Drug Evaluation Committee 2013-07 Necessity of preservation of e-mails between investigators and sponsors
Related classification: Record keeping
First published: Jul 2013
Revised publication date: Apr 2024
Question
In Article 41, Paragraph 1, Guidance 2 of GCP, it is stated that "Documents or records related to the conduct of the clinical trial that the investigator preserves in accordance with the instructions of the head of the site include those related to letters, meetings, telephone communications, etc. with the sponsor regarding important matters related to the conduct of the clinical trial.
At our hospital, the sponsor delivers the safety information to the investigator by e-mail or mail, and the investigator replies to the sponsor by e-mail with "whether or not to continue the trial," "whether or not to revise the study protocol," and "whether or not to revise the consent document. Currently, safety information is stored in paper form that is mailed to us. The investigator's opinion is stated in the "Application for Changes Related to Clinical Trials," so we save that. In this case, is it still necessary to save the e-mail as the first record of the first occurrence?
The Pharmaceutical Manufacturers Association's view
The investigator's final opinion on the safety information will be included in the "Application for Change Regarding Clinical Trial. On the other hand, e-mails between the investigator and the sponsor are preliminary records of communications between the parties that occur in the process of preparing the relevant documents.
Therefore, if the "Application for Change of Clinical Trial" is preserved and the agreement between the two parties on the safety information can be confirmed, it is not necessarily necessary to preserve the e-mail. On the other hand, if the seal is omitted from the "Application for Change of Clinical Trial Information," it is necessary to preserve evidence that the document was properly prepared and not altered, and preservation of the e-mail may be necessary as a way to do so.