Essential Documentation in Clinical Trials at Research Sites
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
Who Should Attend
- Clinical Research Coordinators
- Principal Investigators
- Research Site Managers
- Clinical Research Associates
- Quality Assurance Personnel
- Project Managers
- Clinical Research Associate Managers
Marla Hoelle, BSN, RN, CCRA, ACRP-PM, PMP
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.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: firstname.lastname@example.org
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 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#: 0778-0000-20-034-L01-P. Released: 1/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.