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UPCOMING LIVE SEMINARS
 
Monitoring Clinical Drug Studies: Beginner
August 26-28, 2014
Philadelphia, PA
Clinical Project Management: Advanced
September 10-11, 2014
San Diego, CA






Trial Master File (TMF) for Sponsors: Set Up and Maintenance

Upcoming Courses
Course #: BI11716
September 4, 2014
8:30 AM - 10:30 AM Eastern
$795.00
Course #: BI11767
October 17, 2014
12:00 PM - 2:00 PM Eastern
$795.00
Course #: BI11795
November 17, 2014
12:00 PM - 2:00 PM Eastern
$795.00
Course #: BI11845
January 13, 2015
12:00 PM - 2:00 PM Eastern
$795.00

Course Description

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 course will also include handouts and discussion of the TMF Reference Model.

Learning Objectives

  • 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

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

Gary B. Freeman, M.S., C.C.R.A. 

Click here for complete trainer biographies 

Registration Fees

$795

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 1-800-856-2556 for pricing.

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 mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-12-034-L01-P. Released: 3/12. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.