 2021-04-13 | 美国控股实验室公司 | Method and system for identifying subjects enrolled in a clinical trial |
| CN112712862A (en) * | 2019-10-24 | 2021-04-27 | 北京新研汇医药研发有限公司 | Method, device and system for generating clinical research time schedule |
| CN113035295A (en) * | 2020-10-29 | 2021-06-25 | 上海米帝信息技术有限公司 | Patient information management system |
| CN113053478A (en) * | 2021-03-11 | 2021-06-29 | 上海交通大学医学院附属新华医院 | Project and quality control system suitable for clinical test of medicine |
| CN113139727A (en) * | 2021-04-23 | 2021-07-20 | 广东丸美生物技术股份有限公司 | Cosmetic human body efficacy test subject management system and method |
| CN113314192A (en) * | 2021-06-17 | 2021-08-27 | 医渡云（北京）技术有限公司 | Clinical trial data processing system, method, device and storage medium |
| CN113707248A (en) * | 2021-08-31 | 2021-11-26 | 郑州大学第一附属医院 | Clinical trial subject examination and inspection process management system, method and computer storage medium |
| CN114334072A (en) * | 2021-12-31 | 2022-04-12 | 科临达康医药生物科技(北京)有限公司 | Method, system and equipment for establishing clinical trial development plan database |
| CN116580798A (en) * | 2023-07-13 | 2023-08-11 | 南京纳实医学科技有限公司 | Research method for dynamic and accurate clinical test selection of subject medicine |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004038560A3 (en) * | 2002-10-23 | 2004-12-09 | Capital Surini Group Internat | Systems and methods for clinical trials information management |
| CN105550532A (en) * | 2016-02-19 | 2016-05-04 | 南京迈拓医药科技有限公司 | Management system applied to medical clinical test |
| CN106295091A (en) * | 2015-05-13 | 2017-01-04 | 仁智(苏州)医学研究有限公司 | Clinical trial tracking based on cloud storage and system |
-
2017
- 2017-08-22 CN CN201710724386.4A patent/CN107480456A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004038560A3 (en) * | 2002-10-23 | 2004-12-09 | Capital Surini Group Internat | Systems and methods for clinical trials information management |
| CN106295091A (en) * | 2015-05-13 | 2017-01-04 | 仁智(苏州)医学研究有限公司 | Clinical trial tracking based on cloud storage and system |
| CN105550532A (en) * | 2016-02-19 | 2016-05-04 | 南京迈拓医药科技有限公司 | Management system applied to medical clinical test |
Non-Patent Citations (3)
| Title |
|---|
| 周克雄 等: ""药物临床试验综合信息管理系统功能设计"", 《中国药事》 * |
| 温雯 等: ""基于药物临床试验项目管理系统的临床试验全程管理"", 《中国医院管理》 * |
| 王菊勇 等: ""我院新型药物临床试验电子信息化管理系统"", 《中国新药杂志》 * |
Cited By (31)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112655051A (en) * | 2018-05-14 | 2021-04-13 | 美国控股实验室公司 | Method and system for identifying subjects enrolled in a clinical trial |
| CN108932968A (en) * | 2018-05-21 | 2018-12-04 | 上海市第六人民医院 | A kind of clinical trial subjects management system |
| CN112154511A (en) * | 2018-05-23 | 2020-12-29 | 希米科医疗保健机构有限公司 | Subject candidate extraction method and subject candidate extraction system |
| CN112154511B (en) * | 2018-05-23 | 2024-03-08 | 希米科医疗保健机构有限公司 | Subject candidate extraction method and subject candidate extraction system |
| CN108830034A (en) * | 2018-05-25 | 2018-11-16 | 陈育聪 | A kind of medicine clinical development information processing system and its method |
| CN109559236A (en) * | 2018-10-27 | 2019-04-02 | 平安医疗健康管理股份有限公司 | The method and apparatus of drug reimbursement Information abnormity |
| CN109559236B (en) * | 2018-10-27 | 2023-08-08 | 深圳平安医疗健康科技服务有限公司 | Method and device for canceling information abnormality of medicines |
| CN109671478A (en) * | 2018-12-24 | 2019-04-23 | 天津阿贝斯努科技有限公司 | Clinical test case report form quality control system and method for quality control |
| CN109817290A (en) * | 2018-12-25 | 2019-05-28 | 天津阿贝斯努科技有限公司 | One clinical trial phase management system and management method |
| CN109616190A (en) * | 2018-12-25 | 2019-04-12 | 天津阿贝斯努科技有限公司 | Center Ethic review management system and management method |
| CN109978341A (en) * | 2019-02-28 | 2019-07-05 | 北京新研汇医药研发有限公司 | A kind of monitoring method and apparatus of clinical test |
| CN110335649A (en) * | 2019-06-04 | 2019-10-15 | 林东方 | A kind of clinical drug trials data platform based on Filemaker database |
| CN110335649B (en) * | 2019-06-04 | 2024-01-16 | 林东方 | Clinical medicine test data platform based on Filemaker database |
| CN112712862A (en) * | 2019-10-24 | 2021-04-27 | 北京新研汇医药研发有限公司 | Method, device and system for generating clinical research time schedule |
| CN111341455A (en) * | 2020-02-10 | 2020-06-26 | 厦门茶蕊生物医药科技有限公司 | Clinical test integrated cloud platform management system, method and storage medium |
| CN111640475A (en) * | 2020-04-29 | 2020-09-08 | 上海米帝信息技术有限公司 | Management system for clinical test |
| CN111599429A (en) * | 2020-05-19 | 2020-08-28 | 苏州筑奇医药科技有限公司 | Out-of-hospital data acquisition method, equipment device and storage medium for clinical testees |
