Drug Evaluation Committee 2016-32 Addition of required data items for case report forms
Related classification: Clinical Trial Review Committee
Date of first publication: October 2016
Question
If the items to be included in the case report form were sufficiently legible in the clinical trial protocol, a sample of the case report form was no longer required as a document to be submitted to the Investigator Site Chairperson, so no sample was submitted for review by the initial Clinical Trial Review Committee. The sponsor suddenly requested us to fill in the EDC page since it was added to the EDC page. Therefore, the addition of the new form was not approved by the review committee and was not notified to the CRC in advance. When we inquired about the fact that the addition of the additional form had not been reviewed, we were told that "the study protocol states that 'a supplemental case report may be required for adverse events and abnormal laboratory values reported or confirmed during the study period', and therefore, a review by the study review committee is necessary. The response was, "Since the clinical trial protocol states that 'a supplemental case report may be required for adverse events and laboratory abnormalities reported or confirmed during the clinical trial period,' review by the investigational review committee is not necessary.
Is the additional pages in the EDC not part of the review process?
JPMA's Opinion
As you mentioned in your question, if the items to be included in the case report can be adequately read from the study protocol, there is no need to submit a sample of the case report at the time of the request for clinical trial (GCP Article 10, Paragraph 1, Guidance 1 (3)).
As in this case, there are cases in which additional data provided by the Investigator Site may be required for the evaluation of the efficacy or safety of the investigational drug by the sponsor. In such cases, it is necessary to determine not whether there are additional pages in the case report form, but whether the additional data required can be read from the study protocol as items to be included in the case report form. If the additional data can be adequately read from the study protocol, review by the Clinical Trial Review Committee is considered unnecessary.