CN115691737A - Clinical trial electronic data management system and management method - Google Patents
Clinical trial electronic data management system and management method Download PDFInfo
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Abstract
The embodiment of the application provides a clinical trial electronic data management system and a clinical trial electronic data management method, which integrate a central stochastic system and comprise a data layer and an application layer which are connected with each other, wherein the data layer stores clinical trial data, and the application layer comprises: the system comprises a project management module, a subject module, a logic check module, a central random module, a follow-up design module and a research management module, wherein the project management module, the subject module, the logic check module, the central random module, the follow-up design module and the research management module are connected with one another. The clinical test electronic data management system can electronically acquire and manage clinical data and complete the processes of online randomization, data recording, logic check, data questioning and the like in a cloud platform.
Description
Technical Field
The application relates to the technical field of medical treatment, in particular to a clinical trial electronic data management system and a clinical trial electronic data management method.
Background
During the experiment process of clinical research, various data need to be recorded, and project progress and experiment effect are deduced through the recorded data. In a traditional clinical test, test data is often recorded and sorted by manual papering, manual recording is inevitable to cause errors, and a great deal of time is also required for checking the correctness of the data in a great amount of data of the whole test. The appearance of an EDC System (Electronic Data Capture System, abbreviated as EDC) replaces paper-based recording of clinical trial Data, and is mainly used for collecting and transmitting the clinical trial Data. The central stochastic system is a computer information system used for services such as randomized distribution, subject management, drug management and the like in clinical trials. The traditional EDC system and the central random system realize paperless clinical test, improve test execution efficiency to a certain extent, and because the test functions which can be completed by the two systems are different, a worker needs to switch the two systems back and forth in the operation, so that the test efficiency is influenced.
Disclosure of Invention
In view of this, the embodiment of the present application provides a clinical test electronic data management system and a clinical test electronic data management method, which can electronically acquire and manage clinical data, complete processes such as online randomization, data recording, logic checking, data questioning and the like in a cloud platform, do not need to switch systems, and improve test efficiency.
In a first aspect, an embodiment of the present application provides a clinical trial electronic data management system, which integrates a central stochastic system, and includes a data layer and an application layer that are connected to each other, where the data layer stores clinical trial data, and the application layer includes:
the project management module is used for managing different test projects, test centers related to the test projects, central users of the test centers and authorities of the central users;
the test center is used for screening test subjects, randomly sampling the test subjects through an electronic envelope by combining a central random system, and marking all operations of the test subjects by the central user;
the logic checking module is used for setting a checking rule, automatically and logically checking all data variables input by the central user through a logic algorithm and putting forward a logic question;
a central randomization module for performing a stochastic screening of the subjects of the trial project into groups;
the follow-up design module is used for automatically crawling and processing the data in the data layer so as to remind each subject of visit;
the research management module is used for checking the completion degree of the test project by analyzing the test data;
wherein the project management module, the subject module, the logic check module, the central randomization module, the follow-up design module, and the study management module are interconnected.
In the clinical trial electronic data management system provided by the application, the logically checked data variables comprise single variables and combined variables, the logically checking module further comprises a data question module, the data question module is used for making a question for the data variables subjected to automatic logical checking, and the data question module comprises an input question, a missing question, an abnormal value question, an out-of-window question, a data out-of-range question and a manual question.
In the clinical trial electronic data management system provided by the application, the completion degree comprises the group completion rate, the group entry progress of the trial center subject, the follow-up visit completion rate, the question completion rate, adverse events and serious adverse event statistics.
In the clinical trial electronic data management system provided herein, the randomized screening into groups includes simple randomization, block randomization, hierarchical randomization, and dynamic randomization.
In the clinical trial electronic data management system provided by the application, the subject module comprises screening grouping, viewing a case report form, printing a case report form, collecting a case report form, exporting follow-up records, bad event records and trace tracing.
In a second aspect, an embodiment of the present application provides a clinical trial electronic data management method, which is implemented by the clinical trial electronic data management system according to any one of the first aspect, and includes:
generating a test scheme according to the test item information and the test center information;
collecting and storing subject information, and randomly grouping the subjects;
designing a case report table for the grouped subjects, wherein the case report table is used for recording follow-up visit records of the subjects;
and checking and controlling the progress of the test project at any time according to the case report table.
