Guidance for eMail Communications

The TMF Reference model provides guidance for the management of e-mail communications in clinical studies. Here's a summary of the key points:

1. Use a standardized email account: Use a standardized email account that is monitored by multiple individuals who are trained in the handling of emails related to clinical studies.

2. Develop clear email policies: Develop clear policies for the use of email in clinical studies, including guidelines for email content, attachments, and response times.

3. Train staff on email communication: Train study staff on the proper use of email communication, including how to ensure that emails are secure, confidential, and compliant with applicable regulations.

4. Keep records of email communication: Keep records of all email communications related to clinical studies, including the sender, recipient, date and time of the email, and the content of the email.

5. Monitor email traffic: Monitor email traffic to ensure that all communications related to clinical studies are properly handled and that any issues are addressed promptly.

6. Establish a system for managing email communication: Establish a system for managing email communication related to clinical studies, including protocols for reviewing, responding to, and archiving emails.

7. Ensure compliance with applicable regulations: Ensure that all email communication related to clinical studies complies with applicable regulations, such as HIPAA, GDPR, and 21 CFR Part 11.

By following these guidelines, clinical study teams can effectively manage email communication related to their studies while maintaining compliance with applicable regulations.