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, 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.
- 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-organize Trial Master File
- Examine the importance of a well-written Standard Operating Procedure for Trial Master Files
- Investigate common deficiencies in filing systems
- Participate in filing some key documents and discuss the rationale for the placement of such documents
- 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
Gary B. Freeman, M.S., C.C.R.A.
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Day One: 9:00 a.m. – 4:00 p.m. Eastern (Lunch Break will run from approximately 12:00 - 1:00 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 Participant
- 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 workrelated document samples, and will have the opportunity to evaluate these in light of best practices and GCP standards
$800 by Early Bird Deadline noted in Upcoming Courses section above
$1,000 after Early Bird Deadline
This course is for individual registrants only and does not allow for group training. All participants are eligible for "Certificates of Attendance," and accreditation, provided that accreditation requirements are met.
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 mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-017-L01-P. Released: 3/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.