Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance.
- Define clinical research essential documentation
- Determine essential subject and non-subject specific documentation requirements per trial
- Discuss essential documentation for drug vs. device vs. combination products
- Prepare for regulatory inspection: Proactive and reactive use of essential documentation
- Clinical Research Coordinators
- Principal Investigators
- Research Site Managers
- Clinical Research Associates
- Quality Assurance Personnel
- Project Managers
- Clinical Research Associate Managers
This course will be taught by one of the following instructors:
Nikki Christison, B.S., C.C.R.A.
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
Click here for complete trainer biographies
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 2.5 hours (0.25 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#: 0778-0000-14-056-L01-P. Released: 11/14.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.