The Trial Master File (TMF) is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations as sponsor for a clinical trial project. This web seminar reviews the sponsor TMF required and additional content for a clinical trial. The activities of set-up, maintenance, and quality control and assurance will be discussed along with common deficiencies and challenges. This web seminar will also include handouts and discussion of the TMF Reference Model.
- Discuss the changing regulatory climate and apply this to the essential documentation practices of a sponsor of clinical trials
- Examine the required components of a TMF
- Recommend policy for the TMF
- Discuss maintenance and quality control of the TMF
- Project Managers
- Quality Assurance Personnel
- Policy Development and Maintenance Personnel
- Sponsor/CRO Personnel involved in the policy, set-up, maintenance, auditing of the TMF
Donna Dorozinsky, R.N., M.S.N., C.C.R.C.
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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.
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#: 0778-0000-15-016-L01-P. Released: 1/15.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.