In the clinical trial electronic data management method provided by the present application, the designing a case report table for the grouped subjects, the case report table being used for recording follow-up records of the subjects, includes:
formulating a follow-up model for the subject according to the test protocol;
and designing the case report table according to the follow-up model.
In the clinical trial electronic data management method provided by the present application, after the designing the case report form according to the follow-up model, the method further includes:
collecting follow-up data in the case report table;
viewing, printing, and/or exporting the case report form.
In the clinical trial electronic data management method provided by the application, the acquiring follow-up data in the case report table further includes:
recording adverse events in the follow-up process;
carrying out logic check on the follow-up visit data and generating a question;
trace tracing is carried out on the whole follow-up visit period.
In a third aspect, the present invention provides a computer-readable storage medium having stored thereon a computer program which, when run on a computer, causes the computer to perform a method of clinical trial electronic data management as provided in the second aspect, herein.
To sum up, the embodiment of the present application provides a clinical trial electronic data management system, which integrates a central stochastic system, and includes a data layer and an application layer that are connected to each other, where the data layer stores clinical trial data, and the application layer includes: the project management module is used for managing different test projects, test centers related to the test projects, central users of the test centers and authorities of the central users; the test center is used for screening test subjects, randomly sampling the test subjects by combining the central random system through an electronic envelope, and leaving all the operation of the test subjects by the test center; the logic checking module is used for setting a checking rule, automatically and logically checking all data variables input by a central user through a logic algorithm and putting forward a logic question; the central random module is used for randomly screening subjects of the test items into groups; the follow-up visit design module is used for automatically crawling and processing data in the data layer so as to remind each subject of visit; the research management module is used for checking the completion degree of the test project by analyzing the test data; the system comprises a project management module, a subject module, a logic check module, a central random module, a follow-up visit design module and a research management module, wherein the project management module, the subject module, the logic check module, the central random module, the follow-up visit design module and the research management module are connected with one another. The clinical test electronic data management system can electronically acquire and manage clinical data and complete the processes of on-line randomization, data recording, logic check, data questioning and the like in a cloud platform.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic illustration of a clinical trial electronic data management system provided by an embodiment of the present application;
FIG. 2 is a flow chart of a clinical trial electronic data management method provided by an embodiment of the application.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The terms "first" and "second", etc. in this application are used to distinguish between different objects and not to describe a particular order. Furthermore, "include" and "have" and any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, system, article, or apparatus that comprises a list of steps or modules is not limited to the listed steps or modules but may alternatively include other steps or modules not listed or inherent to such process, method, article, or apparatus.
Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearances of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. It is explicitly and implicitly understood by one skilled in the art that the embodiments described herein may be combined with other embodiments.
Next, a clinical trial electronic data management system and a clinical trial electronic data management method provided by the embodiment of the present application will be described.
Referring to fig. 1, fig. 1 is a schematic diagram of a clinical trial electronic data management system 100 provided in an embodiment of the present application, which integrates a central stochastic system, and includes a data layer 12 and an application layer 11 connected to each other, where the data layer 12 stores clinical trial data, and the application layer 11 includes:
the project management module 111 is used for managing different test projects, test centers related to the test projects, central users of the test centers and authorities of the central users;
the test subject module 112 is used for screening test subjects by the test center, completing random sampling of the test subjects by combining a central random system through an electronic envelope, and leaving all operations of the test subjects by the central user;
the logic checking module 113 is used for setting a checking rule, automatically and logically checking all data variables input by a central user through a logic algorithm and putting forward a logic question;
a central randomization module 114 for performing a random screening grouping for the subjects of the trial project;
the follow-up design module 115 automatically crawls and processes data in the data layer so as to remind each subject of visit;
the research management module 116 is used for checking the completion degree of the test project by analyzing the test data;
wherein, the project management module 111, the subject module 112, the logic check module 113, the central random module 114, the follow-up design module 115 and the study management module 116 are connected with each other.
