CN105678084A - Data processing method and equipment based on good clinical practice (GCP) - Google Patents
Data processing method and equipment based on good clinical practice (GCP) Download PDFInfo
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- CN105678084A CN105678084A CN201610018001.8A CN201610018001A CN105678084A CN 105678084 A CN105678084 A CN 105678084A CN 201610018001 A CN201610018001 A CN 201610018001A CN 105678084 A CN105678084 A CN 105678084A
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Abstract
The invention provides a data processing method and equipment based on a good clinical practice (GCP). The method comprises the steps that trial data which is input by drug subjects and/or medical workers and generated according to clinical trials of a specified drug is collected in real time; according to trial item identifications contained in the trial data, a data storage area used for storing the trial data corresponding to each trial item identification is determined, and the collected trial data is stored in the data storage areas; a clinical trial result of the specified drug is analyzed by utilizing the trial data stored in the data storage areas. The trial data generated by different users is collected in real time and stored in a partitioned mode according to trial items, not only is effective integration of different trial data guaranteed, but also the clinical trial result of the specified drug can be analyzed rapidly and accurately on the basis of the trial data in different storage areas, and the data processing efficiency of a drug clinical trial quality specification system is promoted.
Description
Technical field
The present invention relates to field of computer technology, particularly relate to a kind of (English: GoodClinicalPractice based on the clinical drug trial specifications of quality; Abbreviation: data processing method GCP) and equipment.
Background technology
GCP (GCP), is the standard regulation of clinical drug trial overall process, including conceptual design, organizing and implementing, inspection, inspection, record, analysis and summary and report.
Clinical trial for a kind of medicine can carry out in multiple different test centers, it is also possible to participated in the clinical trial of this medicine by multiple different patients. In existing GCP system, the GCP system that each test center uses is an independent GCP system, clinical testing data for same medicine relatively disperses, can not the performance of relatively accurate this medicine of expression with this analysis of experiments result for this medicine obtained.
In sum, one is needed badly (English: GoodClinicalPractice based on the clinical drug trial specifications of quality; Abbreviation: data processing method GCP), the relatively scattered problem of clinical testing data to solve prior art Chinese medicine.
Summary of the invention
In view of this, one is embodiments provided (English: GoodClinicalPractice based on the clinical drug trial specifications of quality; Abbreviation: data processing method GCP), the relatively scattered problem of clinical testing data to solve prior art Chinese medicine.
A kind of data processing method based on the clinical drug trial specifications of quality, including:
The test data produced for specific drug clinical trial of Real-time Collection medicine experimenter and/or medical personnel's input;
According to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and the described test data collected is stored to described data storage area;
Utilize the described test data of storage in described data storage area, analyze the clinical test results of described specific drug.
Alternatively, the described test data collected is stored to described data storage area, including:
Data content according to described test data, it is determined that the access rights of described test data;
The access rights of described test data and described test data are stored to described data storage area.
Alternatively, described method also includes:
Collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, send electronic signature request, wherein, described electronic signature request is for indicating medicine experimenter and/or medical personnel that the test data for specific drug clinical trial generation of input is confirmed.
Alternatively, described method also includes:
Collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, to collect for specific drug clinical trial produce test data be encrypted;
The described test data collected is stored to described data storage area, including:
Described test data after encryption is stored to described data storage area.
Alternatively, described method also includes:
Receive the data access request that user sends, wherein, described data access request comprises the accounts information of described user;
The corresponding relation between accounts information and access rights according to default user, it is determined that the access rights that the accounts information of the described user received is corresponding, and the data content of test data corresponding for described access rights is pushed to described user.
Alternatively, the data content of test data corresponding for described access rights is pushed to described user, including:
According to the time that the test data that described access rights are corresponding stores, utilize the displaying pattern set, test data corresponding for described access rights is showed described user successively.
Alternatively, described method also includes:
When determining the time arriving the new test data of collection, sending reminder message to described medicine experimenter and/or described medical personnel, wherein, described reminder message is for pointing out described medicine experimenter and/or described medical personnel to input new test data.
