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Clinical research time schedule generation method and system, and equipment

A technology for generating systems and time, applied in electronic clinical trials, medical care resources or facilities, instruments, etc., can solve problems such as inability to determine clinical tasks and scheduling, and consumption of CRC work energy.

Pending Publication Date: 2021-04-27
北京新研汇医药研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, CRC needs to complete a large number of clinical tasks, and needs to track or visit the subjects throughout the clinical research cycle, so the timetable or schedule of each task is a necessary condition to ensure the successful completion of clinical research, and it also consumes This problem is more prominent when there are a large number of subjects in the group
In addition, due to the characteristics of drug clinical research, at the beginning of the clinical project, it is impossible to determine the accurate clinical tasks and schedule, such as the number of treatment cycles for different subjects may be different, the withdrawal situation that may occur in clinical research, and the treatment cycle In the long-term follow-up after the end, these clinical events cannot accurately determine the start and end time when planning, which brings further challenges to the formulation of clinical research timetable

Method used

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  • Clinical research time schedule generation method and system, and equipment
  • Clinical research time schedule generation method and system, and equipment
  • Clinical research time schedule generation method and system, and equipment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] Specifically, as figure 1 As shown, the present invention provides a method for generating a clinical research schedule, comprising the following steps:

[0122] S101, receiving clinical stage information of clinical research;

[0123] In the specific implementation process, the clinical stage information includes various stages of the clinical research project, including but not limited to: screening period, treatment period, unplanned visit, post-treatment visit (EOT visit), safety follow-up , long-term follow-up, etc. During the above clinical stage, the clinical coordinator (CRC) needs to collect information from the patient to realize the record of the patient's clinical situation. The content of the information collection includes, but is not limited to, informed consent, medical history collection, physical examination, physical examination, blood urine and stool examination, and the like.

[0124] As an optional embodiment, after receiving the clinical stage ...

Embodiment 2

[0150] like figure 2 As shown, the present invention also provides a method for generating a clinical research time plan, comprising the following steps:

[0151] S201, receiving clinical task information to be completed;

[0152] In the specific implementation process, the creator of the clinical research time plan enters the clinical task information to be completed. In some embodiments, the clinical tasks to be completed include informed consent, qualification standard confirmation, medical history investigation, smoking status investigation, Physical examination, questionnaire filling, weight examination, height examination, electrocardiogram examination, hematology examination, biochemical examination, urinalysis, etc. The above tasks to be completed are clinical tasks that need to be completed one or more times in different stages of clinical research.

[0153] S204, generating a clinical research schedule according to the above method;

[0154] In the specific implemen...

Embodiment 3

[0170] like image 3 As shown, the present invention also provides a progress recording method for a clinical research project, comprising the following steps:

[0171] S301, generating a clinical research time plan according to the above method;

[0172] During the specific implementation, any method as described in Example 2 was used to generate the clinical study time plan.

[0173] S302, match the clinical research time plan with the staff;

[0174] In the specific implementation process, the clinical research time plan generated in S301 is matched with the corresponding personnel in the system, and the staff member can obtain the corresponding clinical research time plan through a terminal device such as a mobile phone by means of account login, etc. The above acquisition method can be realized through a small program or APP of the mobile terminal. The above staff can be CRC.

[0175] S303, receiving a patient input instruction;

[0176] In the specific implementatio...

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Abstract

The invention provides a clinical research schedule generation method. The clinical research schedule generation method comprises the following steps: receiving clinical stage information of clinical research; receiving an information acquisition time formula of each clinical stage; and generating a clinical research schedule according to the information acquisition time formula of each clinical stage. In addition, the invention also provides equipment and a system capable of realizing the method. According to the clinical research schedule generation method, equipment and system provided by the invention, the clinical research task schedule can be automatically generated, and the working efficiency of CRC can be significantly improved.

Description

Technical field: [0001] The invention relates to the field of drug clinical research implementation, and in particular, to a method, device and system for generating a clinical research time schedule. Background technique: [0002] With the rapid development of the new drug research and development industry in recent years, the demand for clinical research of drugs by Chinese pharmaceutical companies has increased significantly. However, clinical research has the characteristics of long research period and high cost of recruiting subjects. It is necessary for the staff involved in clinical research to have a strong sense of professionalism and responsibility to ensure the smooth progress of clinical research. [0003] In clinical research, the groundwork is mainly done by the clinical coordinator (CRC). Therefore, CRC needs to complete a variety of clinical tasks, and subjects need to be tracked or visited throughout the clinical research cycle. Therefore, the timetable or ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H10/20G16H40/20G06Q10/10
CPCG16H10/20G16H40/20G06Q10/1093
Inventor 叶纪平阎昭徐文王雨萌
Owner 北京新研汇医药研发有限公司
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