Drug Evaluation Committee 2012-06 The Scope of Required Records of Deviations from the Clinical Trial Protocol (Part 4)
Related classification: Other
First published: Jun. 2012
Question
Please tell us how to keep records of deviations from the clinical trial protocol.
Recently, a screening test was conducted with an extended screening period as a deviation that was not intended to avoid immediate danger to the subject. The site confirmed that the deviation was recorded as a deviation in the GCP compliance section of the clinical trial status report. GCP states that all deviations must be recorded. However, if there is a record in the Investigational Procedure Report, as in this case, is it mandatory to record the deviations in the original documents such as the medical record?
JPMA's Opinion
In accordance with GCP Article 46, Paragraph 1, Guidance 2, the investigator or subinvestigator must record all deviations from the study protocol (hereinafter referred to as "deviations"), regardless of the reason, but there are no regulations regarding where the records should be kept. Therefore, if the deviations are already recorded in the Investigational Procedure Report, there is no need to add the deviations to the medical record.
The Investigational Procedure Report is a document prepared by the investigator for the annual IRB continuing review. On the other hand, the record of deviations is a record of the facts and needs to be prepared in a timely manner, considering the need for prompt discussion between the monitor and the investigator on measures to prevent recurrence of such deviations.
Since the screening period was extended in this case, the timing of such inspection is usually already recorded on the inspection slip or CRF, etc., and such records will reveal that the inspection timing specified in the study protocol was deviated from, so the inspection slip, CRF, etc., should be regarded as the record of the deviation. Therefore, it would be more common to consider the records such as test slips and CRFs as the records of deviations.