Drug Evaluation Committee 2015-06 Materials and Information Required for Preparation of Explanatory Documents
Related classification: Obtaining consent
Date of first publication: August 2015
Question
Does the "materials and information necessary for the person who is to be the investigator to prepare the (subject's) explanatory document" described in GCP Article 9 Guidance 1 refer to the draft explanatory document? Also, if the sponsor provides a draft explanatory document, is there an obligation to preserve it?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The necessary materials and information described in GCP Article 9 Guidance 1 are not limited to the draft explanatory document, but also include all items necessary for the investigator to consider and prepare the items to be explained to the subject as stipulated in GCP Article 51, such as the study protocol, investigational new drug summary, and additional safety information.
Regarding what materials and information were provided by the sponsor to the investigator, "Documents or Records Related to Clinical Trials" (MHLW, Pharmaceutical and Food Safety Bureau, Review and Management Division, February 14, 2013, Office Communication) states that "records of materials provided necessary for preparation of consent documents and other documents" (records of materials provided by the sponsor to the investigator for preparation of consent documents and (a record indicating that the sponsor provided the investigator with the materials necessary to prepare the consent document and other explanatory documents).
Therefore, it is not necessarily necessary for the site to retain the draft explanatory document provided by the sponsor, but it is desirable for the site to retain it as a record related to the preparation and revision of the explanatory document.