From: Lisa Mulcahy [mailto:mulcahy67@comcast.net]
Sent: Friday, August 08, 2014 10:55 AM
To: etmf-comment@lists.oasis-open.org
Subject:
Investigator site artifacts are left out. This is inappropriate as per the ICH Guidelines and MHRA - The TMF is normally composed of a sponsor file, held by the sponsor organisation, and an investigator site file, held by the investigator. These files together are regarded as comprising the entire TMF for the trial and should be established at the beginning of the trial.
Sincerely,
Lisa Mulcahy
412-213-3050