Drug Evaluation Committee 2021-70 Form 2: Custodian of the original list of investigators and collaborators in a clinical trial
Related classification: Record keeping
Date of first publication: Jul. 2022
Question
We are contacting you to ask for information regarding the custodian of the original list of investigators and collaborators in a clinical trial.
The flow of documents in Form 2_List of investigators and collaborators is as follows,
1) The investigator prepares the list and submits it to the head of the site (the upper part of the form).
(2) The head of the site approves the list and returns it to the principal investigator who submitted it (the lower part of the form).
We have been thinking that the "original" approved by the head of the site should be kept by the "principal investigator".
However, the footer of the Form 2 states, "(Omitted) The head of the site or the investigator shall submit this form to the sponsor. The footer part of Form 2 states, "The head of the site or the investigator shall submit this form to the sponsor.
I have heard that some medical institutions prepare two copies of the original Form 2 and the "investigator" and "sponsor" keep the original for their own use.
Therefore, we would like to ask for your opinion on who keeps the originals.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the attached GCP Guidance No. 1228/7 issued on December 28, 2012, the 11th major revision from the previous Operational Notification states that "For documents that are not required to be signed or stamped with a name and seal, if they contain the stipulated contents, the distinction between original and copy is no longer necessary. (GCP Ministerial Ordinance Article 13, Paragraph 2, Article 32, Article 36)". After this amendment, the "list of investigators and collaborators approved by the head of the site" kept by the site may be either an original or a copy. Therefore, whether the investigator and sponsor both retain the original or one of them should retain the original should be stipulated in the standard operating procedures (SOP) of the medical institution, and the operation should be conducted in accordance with such SOP.