Drug Evaluation Committee July 2013: The Need to Retain E-mail Correspondence Between Principal Investigators and Sponsors
Related Category: Record Retention
Initial Publication Date: July 2013
Revised Publication Date: April 2024
Question
Guidance 2 for Article 41, Paragraph 1 of the GCP states that “documents or records related to the conduct of a clinical trial that the principal investigator retains in accordance with the instructions of the Investigator Site head include correspondence, meetings, telephone communications, etc., with the sponsor regarding important matters related to the conduct of the clinical trial.”
At our hospital, the sponsor sends safety information to the principal investigator via email or regular mail, and the principal investigator replies via email regarding “whether to continue the clinical trial,” “whether a revision to the clinical trial protocol is necessary,” and “whether a revision to the informed consent document is necessary.”Currently, we retain the paper copies of safety information that are sent to us by mail. Since the principal investigator’s opinion is recorded in the “Application for Changes to the Clinical Trial,” we retain that document. Even in this case, is it necessary to retain the email as the very first record of the event?
JPMA Opinion
The principal investigator’s final opinion regarding safety information is recorded in the “Application for Amendment to the Clinical Trial Protocol.” On the other hand, emails exchanged between the principal investigator and the sponsor are preliminary records of communication between the parties that arise during the process of preparing that document.
Therefore, if the “Application for Amendment to a Clinical Trial” is retained and the terms of agreement between the two parties regarding the safety information can be confirmed, it is not necessarily required to retain the relevant emails.However, if the “Application for Amendment to a Clinical Trial” is submitted without a seal, it may be necessary to retain the relevant emails as evidence that the document was properly prepared and has not been altered.