CN114496129A - A method for clinical trial execution - Google Patents

Abstract

The invention relates to the technical field of clinical trials, and discloses a method for executing clinical trials, comprising a preliminary preparation terminal, a mid-term test terminal, a later-stage finishing terminal, and a server; the preliminary-stage preparation terminal is connected to the intermediate-stage testing terminal and the later-stage sorting terminal through the server; The test terminal is connected to the post-processing terminal through the server; the preliminary preparation terminal: used for the preliminary preparation of the test work and the arrangement of facilities such as wards; the mid-term test terminal: used to monitor the overall process of the test process and record the test situation; Post-arrangement terminal: used to organize and store test data. The clinical trial execution platform and method can standardize the test process through the execution platform, make clinical trials streamlined, standardized and electronic, number the testers, facilitate the online integration of testers' information, and facilitate the testing of testers. File information management to avoid the loss of its file information.

Description

A method for clinical trial execution

technical field

The invention relates to the technical field of clinical trials, in particular to a method for executing clinical trials.

Background technique

The clinical research execution platform refers to the management process of the clinical trial, the baseline data of the subjects recorded during the trial, including the demographic data, the baseline data checked at the time of enrollment, the implementation of the trial process, and the result data. All contents of the medical record table are recorded online based on the Internet and transmitted to the central database for preservation and management.

There are many roles in the clinical trial process of drugs, such as investigators, clinical monitors and clinical trial coordinators. At present, when managing clinical trials, offline management methods are often used, which often require many The characters are connected offline, which leads to the difficulty of file management and the confusion of connection.

SUMMARY OF THE INVENTION

(1) Technical problems solved

The present invention provides a method for clinical trial execution, which has the advantages of convenient connection of various departments and the like, and solves the problems raised by the background technology.

(2) Technical solutions

The present invention provides the following technical solutions: a method for executing a clinical trial, comprising a preliminary preparation terminal, a mid-term test terminal, a later-stage finishing terminal, and a server; the preliminary-stage preparation terminal is connected to the intermediate-stage testing terminal and the later-stage finishing terminal through a server; The test terminal is connected to the post-processing terminal through the server;

The pre-preparation terminal: used for pre-preparation of the test work, arrangement of facilities such as wards;

The mid-term test terminal: used to monitor the overall process during the test and record the test situation;

The post-arrangement terminal: used to organize and store the test data.

Preferably, the preliminary preparation end includes the establishment of the test project, the recruitment of test personnel, the screening of test personnel, and the preliminary preparation of test equipment;

Project establishment of the test project: submit and approve the test project, carry out the project establishment preparation test, and the project is one or more;

Recruitment of test personnel: After the project is established, drug test personnel are recruited and online registration is carried out;

The screening of test personnel: the basic information is uploaded by the test personnel, based on the comparison of big data, the applicants are screened, and the screening personnel are classified according to the project, and the number is generated to generate a two-dimensional code, and the mobile terminal scans it;

The preliminary preparation of the test equipment: used for the preparation of materials such as medical equipment, and the arrangement of the ward and the test personnel.

Preferably, the mid-term test terminal includes test medication, observation during the test period, and recording and feedback during the test;

The test drug: used to check the drug used in the test, and to classify different drugs;

Observation in the test time period: used to observe the drug reaction after drug administration to the test personnel;

Recording and feedback in the test process: used to record the test data of the medication process and the reaction, and provide feedback to the administrator when necessary.

Preferably, the post-arrangement terminal includes test data collection and import, test data classification and integration, test personnel case table generation, test data verification, and test data comparison;

The test data collection and import: used to collect the data generated in the test process, and upload the collected test data;

The test data classification integration: used to integrate the data collected in different time periods of the same project, and to classify, integrate and store the data of different projects;

The test personnel case table generation: after the test is completed, the test personnel cases are automatically generated into a book;

The test data check: used to compare the test data again;

The test data comparison: input ideal data, which is used to automatically compare the test data of the test personnel with the ideal data, automatically count the proportion of qualified personnel and unqualified personnel, and determine whether the drug test is passed.