In the system, data transmission is realized through a client/server communication method, the server adopts a cloud server, clinical test data is stored in the cloud, the data transmission is not limited by a region, the processes of online random, data recording, logic check, data questioning and the like are directly completed at the cloud server, and the promotion of clinical research projects is promoted through multi-terminal data communication. In the project management module, different test projects correspond to different test centers, corresponding center users are arranged in the different test centers, and the different center users set up corresponding operation authorities, so that the clinical test data management system can simultaneously manage data of a plurality of test projects. The subject module 112 performs subject data entry and screening, real-time entry and automatic system storage, and then the central random module 114 performs random grouping or online screening on the subjects to be grouped, and the subjects after screening can operate subject information in a subject list, a subject group and a subject hierarchical list in the system. The follow-up design module 115 designs different visit stages and stage time templates of the testees in the actual visit process, field range control setting is carried out on visit data, and the system carries out visit reminding on each tester according to the field range control.
Furthermore, the logically checked data variables comprise single variables and combined variables, the logically checked module further comprises a data questioning module, the data questioning module is used for questioning the automatically logically checked data variables, and the data questioning module comprises input questioning, missing questioning, abnormal value questioning, out-of-window questioning, data out-of-range questioning and manual questioning. The system has various question modes, including generating question in the data input process of a central user, generating question in blank condition of input, generating question in data variable different from a fixed range or a fixed value, generating question in an access super window, generating question in value exceeding a data set range, and simultaneously, being capable of carrying out question in single data variable or a plurality of variable combinations, as follows:
example 1: single data variable challenge
Subject height (cm) field range: 210 or 80
Logic algorithm: if (height >210| < = 80)
Checking results: height beyond range (Normal: 81-210 cm)
Example 2: multiple data variable combination challenge
The content of the question is: height (cm) 80And sex male
Logic algorithm: if (height <81& & sex = 'male')
And (4) checking a result: error height range (Male normal height 81-210 cm)
In the clinical trial electronic data management system 100 provided by the present application, the completion level includes the completion rate of enrollment, the progress of enrollment of the trial center subject, the completion rate of follow-up visits, the completion rate of challenge, adverse events and the statistics of serious adverse events. In the system, the test data are analyzed, the test project completion degree is checked, and the test project progress is controlled in real time.
In the clinical trial electronic data management system provided herein, the randomized screening cohort includes simple randomization, block randomization, hierarchical randomization, and dynamic randomization.
Simple randomization: the probability that the testees are allocated to each test item treatment group is the same, namely the probability of the event A is P (A), and the probability 0 is more than or equal to P (A) and less than or equal to 1, so that the method can be completed through a computer language and is independently allocated to each tester.
The algorithm is as follows: by configuring the sample number samplesize =140, the system automatically performs sampling test and control of P (a) P (B) 1:1 or 2:1 in proportion.
Block randomization: i.e., a randomization process that allocates samples to each granule, where the granule lengths may be the same or different.
The algorithm is as follows:
1) By configuring the samplesamplesize =140 (denoted by s), block = granule block (denoted by b), width = width (denoted by w), and randomly sampled groups are grouped by block sample. Such as: probability:
the problem of intra-group distribution unevenness can be pre-judged in advance by configuring the final intra-group probability 1:1;
2) According to project conditions, under the condition that researchers or related personnel keep blind states, the system can adopt the same project to set the lengths of a plurality of blocks so as to achieve less predictability;
3) To prevent the occurrence of excessive fragmentation groups, the configuration of fixed-entry or contention-entry forms may be implemented by computational logic.
Layering and random: if the therapeutic effect of the drug is affected by some baseline characteristics, the layering may be performed first according to the characteristics, then the randomization may be performed in the layers to ensure intra-layer group balance, or the blocks may be randomly assigned on a layered basis.
The algorithm is as follows: by configuring samplesize =140 and factor = factor, we identify the layering factor and compute the completion P (a) P (B) layering randomness by the system.
Dynamic random: i.e., adaptive randomness, algorithms must be implemented in a computer logic language rather than fixed allocation lists.
The algorithm is as follows: and (3) calculating the adaptive adjustment probability of the sample size and the random event, and automatically controlling and adjusting the value of P by the probability P (A) through a calculation algorithm to finish probability randomization. Taking the minimization algorithm as an example: random probability as sample size s =140
With the reduction of the sample size, P (A) is gradually increased, the interval value is configured in advance, the probability value is automatically calculated and adjusted, the probability is automatically returned to be normal according to groups, and balance can be achieved through stage adjustment.
In the clinical trial electronic data management system 100 provided herein, the subjects module 112 includes screening into groups, viewing case report sheets, printing case report sheets, collecting case report sheets, exporting follow-up records, bad event records, and trace tracing. In the process of operating the system by a central user, the system records and modifies each data variable and the data variable to leave traces, the trace data is stored in a Mysql database by adopting a data independent separation technology, and a data view is created and read for a data table with large traces, so that the trace can be traced for any data variable modification in the system.
