Drug Evaluation Committee 2013-65 Record of the Investigator's Review of the Clinical Trial Agreement
Related classification: Clinical trial contract procedures
Date of first publication: 04/2014
Question
The investigator's signature confirming the clinical trial agreement is no longer required, but will this be a problem if we do not keep a record of his/her confirmation somewhere? We have an agreement that the investigator must sign a copy of the agreement or, if not, a record of the discussion must be kept in the monitoring report.
JPMA's opinion
"The investigator confirms the contents of the agreement, but does not necessarily need to sign it." (GCP Article 13, Paragraph 1, Guidance 1), but GCP does not stipulate any specific procedure for this confirmation. To ensure that the investigator has confirmed the contents of the agreement, it is recommended that some record be kept, such as a copy of the agreement in the investigator's file.