CLINICAL TRIAL/CLINICAL STUDY SUPPORT SYSTEM, CLINICAL TRIAL/CLINICAL STUDY SUPPORT METHOD, ELECTRONIC MEDICAL CHART AND EDC COORDINATION SUB-SYSTEM, AUTOMATIC TRANSCRIPTION PROGRAM, AND ELECTRONIC MEDICAL CHART-RECORDING PROGRAM

摘要

PROBLEM TO BE SOLVED: To achieve enhanced efficiency in terms of the number of persons and time even with correctness ensured for a transcription work in a creation of a CRF (Case Report Form) or work of a SDV (Source Data Verification).SOLUTION: A clinical trial/clinical study support system comprises: an electronic medial chart system 10; an EDC (Electronic Data Capture) system 20; and an electronic medical chart and EDC coordination sub-system 30 which makes the electronic medical chart system 10 and the EDC system 20 coordinate. The electronic medical chart and EDC coordination sub-system 30 is configured to store electronic medical chart data output from the electronic medical chart system 10 as a work sheet and construct CRF data from the work sheet to output the CRF data, and the EDC system 20 is configured to input the CRF data output from the electronic medical chart and EDC coordination sub-system 30. Further the electronic medical chart and EDC coordination sub-system 30 is configured to detect a difference between the CRF data stored in the EDC system 20 and the electronic medical chart data.