Drug Evaluation Committee 2013-65 Record of Responsible Clinical Investigator's Review of Clinical Trial Agreement
Related classification: clinical trial contracting procedures
Date of first publication: Apr. 2014
Question
The investigator's signature is no longer required on the clinical trial agreement, 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 recorded in the monitoring report.
Opinion of the Pharmaceutical Manufacturers Association of Japan
"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.