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.
- 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
- 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
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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biographies
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
- 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 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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cancellation policy
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.