Becoming a Clinical Research Investigator: Roles, Responsibilities and Successful Clinical Trial Management
This web seminar has been designed for the clinical investigator seeking an understanding of their role and responsibilities in the conduct of clinical trials. We will focus on the investigator’s responsibility to ensure human subject protection and data integrity in the conduct of clinical trials. Specific topic areas include: Delegation to and oversight of clinical research teams, FDA regulations and appliable guidance documents, Good Clinical Practice (GCP), ICH GCP E6 R2, adverse events, and FDA inspections and sponsor audits.
- Describe the clinical investigator roles and responsibilities in the conduct of human clinical trials
- Identify appropriate investigator delegation and oversight
- Define GCP and ICH GCP E6 R2 requirements for clinical investigators
- Recognize adverse events and reporting requirements in clinical trials
- Define types of FDA inspections and sponsor audits
Who Should Attend
- Clinical Investigators
- Clinical Research Team Members wanting to better understand the clinical investigator role and responsibilities in clinical research
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 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#: 0778-0000-20-092-L04-P. Released: 9/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.