Drug Evaluation Committee 2017-07 Records of Deviations from the Clinical Trial Protocol (Part 2)
Related classification: Deviation
Date of first publication: June 2017
Question
I have a question about how to keep a record of the facility's "Record of Deviations." If a deviation is noted in the follow-up letter sent by the monitor, can the retention of the follow-up letter be a facility record of the deviation? If the follow-up letter is signed by the investigator, is it a record? Or is it considered a record as long as the letter is preserved? Depending on the study, the investigator's signature on the list of deviations listed by EDC may be required as a deviation record.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The investigator or sub-investigator is required to record all deviations from the study protocol, regardless of the reason (GCP Article 46 Guidance 2). This must be done in a timely manner in accordance with the progress of the clinical trial and the occurrence of deviations, and is recorded in documents prepared at the site, such as source documents.
On the other hand, the follow-up letter prepared by the monitor is provided to the investigator as a record of matters confirmed and discussed during monitoring, and is a document prepared after monitoring. Therefore, even if the investigator signs the follow-up letter, it is not appropriate to use the follow-up letter as a record of deviations from the study protocol. It is important to first ensure that the fact of deviation can be confirmed from the records prepared by the site.
Please also refer to our previous opinion ( 2016-35 ) on how to prepare records of deviations.