Research@UIC > OVCR Quality Improvement Program > Resources

Resources

General:

1. FDA Information Sheet Guidances -
   Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

For Devices:

1. FDA Device Advice - site for obtaining regulatory information about medical devices.
   
2. Investigators’ Responsibilities for Significant Risk Device Investigations - FDA Investigator guidance for device trials
3. Sponsor's Responsibilities for Significant Risk Device Investigations - FDA Sponsor guidance for device trials
4. Investigational Device Exemption (IDE) Process
   
5. Summary of FDA Requirements for the Sponsor or Sponsor - Investigator of Research Involving Investigational Devices

For Drugs:

FDA - site for obtaining regulatory information about investigational drug

1. Investigational New Drug (IND) Application Process
   
2. Clinical Investigator Forms - site for obtaining FDA forms involving investigational drugs  
3. FDA  Clinical Investigator Inspection List (CLIIL) - Investigational Human Drugs
4. Summary of FDA Requirements for the Sponsor or Sponsor - Investigator of Research Involving Investigational Drugs

Good Clinical Practice:

1. Good Clinical Practice in FDA-Regulated Clinical Trials
   
2. Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance -
   Section 4 is a 23-page description of investigator responsibilities

Noncompliance findings:

1. OHRPs common noncompliance findings
   
2. FDA Warning Letter
   

Last updated: Thursday, October 08, 2009.