A kind of data handling equipment based on the clinical drug trial specifications of quality, including:
Collecting unit, for the test data produced for specific drug clinical trial that Real-time Collection medicine experimenter and/or medical personnel input;
Memory element, for according to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and store the described test data collected to described data storage area;
Analytic unit, for utilizing the described test data of storage in described data storage area, analyzes the clinical test results of described specific drug.
Alternatively, the described test data collected is stored to described data storage area by described memory element, including:
Data content according to described test data, it is determined that the access rights of described test data;
The access rights of described test data and described test data are stored to described data storage area.
Alternatively, described data process and also include: transmitting element, wherein:
Described transmitting element, for collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, send electronic signature request, wherein, described electronic signature request is for indicating medicine experimenter and/or medical personnel that the test data for specific drug clinical trial generation of input is confirmed.
Alternatively, described data process and also include: ciphering unit, wherein:
Described ciphering unit, for collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, to collect for specific drug clinical trial produce test data be encrypted;
Described memory element, specifically for storing the described test data after encryption to described data storage area.
Alternatively, described data handling equipment also includes: receive unit and push unit, wherein:
Described reception unit, for receiving the data access request that user sends, wherein, comprises the accounts information of described user in described data access request;
Described push unit, for the corresponding relation between accounts information and the access rights according to the user preset, determine the access rights that the accounts information of the described user received is corresponding, and the data content of test data corresponding for described access rights is pushed to described user.
Alternatively, the data content of test data corresponding for described access rights is pushed to described user by described push unit, including:
According to the time that the test data that described access rights are corresponding stores, utilize the displaying pattern set, test data corresponding for described access rights is showed described user successively.
Alternatively, described data process and also include: reminding unit, wherein:
Described reminding unit, for when determining the time arriving the new test data of collection, sending reminder message to described medicine experimenter and/or described medical personnel, wherein, described reminder message is for pointing out described medicine experimenter and/or described medical personnel to input new test data.
The present invention has the beneficial effect that:
The test data produced for specific drug clinical trial of embodiment of the present invention Real-time Collection medicine experimenter and/or medical personnel's input; According to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and the described test data collected is stored to described data storage area; Utilize the described test data of storage in described data storage area, analyze the clinical test results of described specific drug. By the data processing method based on the clinical drug trial specifications of quality that the embodiment of the present invention provides, the test data that Real-time Collection different user produces, and the test data of generation is carried out partitioned storage according to pilot project, both ensure that effectively integrating of different tests data, the clinical test results of specific drug can also be analyzed based on the test data in different memory areas rapidly and accurately, improve the data-handling efficiency of clinical drug trial specifications of quality system.
Accompanying drawing explanation
In order to be illustrated more clearly that the technical scheme in the embodiment of the present invention, below the accompanying drawing used required during embodiment is described is briefly introduced, apparently, accompanying drawing in the following describes is only some embodiments of the present invention, for those of ordinary skill in the art, under the premise not paying creative work, it is also possible to obtain other accompanying drawing according to these accompanying drawings.
Fig. 1 for the embodiment of the present invention provide a kind of based on the schematic flow sheet of data processing method;
Fig. 2 for the embodiment of the present invention provide a kind of based on the structural representation of data handling equipment;
Fig. 3 for the embodiment of the present invention provide a kind of based on the structural representation of data handling equipment.
Detailed description of the invention
In order to realize the purpose of the present invention, embodiments provide a kind of data processing method based on the clinical drug trial specifications of quality and equipment, the test data produced for specific drug clinical trial of Real-time Collection medicine experimenter and/or medical personnel's input;According to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and the described test data collected is stored to described data storage area; Utilize the described test data of storage in described data storage area, analyze the clinical test results of described specific drug. By the data processing method based on the clinical drug trial specifications of quality that the embodiment of the present invention provides, the test data that Real-time Collection different user produces, and the test data of generation is carried out partitioned storage according to pilot project, both ensure that effectively integrating of different tests data, the clinical test results of specific drug can also be analyzed based on the test data in different memory areas rapidly and accurately, improve the data-handling efficiency of clinical drug trial specifications of quality system.
