CRC 201 - Clinical Research Regulatory Compliance

1. Discuss the historical events that precipitated the development of governmental regulatory processes for investigational products
2. Identify Good Clinical Practice (GCP) Guidelines
3. Summarize the principle methods of balancing risk and benefit through selection of study participants
4. Differentiate between a sponsor audit, an IRB audit, and an FDA inspection
5. Identify the key steps in the drug development/device approval process

1. The Role, Function, and Organization of the Food and Drug Administration (FDA)
   1. Brief history of the FDA
   2. 3-part mission of the FDA
   3. Definitions for major product characteristics
   4. FD&C Act, Code of Federal Regulations, FDA and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidance
   5. How to contact and interact with the agency
   6. Agency role in oversight of clinical studies
2. Compliance with Good Clinical Practices
   1. Overview of ICH Guidelines E.6
   2. Monitoring of clinical research-sponsor obligations and expectations
   3. Routine GCP audits associated with sponsor marketing applications
   4. Handling, understanding, and responding to FDA Form 483
   5. FDA GCP “for cause” audits
   6. FDA’s fraud policy
   7. Regulatory sanctions for noncompliance
3. Regulatory Documentation Requirements for Clinical Studies
   1. Completion of Form FDA 1572 (Investigator’s commitment)
   2. Required Investigator and sub investigator information
   3. Institutional Review Board Approvals as required
   4. Types of studies that require Financial Disclosures
   5. Informed Consent and Re-consent process
   6. Preparation and maintenance of Site Regulatory Binders
   7. Study medication storage and accountability
   8. Archiving of study-related documentation
   9.     Documents required before drug can be shipped
4. Safety Reporting
   1. Routine adverse event reporting
   2. When is an AE a SAE?
   3. SAE reporting obligations to the sponsor, IRB, and other investigators
   4. How to submit 7- and 15-day IND safety reports for SAEs
   5. How to prepare follow-up reports and conduct ongoing safety review
   6. Termination of clinical studies for safety reasons
   7. Use of the Med Watch and Council for the International Organization of Medical Science (CIOMS) safety reporting forms
   8. Drug Safety Monitoring boards
   9. New FDA safety initiatives