Announcing: Guidance for Managing Trial-related Emails

TMF Reference Model “Guidance for the Management of e-Mail Communications in Clinical Studies” v1.0 Published 31-Jul-2020

This “Guidance for the Management of e-Mail Communications in Clinical Studies” is intended to provide recommendations to the life sciences industry on the management of e-mail communications generated throughout the conduct of a clinical study.  Topics covered include:  best practices for managing e-mail, responsibility for the filing of e-mails, handling e-mail attachments, e-mail threads, periodic review, e-mail archiving and preservation, and regulatory expectations and citations.

Please note that this document is intended solely as guidance and is not intended to be prescriptive or to be interpreted as mandated by regulation or legislation. It is based upon the collective experience, knowledge, and best judgment of members of the TMF Reference Model e-Mail Communications Sub-Group as well as direct feedback and approval from the TMF Reference Model Steering Committee.

The recommendations in this guidance should be adapted to reflect the needs of each organisation’s own specific requirements.

The e-mail Communications subgroup started in October 2019 and comprised the following members:

Shah AshrafTransperfect
Mary Ann BrooksBaxter Healthcare Corporation
Kathie ClarkEnnov
Dickson D’souzaIQVIA
Cynthia PintoGSK
Tiffany StewardAstellas
LoriAnn VernaJustInTimeGCP
Jennifer WilsonSyneos Health
Jamie TothDaiichi Sankyo, Inc.
Russell JoyceHeath Barrowcliff Consulting
Mark MercerCGI

If you have feedback on the guidance, please add a question or comment in our online discussion Forum.