Below in conjunction with Figure of description, each embodiment of the present invention is described in further detail. Obviously, described embodiment is only a part of embodiment of the present invention, rather than whole embodiments. Based on the embodiment in the present invention, all other embodiments that those of ordinary skill in the art obtain under not making creative work premise, broadly fall into the scope of protection of the invention.
Fig. 1 for the embodiment of the present invention provide a kind of based on the schematic flow sheet of data processing method. Described method can be as follows.
Step 101: the test data produced for specific drug clinical trial of Real-time Collection medicine experimenter and/or medical personnel's input.
In a step 101, owing to carrying out clinical trial for specific drug, can be started by different test centers simultaneously, can also be respectively started by different test centers, then different tests center needs the health care worker determined medicine experimenter respectively and these medicines experimenter is instructed. So at different tests center, first the test data produced for specific drug clinical trial of medicine experimenter and health care worker collection that these medicines experimenter is instructed is uploaded in the data base of the clinical drug trial specifications of quality of place test center. In embodiments of the present invention, the data base of the clinical drug trial specifications of quality of test center can be referred to as data word bank.
The data handling equipment that the embodiment of the present invention provides possesses the ability of Real-time Collection test data from data word bank, and the data of the data word bank that the clinical drug trial specifications of quality at such different tests center is corresponding can be integrated in data handling equipment automatically.
Alternatively, in embodiments of the present invention, described method also includes:
Collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, send electronic signature request.
Wherein, described electronic signature request is for indicating medicine experimenter and/or medical personnel that the test data for specific drug clinical trial generation of input is confirmed.
Specifically, data handling equipment may indicate that the data word bank sending test data sends electronic signature request to medicine experimenter and/or medical personnel, it is desirable to the test data of its input is confirmed by medicine experimenter and/or medical personnel.
Here the electronic signature protocol format that uses of request or transmission means can adopt any one that prior art Chinese medicine clinical trial specifications of quality system supports, are not specifically limited in the embodiment of the present application.
Alternatively, in embodiments of the present invention, described method also includes:
Collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, to collect for specific drug clinical trial produce test data be encrypted.
In order to ensure the safety of the test data of storage in data handling equipment, it is possible to adopt existing encryption method that the test data collected is encrypted, for instance: irreversible AES, rivest, shamir, adelman etc.
Alternatively, in embodiments of the present invention, described method also includes:
For the test data collected, can according to the data content of test data, the test data respectively collected arranges different access rights, such as: if the test data the collected various physiological characteristic data that are medicine experimenter in using specific drug process, then for the access rights of its setting can be medicine experimenter and medical personnel all addressable; If the clinical analysis result that the test data collected is medical personnel, then the access rights for its setting can be different grades of health care worker.
Step 102: according to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and the described test data collected is stored to described data storage area.
In a step 102, for the convenience that safety and the subsequent analysis of guarantee test data use, the test data collected is stored by the mode adopting partitioned storage district, subregion is carried out according to pilot project by the memory space in data handling equipment, obtain different memory blocks, and set up the mapping relations between the mark of memory block and pilot project mark.
So when the test data collected, can according to the pilot project mark comprised in test data, and the mapping relations between the mark of the memory block pre-build and pilot project mark, determine the data storage area for storing test data corresponding to described pilot project mark, and the described test data collected is stored to described data storage area.
It should be noted that, owing to clinical drug trial specifications of quality system not only realizes the clinical trial of a kind of specific drug in the same time, the clinical trial of multiple specific drug can be realized, so in clinical drug trial specifications of quality system, one pilot project mark can be set for the clinical trial of each specific drug, so gather medicine experimenter and/or medical personnel when the test data that input produces for specific drug clinical trial, it is necessary to first determine the pilot project mark that test data is corresponding. The identity being uniquely capable of identify that this pilot project that pilot project mark can be pilot project title or system generates according to pilot project title in the embodiment of the present invention, does not limit here; The mark of the memory block in the embodiment of the present invention can be the storage address information of memory block, it is also possible to is other information, does not limit here.
