Trial Master File Reference Model Discussion Forum

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April 30, 2020 at 5:59 pm in reply to: List of Research Grants and Fellowship Awards in CVs #3567

Barbara Manion
Participant

Thank you both for your comments. They are in line with my opinions and will help to confirm guidance communication to our team. We strive for 100% compliance, and this forum has certainly helped us maintain that goal.

January 29, 2020 at 6:45 pm in reply to: Best Practice: Wet-Ink Signatures & Certified Copies #2815

Barbara Manion
Participant

Thank you, Karen. I appreciate your response. Our SOP is in revision so we are simply trying to figure out the best practice in the interim.

January 29, 2020 at 6:15 pm in reply to: Best Practice: Wet-Ink Signatures & Certified Copies #2811

Barbara Manion
Participant

If the official repository for an electronic-based study is the eTMF, and wet-ink documents are validated per the application, do we need to file wet-inks in a paper TMF or QC Files?
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