Course Description

The Trial Master File (TMF) is a collection of the essential documents for a sponsor to demonstrate that they have fulfilled their obligations as sponsor for a clinical trial project as defined by the health authorities. This web seminar reviews the activities that a sponsor uses to set-up, maintain, and perform oversight of the TMF. It examines the changing regulatory landscape that defines sponsors responsibility in managing the TMF. This web seminar will also include handouts and discussion of the TMF Reference Model.

Learning Objectives

• Discuss the changing regulatory climate and apply this to the TMF management practices of a sponsor of clinical trials
• Examine the required components of a TMF
• Recommend policy for managing and providing oversight to the TMF
• Discuss maintenance and quality control of the TMF

Who Should Attend

• Project Managers
• Quality Assurance Personnel
• Policy Development and Maintenance Personnel
• Sponsor/CRO Personnel involved in the policy, set-up, maintenance, auditing of the TMF

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies

Registration Fees

$835

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 2 hours (0.2 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#: 0778-0000-23-073-L99-P. Released: 10/23. 

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