Alternatively, in inventive embodiments, if the test data collected is encrypted test data, then the described test data after encryption is stored to described data storage area.
Alternatively, in inventive embodiments, the described test data collected is stored to described data storage area, including:
Data content according to described test data, it is determined that the access rights of described test data;
The access rights of described test data and described test data are stored to described data storage area.
Alternatively, in inventive embodiments, the described test data collected is stored to described data storage area, including:
The described test data collected is sent and stores to high in the clouds.
Step 103: utilize the described test data of storage in described data storage area, analyze the clinical test results of described specific drug.
In step 103, for a pilot project, it is possible to use the test data of storage in the data storage area that this pilot project is corresponding, the clinical test results of specific drug is analyzed.
Alternatively, it is also possible to revise existing testing program etc. for clinical test results.
Alternatively, in embodiments of the present invention, described method also includes:
Receive the data access request that user sends, wherein, described data access request comprises the accounts information of described user;
The corresponding relation between accounts information and access rights according to default user, it is determined that the access rights that the accounts information of the described user received is corresponding, and the data content of test data corresponding for described access rights is pushed to described user.
Alternatively, the data content of test data corresponding for described access rights is pushed to described user, including:
According to the time that the test data that described access rights are corresponding stores, utilize the displaying pattern set, test data corresponding for described access rights is showed described user successively.
The displaying pattern here preset at can comprise schedule and show pattern, diagnosis and treatment parameter display pattern etc.
Alternatively, in embodiments of the present invention, described method also includes:
When determining the time arriving the new test data of collection, sending reminder message to described medicine experimenter and/or described medical personnel, wherein, described reminder message is for pointing out described medicine experimenter and/or described medical personnel to input new test data.
Owing to the data handling equipment described in the embodiment of the present invention can support that multiple intelligent terminal is accessed by network insertion, so when determining the time arriving the new test data of collection, reminder message can be sent on the intelligent terminal that extremely described medicine experimenter and/or described medical personnel use, to realize the purpose pointing out described medicine experimenter and/or described medical personnel to input new test data; At the same time it can also be receive the test data of the intelligent terminal transmission used from described medicine experimenter and/or described medical personnel.
By the technical scheme that the embodiment of the present invention provides, the test data produced for specific drug clinical trial of Real-time Collection medicine experimenter and/or medical personnel's input; According to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and the described test data collected is stored to described data storage area; Utilize the described test data of storage in described data storage area, analyze the clinical test results of described specific drug. When the test data that Real-time Collection different user produces, the test data of generation is carried out partitioned storage according to pilot project, both ensure that effectively integrating of different tests data, the clinical test results of specific drug can also be analyzed based on the test data in different memory areas rapidly and accurately, improve the data-handling efficiency of clinical drug trial specifications of quality system.
The structural representation of a kind of data handling equipment based on the clinical drug trial specifications of quality that Fig. 2 provides for the embodiment of the present invention.Described data handling equipment includes: collecting unit 21, memory element 22 and analytic unit 23, wherein:
Collecting unit 21, for the test data produced for specific drug clinical trial that Real-time Collection medicine experimenter and/or medical personnel input;
Memory element 22, for according to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and store the described test data collected to described data storage area;
Analytic unit 23, for utilizing the described test data of storage in described data storage area, analyzes the clinical test results of described specific drug.
Alternatively, the described test data collected is stored to described data storage area by described memory element 22, including:
Data content according to described test data, it is determined that the access rights of described test data;
The access rights of described test data and described test data are stored to described data storage area.
Alternatively, described data process and also include: transmitting element 24, wherein:
Described transmitting element 24, for collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, send electronic signature request, wherein, described electronic signature request is for indicating medicine experimenter and/or medical personnel that the test data for specific drug clinical trial generation of input is confirmed.
Alternatively, described data process and also include: ciphering unit 25, wherein:
Described ciphering unit 25, for collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, to collect for specific drug clinical trial produce test data be encrypted;
Described memory element 22, specifically for storing the described test data after encryption to described data storage area.