As shown in fig. 2, an embodiment of the present application provides a clinical test electronic data management method, which is implemented by a clinical test electronic data management system provided in an embodiment of the present application, and includes:
201. and generating a test scheme according to the test item information and the test center information.
The clinical test electronic data management method can be used for simultaneously managing a plurality of test items, different test items correspond to different test centers, and different test schemes are specified according to conditions of different test centers and requirements of different test items.
202. Collecting and storing the information of the testees, and randomly grouping the testees.
In the specific implementation process, the subjects need to be screened into groups through screening, the subjects are randomly grouped according to a test scheme, the random grouping information can select a proper grouping mode according to the test requirement, and the random screening into the groups comprises simple random, block random, layered random and dynamic random.
203. And designing a case report table for the grouped subjects, wherein the case report table is used for recording follow-up records of the subjects.
In the specific implementation process, different visiting stages and stage time templates of the testees in the actual visiting process are designed, field range control setting is carried out on visiting data, and the system carries out visiting reminding on each tester according to field range control.
204. And checking and controlling the progress of the test project at any time according to the case report table.
In the test process, the test item completion degree is analyzed by analyzing the test data in the case report table, and the test item completion degree can be embodied by the group entry completion rate, the group entry progress of test center testees, the follow-up visit completion rate, the question completion rate, adverse events, the statistics of serious adverse events and the like.
In the clinical trial electronic data management method provided by the application, a case report table is designed for grouped subjects, and the case report table is used for recording follow-up records of the subjects, and comprises the following steps: and (4) establishing a follow-up model for the testee according to the test scheme, and designing a case report table according to the follow-up model.
In the test process, because the test scheme is set for different test items, different test schemes have different administration schemes, different test periods and the like for the testees, different follow-up models need to be formulated according to the conditions of the test periods and the like, and then a case report table is designed for each tester according to the follow-up models.
In the clinical trial electronic data management method provided by the present application, after designing a case report form according to a follow-up model, the method further includes: collecting follow-up data in the case report table, and checking, printing and/or exporting the case report table.
In the method, the case report table can be viewed, printed and/or exported in real time, and the printed case report table can restore 99.9 percent of the paper case report table by typesetting in advance.
In the clinical trial electronic data management method provided by the application, the collecting of follow-up data in a case report table further comprises: and recording adverse events in the follow-up visit process, carrying out logic check on follow-up visit data and generating a question, and tracing the trace of the whole follow-up visit period.
In the specific implementation process, the method automatically checks the data variable, and generates a question for the data variable subjected to automatic logic checking, wherein the data question comprises an input question, a deletion question, an abnormal value question, a super-window question, a data out-of-range question and an artificial question, namely, the question is generated in the data input process of a central user, the question is generated for the blank input condition, the question is generated for the data variable different from a fixed range or a fixed value, the question is generated for the visit super-window, the question is generated for the value exceeding the data setting range, and meanwhile, the question can be generated for a single data variable or a combination of a plurality of variables. In the process of managing clinical test data by a central user, each data variable and the recording and modifying operation trace of the data variable are marked, trace marking data are stored in a Mysql database by adopting a data independent separation technology, and a data view is created and read for a data table with large traces, so that the source tracing of any data variable modification can be realized.
In a third aspect, the present invention provides a computer-readable storage medium, on which a computer program is stored, which, when the computer program runs on a computer, causes the computer to execute a clinical trial electronic data management method provided by an embodiment of the present application.
All the above technical solutions can be combined arbitrarily to form the optional embodiments of the present application, and are not described herein again.
The meaning of the noun is the same as that in the above data forwarding method, and specific implementation details may refer to the description in the method embodiment.
It will be understood by those skilled in the art that all or part of the steps of the methods of the above embodiments may be performed by instructions or by associated hardware controlled by the instructions, which may be stored in a computer readable storage medium and loaded and executed by a processor.
