the big picture of how essential study documents impact the approval and ethics
of a clinical research trial often gets overlooked in the rush of document
collection and requests. The foundation of this web seminar is the site study
file, what the documents are, and why they are important as related to the ICH
GCP E6 Guideline Essential Documents and 21 CFR 50, 54, 56 and 312. This web
seminar will also provide a reference point for why the paperwork is so critical
within the process of a study.
- Describe the investigational product development
process and the role of documentation
- Discuss the roles and
responsibilities during the study document handling process
- Review the importance of study files
and essential documents handling including review of FDA audit findings
- Study Coordinators
- Site Regulatory Managers
- Clinical Research Associates
- Project Assistants
- Regulatory Assistants
- Site Managers
This course will be taught by one of the following instructors:
Christison, B.S., C.C.R.A.
Debbie Harper, B.Sc., P.M.P.
Click here for complete trainer
Includes up to 20
participants at one site. All participants (up to 20) are eligible for
“Certificates of Attendance,” and accreditation, provided that accreditation
requirements are met. For groups larger than 20 or for additional sites, please
call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 1.5 hours (0.15 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#: 0778-0000-18-056-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1