Drug Evaluation Committee 2008-34 Change of Case Report Form to EDC
Related classification: Other
Initial release date: Mar. 2009
Revised publication date: Apr. 2013
Question
Article 10 of GCP (Prior submission of documents to the head of the implementing medical institution) stipulates the submission of "(3) Sample of case report form".
A sample was submitted at the time of new application, and at that time, it was a paper CRF. I was informed that the system has since been changed to Electronic Data Capture System (EDC), but the contents of the CRF itself remain unchanged.
I think the reason why Article 10 of the GCP requires the submission of a "sample case report form" is to confirm the contents of the report, but in the case of a change from paper to EDC (or vice versa), is it correct to think that there is no need to report the change to the IRB? I think it is not necessary to specify whether the "sample case report form" is in paper form or EDC when submitting a new application.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the case of your question, not only will the reporting method be changed from paper to electronic, but also the clinical trial implementation system including the site side, such as the input of clinical data and electronic signatures into eCRF by investigators and CRCs, the loading of clinical laboratory values from the central clinical laboratories to the sponsor, and the direct viewing method by monitors will also be changed. Therefore, it is expected that the description of the description and submission of CRF in the clinical trial protocol will be changed.
Therefore, it is expected that the description regarding the description and submission of the CRF in the clinical trial protocol will be changed.
-
As of December 2023In Article 10, Paragraph 1, Guidance 1 of the GCP, it is stated that "If the protocol for the clinical trial contains sufficient information that can be read in the case report form, the protocol for the clinical trial may be interpreted as including information on the sample of the case report form. Therefore, a sample case report form is not required as a document to be submitted to the head of the investigational site.
Reason for revision of opinion
The quoted part from the former GCP operation notice (October 1, 2008, Pharmaceutical Affairs Bureau of Japan, No. 1001001) has been deleted.