Alternatively, described data handling equipment also includes: receive unit 26 and push unit 27, wherein:
Described reception unit 26, for receiving the data access request that user sends, wherein, comprises the accounts information of described user in described data access request;
Described push unit 27, for the corresponding relation between accounts information and the access rights according to the user preset, determine the access rights that the accounts information of the described user received is corresponding, and the data content of test data corresponding for described access rights is pushed to described user.
Alternatively, the data content of test data corresponding for described access rights is pushed to described user by described push unit 27, including:
According to the time that the test data that described access rights are corresponding stores, utilize the displaying pattern set, test data corresponding for described access rights is showed described user successively.
Alternatively, described data process and also include: reminding unit 28, wherein:
Described reminding unit 28, for when determining the time arriving the new test data of collection, sending reminder message to described medicine experimenter and/or described medical personnel, wherein, described reminder message is for pointing out described medicine experimenter and/or described medical personnel to input new test data.
It should be noted that the equipment that the embodiment of the present invention provides can adopt hardware mode to realize, it would however also be possible to employ software mode realizes, and is not specifically limited here.
The structural representation of a kind of data handling equipment based on the clinical drug trial specifications of quality that Fig. 3 provides for the embodiment of the present invention.
The data handling equipment that the embodiment of the present invention provides adopts typical J2EE three-tier architecture, and core frame adopts the MVC framework of SSH, and front end adopts the response type design pattern of HTML5+CSS3+JQuery to realize.
The cloud computing framework of the data handling equipment that the embodiment of the present invention provides all adopts the Open Source Framework of OpenSource: 1) by MariaDB cluster to be responsible for core data storage, support level extends; 2) distributed concentration buffer memory is realized with typical Redis cluster; 3) extension of application cluster is met by Zookeeper; 4) file etc. are stored in the large data center of Hadoop (HDFS); 5) full-text search adopts ElasticSearch to support.
Mainly achieve following Core Feature in the application: 1) mechanism, project and personal management; 2) the testing program management of each mechanism project; 3) experimenter's schedule management; 4) experimenter's essential information and enter group and the management such as de-group; 5) achieve gracefulness schedule flexibly to show, it is provided that the various modes such as day, week, the moon; 6) provide experimenter to fill in daily record, PI carry out the information such as AE/SAE management; 7) the multiple alerting pattern such as note, wechat is provided; 8) PI, Sub-PI, mechanism is provided to do clinical many roles such as personnel, experimenter and participate in; 9) electronic signature that Operation Log is real-time is provided; 10) access stencil of the multiple terminals such as wechat, mobile phone, computer is provided; 11) providing multi-level safety mechanism, be first to user authority management, different level authority users can not go beyond one's commission and transfer related data; Secondly disparity items data septal area storage; 3rd high in the clouds data are stored in national high secure data storage center. We from network, be applied to the many-sides such as data storage and guarantee data security; 12) providing data interlock function, data are carried out offline storage after formally terminating by project, and data cannot be modified by user again.
It will be understood by those skilled in the art that embodiments of the invention can be provided as method, device (equipment) or computer program. Therefore, the present invention can adopt the form of complete hardware embodiment, complete software implementation or the embodiment in conjunction with software and hardware aspect. And, the present invention can adopt the form at one or more upper computer programs implemented of computer-usable storage medium (including but not limited to disk memory, CD-ROM, optical memory etc.) wherein including computer usable program code.
The present invention is that flow chart and/or block diagram with reference to method according to embodiments of the present invention, device (equipment) and computer program describe. It should be understood that can by the combination of the flow process in each flow process in computer program instructions flowchart and/or block diagram and/or square frame and flow chart and/or block diagram and/or square frame. These computer program instructions can be provided to produce a machine to the processor of general purpose computer, special-purpose computer, Embedded Processor or other programmable data processing device so that the instruction performed by the processor of computer or other programmable data processing device is produced for realizing the device of function specified in one flow process of flow chart or multiple flow process and/or one square frame of block diagram or multiple square frame.