| CN111599429B (en) * | 2020-05-19 | 2023-11-03 | 中科筑奇医药科技(苏州)有限公司 | Clinical subject off-site data acquisition method, equipment device and storage medium |
| CN111986743A (en) * | 2020-08-07 | 2020-11-24 | 上海神桥医药科技有限公司 | Medical auditing method and application thereof |
| CN112185489A (en) * | 2020-10-14 | 2021-01-05 | 上海妙一生物科技有限公司 | Information reminding method, system, equipment and storage medium |
| CN112164469A (en) * | 2020-10-14 | 2021-01-01 | 杭州卓健信息科技有限公司 | Clinical scientific research data acquisition management system |
| CN112365940A (en) * | 2020-10-16 | 2021-02-12 | 零氪科技（北京）有限公司 | System and method for screening subjects |
| CN113035295A (en) * | 2020-10-29 | 2021-06-25 | 上海米帝信息技术有限公司 | Patient information management system |
| CN113053478A (en) * | 2021-03-11 | 2021-06-29 | 上海交通大学医学院附属新华医院 | Project and quality control system suitable for clinical test of medicine |
| CN113139727A (en) * | 2021-04-23 | 2021-07-20 | 广东丸美生物技术股份有限公司 | Cosmetic human body efficacy test subject management system and method |
| CN113139727B (en) * | 2021-04-23 | 2024-01-16 | 广东丸美生物技术股份有限公司 | Cosmetic human body efficacy test subject management system and method |
| CN113314192A (en) * | 2021-06-17 | 2021-08-27 | 医渡云（北京）技术有限公司 | Clinical trial data processing system, method, device and storage medium |
| CN113707248A (en) * | 2021-08-31 | 2021-11-26 | 郑州大学第一附属医院 | Clinical trial subject examination and inspection process management system, method and computer storage medium |
| CN114334072A (en) * | 2021-12-31 | 2022-04-12 | 科临达康医药生物科技(北京)有限公司 | Method, system and equipment for establishing clinical trial development plan database |
| CN116580798A (en) * | 2023-07-13 | 2023-08-11 | 南京纳实医学科技有限公司 | Research method for dynamic and accurate clinical test selection of subject medicine |
| CN116580798B (en) * | 2023-07-13 | 2023-10-20 | 南京纳实医学科技有限公司 | Research method for dynamic and accurate clinical test selection of subject medicine |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN107480456A (en) | clinical trial management method and system | |
| CN1714352B (en) | Systems and methods for clinical trials information management | |
| Aydin et al. | Creating and analyzing a statewide nursing quality measurement database | |
| Sanz et al. | Co-design for people-centred care digital solutions: a literature review | |
| Altuwaijri | Electronic-health in saudi arabia | |
| Larson et al. | Managing the quality of health care | |
| CN105556513A (en) | System and methods for personalized clinical decision support tools | |
| Alanazi et al. | Factors influencing pharmacists' intentions to use Pharmacy Information Systems | |
| CN107610745A (en) | The central pharmacy management method and system of trial drug | |
| CN111640475A (en) | Management system for clinical test | |
| Lin et al. | Learning from Taiwan patient-safety reporting system | |
| Marchenko et al. | Sources of safety data and statistical strategies for design and analysis: real world insights | |
| McNair et al. | Use of RWE to inform regulatory, public health policy, and intervention priorities for the developing world | |
| Lentz et al. | Designing, conducting, monitoring, and analyzing data from pragmatic randomized clinical trials: proceedings from a multi-stakeholder think tank meeting | |
| Mann et al. | Adverse drug events and medication errors in psychiatry: methodological issues regarding identification and classification | |
| Simoens et al. | Review of the cost-effectiveness of interventions to improve seamless care focusing on medication | |
| Qureshi et al. | Mobile access for patient centered care: The challenges of activating knowledge through health information technology | |
| Cimino et al. | Building a competitive infrastructure to support clinical research in healthcare institution | |
| Ives et al. | Resilience and ongoing quality care for cancer clinical trials during COVID‐19: experience from a tertiary hospital in Australia | |
| Bouwman-Boer et al. | Pharmaceutical quality systems | |
| Syah et al. | Lean Six Sigma Concept in The Health Service Process in The Universal Health Coverage of BPJS Healthcare (Healthcare and Social Security Agency) | |
| Shen et al. | Development of an integrated and comprehensive clinical trial process management system | |
| KR102052066B1 (en) | Remote CRO system and method using block-chain | |
| Ndagije et al. | Drug safety in Africa: a review of systems and resources for pharmacovigilance | |
| Delameillieure et al. | Electronically monitored medication adherence in idiopathic pulmonary fibrosis: prevalence, predictors and outcomes |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20171215 |
|
| RJ01 | Rejection of invention patent application after publication |