Course Description

The Trial Master File is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations for a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50 that, “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.” The European Directive 2005/28/EC states that, “the trial master file shall consist of essential documents.” R2 Guideline, Section 8.1 defines these essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. They are all also eligible for inspection by the regulatory authorities at any time during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics and devices. It is, therefore, paramount that these documents are filed in a way to make them immediately accessible for use by the study team and for regulatory inspection. This module will provide some practical solutions to meet these challenges.

Participants will review the content that is required of a Trial Master File for drugs and devices for a clinical trial, and will acquire a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor.

The activities of set-up, maintenance, and quality review will be discussed, as well as common deficiencies and challenges. The need for an effective Standard Operating Procedure (SOP) will also be examined.

In today’s regulatory environment, the files must be “inspection ready” at all times. Regulatory authorities may conduct a regulatory inspection at any time throughout the life of the study. Therefore, the timely filing and organization of these documents is of utmost importance. There needs to be a consistent system employed such that documents can be located and provided for study team use as well as regulatory inspection in a timely manner.

Learning Objectives

• Describe the required components of a Trial Master File
• Recognize the importance of a well-organized Trial Master File
• Implement strategies for effective filing of required documents
• Identify processes that support the effective management of the Trial Master File
• Investigate common deficiencies in filing systems
• Participate in filing some key documents and discuss the rationale for the placement of such documents

Who Should Attend

• Lead Clinical Research Associates
• Clinical Research Associate Managers
• Project and/or Study Managers
• Project and/or Clinical Trial Assistants
• Clinical Operations Administrators
• Quality Assurance Personnel
• Sponsor and CRO personnel involved in set up, maintenance, and auditing of the Trial Master File for sponsors

Instructor

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

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

Jim Markley

Laura Wiggins, M.B.A.

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Course Outline

• Required Components of Trial Master File
• Set Up and Maintenance of a Trial Master File  
• SOP Review and Critique  
• Practical Experience Filing Using a Sample Trial Master File  
• Discussion of Common Deficiencies and Review of Challenges Presented by Participants  

Interactive Activities

• The pitfalls and challenges encountered in setting up a Trial Master File
• The challenges in maintaining an effective Trial Master File
• Outline a Trial Master File Management Standard Operating Procedure
• Participate in filing of sample documents using the Drug Information Association Trial Master File Reference Model
• Discuss the value of filing Trial Master File content appropriately
• Learners are encouraged to bring specific work-related document samples, and will have the opportunity to evaluate these in light of best practices and GCP standards

Registration Fees

This course is for individual registrants only and does not allow for group training.

Special rates are available for multiple attendees from the same organization.  Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 6 hours (0.6 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#: 0778-0000-23-030-L99-P. Released: 6/23.

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