MCC Inspection Readiness/TMF Community of Practice Discusses Challenges of Conducting TMF QC

Friday, June 25, 2021

At the bi-monthly virtual meeting on 8-Jun-2021, we had panelists Ashley Appleton (Eli Lilly), Dawn Niccum (inSeption), Robert Toal (IQVIA), and LoriAnn Verna (Just In Time GCP) exploring the topics of TMF QC. There was high interest in the topic with record registrations and many questions and comments from attendees. Areas discussed included the frequency of QC, the practicalities of QC, definitions of terms such as “duplicate”, and the potential for using Natural Language Processing to assist with filing. The meeting included live polling which revealed that 44% of those who responded do not typically carry out root cause analysis when the TMF QC does not meet the required standard. This generated discussion on the panel.

Additional information about this group can be found by visiting the MCC Inspection Readiness/TMF Community of Practice page. MCC members can log in to the member portal to view the recorded session.

Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.