Article | July 23, 2021

How To Ensure Your Trial Master File's Audit Trail Is Inspection-Ready

Source: Phlexglobal

By Marion Mays

Management audit iStock-1006625398

Regulatory agencies are increasingly looking at the TMF audit trail to gain greater insight into data integrity. We review practical steps to help ensure that your TMF audit trail is ready for inspection, based on regulatory guidelines and lessons learned from actual inspections.

Data integrity is one of the biggest issues facing regulatory agencies today, leading to the audit trail for some documents coming under review more frequently during inspections. This added scrutiny is especially common when the inspector believes documents do not meet mandated requirements, or that there was a failure to follow proper procedure - bringing the information contained within those documents into question.

To better understand the reasons behind this increased scrutiny, its helpful to review these key excerpts from relevant regulatory requirements.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Clinical Leader? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: