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Original file mapping and management method applied to clinical trial data, and system thereof

A data management system and original file technology, applied in the field of clinical trial data collection, can solve the problem of not taking a lot of time to find, affecting the progress of clinical trials, etc., to achieve the effect of ensuring progress

Active Publication Date: 2019-01-04
北京遥领医疗科技有限公司
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Problems solved by technology

At this time, it is necessary to ensure that the case report form CRF transcribed by the research nurse CRC is accurate and that the entry staff enters correctly. Due to the long time of the clinical trial, if there is a problem with the entered data later, it is necessary to find the original test documents at that time. Check, at this time, it is not only necessary to ensure that the original documents are kept intact and clear, otherwise it will not be found or it will take a lot of time to search, which will greatly affect the progress of clinical trials in terms of data collection and data monitoring

Method used

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  • Original file mapping and management method applied to clinical trial data, and system thereof
  • Original file mapping and management method applied to clinical trial data, and system thereof
  • Original file mapping and management method applied to clinical trial data, and system thereof

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Embodiment Construction

[0088] refer to figure 1 As shown, the present invention is applied to the original file mapping and management methods of clinical trial data, including:

[0089] 101. Obtain structured test data and corresponding original files. The structured test data refers to data in a clear and uniform character format, such as the item code, item name, and corresponding The value of the test result;

[0090] 102. Establish a mapping relationship between the structured test data and the original file, so that the current structured test data corresponds to at least one original file;

[0091] 103. Store the structured test data, original files, and the mapping relationship between the structured test data and original files in the clinical trial data management system;

[0092] 104. Obtain structured test data from the clinical trial data management system;

[0093] 105. Retrieve the corresponding original file according to the mapping relationship between the current structured test...

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Abstract

The invention discloses an original file mapping and management method applied to clinical trial data, and a system thereof. The method is characterized by through establishing a mapping relation between structured test data and an original file, when the structured test data is obtained, retrieving the corresponding original file automatically according to the mapping relation; and when subsequent data is found to have problems or a clinical inspector challenges the data, displaying the corresponding original file automatically. Time used for finding the original file can be greatly saved andthe risk of loss of the original file can be effectively reduced, and the progress of a clinical trial is ensured.

Description

technical field [0001] The invention relates to the field of clinical experiment data collection, in particular to an original file mapping and management method and system applied to clinical experiment data. Background technique [0002] Clinical trials refer to any systematic study of drugs in humans to confirm or reveal the effects of experimental drugs, adverse reactions and / or absorption, distribution, metabolism and excretion of experimental drugs, with the purpose of determining the efficacy and safety of experimental drugs. Clinical trials are an important part of saving time and cost in the research and development of new drugs. In the past, the experimental structure in clinical trials was processed in the following ways. For paper-based clinical trial data, such as laboratory test results, etc., the research nurse (CRC) The work is transcribed into the case report form CRF (the case report form refers to a document designed according to the clinical trial protoco...

Claims

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Application Information

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IPC IPC(8): G16H10/40G16H15/00
CPCG16H10/40G16H15/00
Inventor 张洪亮
Owner 北京遥领医疗科技有限公司
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