Event Details

ISCR Virtual Workshop – eTMF (electronic Trial Master File)

23 Oct 2021-23 Oct 2021,

Title: eTMF (electronic Trial Master File)
Highlights: A TMF is the collection of essential documents that is used by sponsors, CROs and investigators/institutions for the management of the trial and by monitors, auditors and inspectors to review and verify whether the sponsor and the investigators/institutions have conducted the trial in line with the applicable regulatory requirements and the principles and standards of GCP. The documentation contained within it should be sufficient to adequately reconstruct the trial activities undertaken, along with key decisions made concerning the trial. eTMF is a way of digitally capturing, managing and storing essential documents and content in clinical trial. In this workshop, you will gain knowledge about how to keep your eTMF inspection ready and will learn about Best practices. You will also engage yourself in determining how completeness and accuracy can be ensured while engaging yourself in live demo session.
The learning objectives will be to:
• Gain insight on regulations around eTMF
• To understand Industry Best practices used in eTMF management & eTMF Health Metrics
• Proactive eTMF risk assessment approaches in keeping eTMF inspection ready
• How technological advancement will change the future of eTMF




Indian Society for Clinical Research

The Capital, 1802, 18th Floor,
Plot No. C-70,'G'Block,
Bandra Kurla Complex,
Bandra(E), Mumbai - 400 051