Research@UIC > OVCR Quality Improvement Program > Resources

Resources

General:

1. FDA Information Sheet Guidances - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
2. What will a FDA investigator be looking for during an inspection (Sponsor/CRO/Monitors perspective)?

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. 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

For Clinical Trials Registration:

1. Presentation on May 26, 2010 by Dr. Rebecca Williams - ClinicalTrials.gov - Registration and Results Reporting Requirements
   

Last updated: Monday, November 08, 2010.