Norton Training Institute builds strong regulatory and legal skills necessary for each research professional. There are binding and legal agreements between the FDA, Sponsor, IRB and the clinical investigator as well as each study team member. This program will help the monitor, investigator and study team, auditors, review board members, and other research professionals understand the requirements for determining the investigator's necessary qualifications for receiving investigational drugs and conducting clinical research.

The program examines 21 Title CFR (United States Code of Federal Regulations) 312 and other parts, FDA's Compliance Policy Program 7348.811 on Clinical Investigators, and International Conference on Harmonisation as related to determining investigator's qualifications to receive and treat with investigational drugs.

The meaning and use of the Form FDA-1572, Statement of Investigator, will be examined both in a legal manner and for undertstanding the form as a ‘Team Plan’ for describing the qualifications of the study team to perform clinical protocols. Each individual or facility listed details where, how, and who will conduct the required activities for the protocol. This ‘Team Plan’ is paramount for describing the training and experience of the study team.

Course Lessons Include:

1. Legal Training for Determining Qualifications
2. Definitions and Interpretations
3. Responsibilities of Sponsors and Investigators
4. FDA's Bioresearch Monitoring Program
5. FDA's Compliance Policy 7348.811; Clinical Investigator
6. Inspection Procedures
7. General Responibilities of Investigators
8. Selecting Investigators and Monitors
9. Obtaining Information from the Investigator
10. International Conference on Harmonisation
11. Failure to Adequately Supervise Clinical Trials
12. Violating the Food Drug and Cosmetic (FD&C) Act

Build the regulatory and legal skills necessary to understand the binding and legal agreements between the FDA, Sponsor, IRB, and the clinical investigator and study team members, which govern the investigator's necessary qualifications for receiving investigational drugs and conducting clinical research. The program examines 21 Title CFR 312, FDA's Compliance Policy Program 7348.811 on Clinical Investigators, Form FDA-1572, and International Conference on Harmonisation as related to determining investigator's qualifications to receive and treat with investigational drugs.

1 1/2 hours of Education for the entire Research Community including Investigators, Monitors, Auditors, Coordinators, and IRB Members.
1.5 Contact Hours or 0.2 CEUs
$95.00