TMF/eTMF Audit Strategies

Course Description

The process for managing the Trial Master File (TMF) has changed drastically in the last 10 years. Many organizations have moved to an electronic TMF (eTMF), yet some organizations still operate with a paper TMF or a hybrid of the two. A successful audit evaluates the processes that were used to manage the TMF to ensure that they are consistent with procedural documents and study plans. This web seminar will present a strategy for conducting a TMF audit that identifies gaps that have potential impact on the quality of the TMF. We will explore strategies for using the power of an eTMF to identify gaps that could result in inspection findings. The power of the TMF Reference Model in organizing the audit and identifying key artifacts that potentially impact Good Clinical Practice (GCP) compliance will also be discussed. Finally, we will examine strategies for the audit of a paper TMF as well as an eTMF, including critical files to review and how to spot trends in non-compliance.

Learning Objectives

• Explain the value of the TMF Reference Model in organizing an audit to ensure efficient identification of GCP non-compliance
• Identify strategies for conducting an audit of an eTMF that employ the enhanced capabilities of an eTMF
• Identify strategies for auditing a TMF that focuses on artifacts impacting the quality and GCP compliance of the TMF/eTMF

Who Should Attend

• Good Clinical Practice Auditors
• Trial Master File Directors
• Trial Master File Managers
• Trial Master File Coordinators
• Clinical Operations Directors
• Trial Managers
• Records Management Team Members

Instructor

Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-21-051-L04-P. Released: 10/21. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.