Becoming a Clinical Research Investigator: Roles, Responsibilities and Successful Clinical Trial Management

Course Description

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.

Learning Objectives

• 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
• Sub-Investigators
• Clinical Research Team Members wanting to better understand the clinical investigator role and responsibilities in clinical research

Instructor

Marla Hoelle, BSN, RN, CCRA, ACRP-PM, PMP

Click here for complete trainer biographies

Registration Fees

$735

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.

Accreditation Information

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.