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, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.” ICH GCP E6 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 assurance 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 “audit ready” at all times. Regulatory authorities may contact the sponsor and request a particular document be provided to them for inspection. 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
Implement strategies for effective filing of required documents
Effectively manage the Trial Master File
Recognize the importance of a well-organized 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.

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Course Outline

Day One: 9:00 a.m. – 4:00 p.m.

Required Components of a 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
Critique a Standard Operating Procedure established as a sample policy
Participate in actual filing of sample documents using the Drug Information Association Trial Master File Reference Model
Discuss the value of proper filing of documentation related to the Trial Master File
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

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

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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#: 0778-0000-19-063-L01-P. Released: 10/19.

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