Onsemble Conference Review: Effort Tracking, 21 CFR Part 11, More

Lisa Haddican
November 15th, 2013

The Onsemble 2013 Fall Conference was held September 18-20 and was co-hosted by Yale University. It was attended by more than 200 clinical research professionals, and featured discussion on popular topics. The topics included common misconceptions surrounding 21 CFR Part 11, risk-based monitoring, staff effort tracking, and more.

If you missed the conference or would like to review the presentations again, here is a quick review of popular session topics and resources for learning more.

1) Addressing Common Misconceptions about 21 CFR Part 11

Robert Finamore, Director of IT and Compliance at QPharma, Inc., presented on the topic of 21 CFR Part 11, which is a federal regulation published by the FDA and establishes requirements to ensure that Electronic Records and Electronic Signatures have equivalent controls for authenticity, integrity, accountability, and confidentiality as hardcopy records and signatures.

He addressed many common misconceptions such as 21 CFR Part 11, including:

  • “Part 11 does not apply to my computerized system”;
  • “Part 11 does not apply because we use paper as our official records”;
  • “The system records my User ID and a time stamp when I click the Approve button and that’s an electronic signature”

2) Approaches to Risk-Based Monitoring

This presentation discussed the FDA guidance for risk-based monitoring of clinical trials. Presenters from the UNC Lineberger Comprehensive Cancer Center and the Seidman Cancer Center also discussed a tool that has been developed to help institutions assess the risk of trials.

3) Staff Effort Tracking

Presenters from the University of Iowa Holden Comprehensive Cancer Center and the University of Indiana Simon Cancer Center focused on how they have implemented effort tracking to more effectively manage staff workloads. The presenters walked through their methods for tracking effort, which included gaining staff participation and evaluating trial complexity.