Preferably, the recruitment is an Internet platform, advertising promotion, leaflet distribution, and the like.

Preferably, the mobile handheld terminal is a two-dimensional code scanner.

A method for clinical trial execution, comprising the following steps:

Step 1: Carry out the preliminary preparation for the test, first apply for the project approval of the test project;

Step 2: After the project is approved and approved, the test personnel are recruited and screened, and the test personnel are numbered and registered;

Step 3: After arranging the personnel, prepare the medicines and medical devices required in the test process;

Step 4: administer medication to the test personnel, observe the reaction of the medication personnel within the time period, and collect test data;

Step 5: After the test data collection is completed, upload and integrate the test data;

Step 6: Integrate the data and other test records generated by the test personnel into a book for storage, and use it for reference and inspection by other personnel.

(3) Beneficial effects

The present invention has the following beneficial effects:

1. This kind of platform and method for clinical trial execution can standardize the test process through the execution platform, make clinical trials streamlined, standardized and electronic, number the test personnel, and facilitate the online integration of the information of the test personnel. The tester's file information is managed to avoid the loss of their file information.

2. This kind of platform and method for clinical trial execution, through the execution platform, can coordinate the communication between various departments during the trial, so that during the clinical trial, different roles can timely understand the trial process according to the platform, and know the trial process at any time. In order to achieve standardized management.

Description of drawings

Figure 1 is a schematic structural diagram of the present invention.

Detailed ways

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Please refer to Figure 1, a platform for clinical trial execution, including pre-preparation, mid-trial, post-processing, and server; the pre-preparation terminal is connected to the mid-trial and post-processing terminals through the server; the mid-trial terminal is connected to the late-stage through the server finishing end;

Preliminary preparation end: used for the preliminary preparation of the test work and the arrangement of facilities such as wards;

Mid-term test terminal: used to monitor the overall process during the test and record the test situation;

Post-arrangement terminal: used to organize and store test data.

Further, the preliminary preparation side includes the establishment of the test project, the recruitment of test personnel, the selection of test personnel, and the preliminary preparation of test equipment;

Test project approval: submit and approve the test project, prepare the test for project approval, and the project is one or more;

Recruitment of test personnel: After the project is established, drug test personnel will be recruited, and online registration will be carried out to recruit for Internet platforms, advertising promotion, leaflet distribution, etc.;

Screening of test personnel: The test personnel upload basic information, and based on the comparison of big data, the applicants are screened, and the screeners are classified according to the project, and the number is generated to generate a two-dimensional code, and the mobile handheld terminal is used as a two-dimensional code scanner;

Preliminary preparation of test equipment: used to prepare medical equipment and other materials, and arrange wards and test personnel.

Further, the mid-term trial end includes trial medication, observation during the trial period, and recording and feedback during the trial;

Trial drugs: used to check the drugs used in the test, and to classify different drugs;

Observation during the test period: it is used to observe the drug reaction after the drug is administered to the test personnel;

Recording and feedback during the trial process: It is used to record the trial data and the response of the medication process, and provide feedback to the manager when necessary.

Further, the post-processing end includes the collection and import of test data, the classification and integration of test data, the generation of test personnel's case table, the verification of test data, and the comparison of test data;

Test data collection and import: used to collect the data generated during the test, and upload the collected test data;

Classification and integration of test data: It is used to integrate the data collected in different time periods of the same project, and classify, integrate and store the data of different projects;

Experimenter's case table generation: After the experiment is completed, the experimenter's case will be automatically generated into a book;

Test data verification: used to compare the test data again, to ensure the accuracy of the test data, and to avoid the omission or input error of the test data;

Test data comparison: input ideal data to automatically compare the test data and ideal data of the test personnel, automatically count the proportion of qualified personnel and unqualified personnel, and determine whether the drug test has passed.

A method for clinical trial execution, comprising the following steps:

Step 1: Carry out the preliminary preparation for the test, first apply for the project approval of the test project;

Step 2: After the project is approved and approved, the test personnel are recruited and screened, and the test personnel are numbered and registered;

Step 3: After arranging the personnel, prepare the medicines and medical devices required in the test process;

Step 4: administer medication to the test personnel, observe the reaction of the medication personnel within the time period, and collect test data;

Step 5: After the test data collection is completed, upload and integrate the test data;

Step 6: Integrate the data and other test records generated by the test personnel into a book for storage, and use it for reference and inspection by other personnel.

The clinical trial execution method of the present invention makes the clinical trial process standardized, standardized and electronic, numbers the test personnel, facilitates the online integration of the information of the test personnel, and can strictly control the entire process in the test process. , so as to effectively avoid unexpected problems during the test and protect the safety of the test personnel.

Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, and substitutions can be made in these embodiments without departing from the principle and spirit of the invention and modifications, the scope of the present invention is defined by the appended claims and their equivalents.

Claims (7)

1. A platform for executing clinical tests is characterized by comprising an early preparation end, a middle test end, a later finishing end and a server; the early preparation end is connected with the middle test end and the later finishing end through a server; the middle-stage test end is connected with the later-stage finishing end through a server;

the early preparation end: the device is used for the early preparation of test work, arrangement of using facilities such as wards and the like;

the middle test end: the system is used for monitoring the whole flow in the test process and recording the test condition;

and the later-stage finishing end: the device is used for sorting and storing the test data.

2. The platform of claim 1, wherein: the early preparation end comprises test project establishment, test personnel recruitment, test personnel screening and early preparation of test instruments;

the test project is established as follows: submitting and approving test items, and performing a standing preparation test, wherein the items are one or more;

recruitment of the panelists: after the project is established, the drug administration testers are recruited and reported on the internet;

screening by the tester: basic information is uploaded by a tester, screening is carried out on registration personnel based on big data comparison, screening personnel are classified according to projects, numbering is carried out on the screening personnel to generate a two-dimensional code, and the mobile terminal scans the two-dimensional code;

preparing the test apparatus at an early stage: the device is used for preparing materials such as medical instruments and the like, and arranging wards and testers.

3. The platform of claim 1, wherein: the middle-term test end comprises test medication, test time period observation, and recording and feedback in the test process;

the test drugs are as follows: the system is used for checking the use of medicines during the test and classifying different medicines;

observation of the test period: the device is used for observing the drug reaction after the drug is applied to a tester;

recording and feeding back in the test process: the system is used for recording the test data of the medication process and the generated response and feeding back to the manager when needed.

4. The platform of claim 1, wherein: the later-stage finishing end comprises test data acquisition and import, test data classification and integration, test personnel case table generation, test data verification and test data comparison;

collecting and importing the test data: the device is used for collecting data generated in the test process and uploading the collected test data;

and (3) classifying and integrating the test data: the system is used for integrating data collected in different time periods of the same project and classifying, integrating and storing different project data;

and generating a disease case table of the test person: after the experiment is finished, the case of the experimenter automatically generates a book;

and (3) checking the test data: for re-comparing the test data;

comparison of the test data: and inputting ideal data for automatically comparing the test data of the tester with the ideal data, automatically counting the proportion of qualified personnel and unqualified personnel, and determining whether the drug test passes or not.

5. A platform for clinical trial execution according to claim 2, wherein: the recruitment includes an internet platform, advertisement promotion, leaflet issuing and the like.

6. A platform for clinical trial execution according to claim 2, wherein: the mobile handheld terminal is a two-dimensional code scanner.

7. A method for clinical trial execution, characterized by: the method comprises the following steps:

the method comprises the following steps: carrying out preliminary preparation of a test, firstly, applying for project establishment on a test project;

step two: after the items are passed and established, recruiting and screening testers, and numbering and registering the testers;

step three: after arranging the personnel, preparing the medicines and medical instruments needed in the test process;

step four: the method comprises the following steps of (1) applying medicine to a tester, observing the reaction of the person applying the medicine within a time period, and collecting test data;

step five: after the test data are collected, uploading the test data and integrating the test data;

step six: test records such as data generated by a tester are integrated into a book for storage, and the book is used for reference and inspection by other personnel.

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