These computer program instructions may be alternatively stored in and can guide in the computer-readable memory that computer or other programmable data processing device work in a specific way, the instruction making to be stored in this computer-readable memory produces to include the manufacture of command device, and this command device realizes the function specified in one flow process of flow chart or multiple flow process and/or one square frame of block diagram or multiple square frame.
These computer program instructions also can be loaded in computer or other programmable data processing device, make on computer or other programmable devices, to perform sequence of operations step to produce computer implemented process, thus the instruction performed on computer or other programmable devices provides for realizing the step of function specified in one flow process of flow chart or multiple flow process and/or one square frame of block diagram or multiple square frame.
Although preferred embodiments of the present invention have been described, but those skilled in the art are once know basic creative concept, then these embodiments can be made other change and amendment. So, claims are intended to be construed to include preferred embodiment and fall into all changes and the amendment of the scope of the invention.
Obviously, the present invention can be carried out various change and modification without deviating from the spirit and scope of the present invention by those skilled in the art. So, if these amendments of the present invention and modification belong within the scope of the claims in the present invention and equivalent technologies thereof, then the present invention is also intended to comprise these change and modification.
Claims (10)
1. the data processing method based on the clinical drug trial specifications of quality, it is characterised in that including:
The test data produced for specific drug clinical trial of Real-time Collection medicine experimenter and/or medical personnel's input;
According to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and the described test data collected is stored to described data storage area;
Utilize the described test data of storage in described data storage area, analyze the clinical test results of described specific drug.
2. data processing method as claimed in claim 1, it is characterised in that the described test data collected is stored to described data storage area, including:
Data content according to described test data, it is determined that the access rights of described test data;
The access rights of described test data and described test data are stored to described data storage area.
3. data processing method as claimed in claim 1, it is characterised in that described method also includes:
Collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, send electronic signature request, wherein, described electronic signature request is for indicating medicine experimenter and/or medical personnel that the test data for specific drug clinical trial generation of input is confirmed.
4. data processing method as claimed in claim 1, it is characterised in that described method also includes:
Collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, to collect for specific drug clinical trial produce test data be encrypted;
The described test data collected is stored to described data storage area, including:
Described test data after encryption is stored to described data storage area.
5. data processing method as claimed in claim 1, it is characterised in that described method also includes:
Receive the data access request that user sends, wherein, described data access request comprises the accounts information of described user;
The corresponding relation between accounts information and access rights according to default user, it is determined that the access rights that the accounts information of the described user received is corresponding, and the data content of test data corresponding for described access rights is pushed to described user.
6. data processing method as claimed in claim 5, it is characterised in that the data content of test data corresponding for described access rights is pushed to described user, including:
According to the time that the test data that described access rights are corresponding stores, utilize the displaying pattern set, test data corresponding for described access rights is showed described user successively.
7. data processing method as claimed in claim 1, it is characterised in that described method also includes:
When determining the time arriving the new test data of collection, sending reminder message to described medicine experimenter and/or described medical personnel, wherein, described reminder message is for pointing out described medicine experimenter and/or described medical personnel to input new test data.
8. the data handling equipment based on the clinical drug trial specifications of quality, it is characterised in that including:
Collecting unit, for the test data produced for specific drug clinical trial that Real-time Collection medicine experimenter and/or medical personnel input;
Memory element, for according to the pilot project mark comprised in described test data, it is determined that for storing the data storage area of test data corresponding to described pilot project mark, and store the described test data collected to described data storage area;
Analytic unit, for utilizing the described test data of storage in described data storage area, analyzes the clinical test results of described specific drug.
9. data handling equipment as claimed in claim 8, it is characterised in that the described test data collected is stored to described data storage area by described memory element, including:
Data content according to described test data, it is determined that the access rights of described test data;
The access rights of described test data and described test data are stored to described data storage area.
10. data handling equipment as claimed in claim 8, it is characterised in that described data process and also include: transmitting element, wherein:
Described transmitting element, for collect medicine experimenter and/or medical personnel input for specific drug clinical trial produce test data time, send electronic signature request, wherein, described electronic signature request is for indicating medicine experimenter and/or medical personnel that the test data for specific drug clinical trial generation of input is confirmed.
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