To this end, embodiments of the present application provide a computer-readable storage medium having stored therein a plurality of instructions that can be loaded by a processor to perform the steps of any one of the clinical trial electronic data management methods provided by embodiments of the present application. For example, the instructions may perform the steps of:
generating a test scheme according to the test item information and the test center information; collecting and storing subject information, and randomly grouping the subjects; designing a case report table for grouped subjects, wherein the case report table is used for recording follow-up records of the subjects; and checking and controlling the progress of the test project at any time according to the case report table.
The above operations can be implemented in the foregoing embodiments, and are not described in detail herein.
Wherein the computer-readable storage medium may include: read Only Memory (ROM), random Access Memory (RAM), magnetic or optical disks, and the like.
Since the instructions stored in the computer-readable storage medium can execute the steps in any clinical trial electronic data management method provided in the embodiment of the present application, the beneficial effects that can be achieved by any clinical trial electronic data management method provided in the embodiment of the present application can be achieved, and detailed description is omitted here for the sake of detail in the foregoing embodiments.
The clinical trial electronic data management system and the clinical trial electronic data management method provided by the embodiment of the application are described in detail, specific examples are applied in the description to explain the principle and the implementation of the application, and the description of the embodiment is only used for helping to understand the method and the core idea of the application; meanwhile, for those skilled in the art, according to the idea of the present application, the specific implementation manner and the application scope may be changed, and in summary, the content of the present specification should not be construed as a limitation to the present application.
Claims (10)
1. A clinical trial electronic data management system incorporating a central stochastic system, comprising a data layer and an application layer connected to each other, the data layer storing clinical trial data, the application layer comprising:
the project management module is used for managing different test projects, test centers related to the test projects, central users of the test centers and authorities of the central users;
the test center is used for screening the test subjects, randomly sampling the test subjects through an electronic envelope by combining the central random system, and marking all operations of the test subjects by the central user;
the logic checking module is used for setting a checking rule, automatically and logically checking all data variables input by the central user through a logic algorithm and proposing a logic question;
a central randomization module for performing a stochastic screening of the subjects of the trial project into groups;
the follow-up visit design module is used for automatically crawling and processing the data in the data layer so as to remind each subject of visit;
the research management module is used for checking the completion degree of the test project by analyzing the test data;
wherein the project management module, the subject module, the logic check module, the central randomization module, the follow-up design module, and the study management module are interconnected.
2. The clinical trial electronic data management system of claim 1, wherein the logically-verified data variables include single variables and combined variables, the logically-verifying module further comprising a data-questioning module that generates a question for the automatically logically-verified data variables, the data-questioning module including entry of a question, a missing question, an outlier question, a super-window question, a data-out-of-range question, and a manual question.
3. The clinical trial electronic data management system of claim 1, wherein the completion includes a completion rate for enrollment, a progress of enrollment of the trial center subjects, a completion rate for follow-up visits, a completion rate for challenge, adverse events, and severe adverse event statistics.
4. The clinical trial electronic data management system of claim 1, wherein the randomized screening into groups includes simple randomization, block randomization, hierarchical randomization, and dynamic randomization.
5. The clinical trial electronic data management system of claim 1, wherein the subject module includes screening into groups, viewing case report sheets, printing case report sheets, collecting case report sheets, exporting follow-up records, bad event records, and trace back.
6. A clinical test electronic data management method implemented by the clinical test electronic data management system according to any one of claims 1 to 5, comprising:
generating a test scheme according to the test item information and the test center information;
collecting and storing subject information, and randomly grouping the subjects;
designing a case report table for the grouped subjects, wherein the case report table is used for recording follow-up visit records of the subjects;
and viewing and controlling the progress of the test project at any time according to the case report table.
7. The clinical trial electronic data management method of claim 6, wherein the designing a case report form for the grouped subjects, the case report form for recording the subject follow-up records, comprises:
formulating a follow-up model for the subject according to the test protocol;
and designing the case report table according to the follow-up model.
8. The clinical trial electronic data management method of claim 7, further comprising, after designing the case report form according to the follow-up model:
collecting follow-up data in the case report table;
viewing, printing, and/or exporting the case report form.
9. The clinical trial electronic data management method of claim 8, wherein the collecting follow-up data in the case report form further comprises:
recording adverse events in the follow-up process;
carrying out logic check on the follow-up visit data and generating a question;
trace tracing is carried out on the whole follow-up visit period.
10. A computer-readable storage medium on which a computer program is stored, the program being executed by a processor to implement the clinical trial electronic data management method according to any one of claims 6 to 9.
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