Take advantage of our $765.000 price by registering early!
* After Friday, March 5, 2021, costs are $945.000.
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.
- Describe the required components of a 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 strategies
- 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
- Clinical Operations Administrators
- Quality Assurance Personnel
- Sponsor and CRO personnel involved
in set up, maintenance, and auditing of the Trial Master File for sponsors
W. Dorozinsky, R.N., M.S.N., C.C.R.C.
Click here for complete trainer
Day 1: 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 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
- 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
$850 by Early Bird Deadline
$1,050 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
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-19-063-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1