Saint Louis University

 

Getting Started: IRB Process at a Glance

General Guidelines for Conducting Research at SLU 

Tips for Choosing the Appropriate IRB Application

 

Investigator Initiated Clinical Research:

  • CITI Good Clinical Practice (GCP) Training: 

While not required by SLU, many industry sponsors mandate the completion of GCP training with refresher training every three years. In addition, the NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials (NOT-OD-16-148, effective date January 1, 2017), mandates GCP training every three years. SLU clinical researchers are able to take the CITI GCP training to satisfy these requirements. Researchers outside of a sponsor mandate are also encouraged to take the GCP Course in CITI to learn more about regulations that are unique to clinical trials and the importance of using good clinical practice in the conduct of clinical research. NOTE: GCP course completion does not count toward the mandatory IRB/Human Subjects Protections education requirement.

See the Training and Education page for more information about registering for CITI training.

 

Checklists and Decision Trees:

Additional Criteria Checklist: Department of Defense 

Additional Criteria Checklist: Department of Education 

Additional Criteria Checklist: Department of Energy

Additional Criteria Checklist: Department of Energy - PI Checklist

Additional Criteria Checklist: Department of Justice

Additional Criteria Checklist: Environmental Protection Agency

Additional Criteria Checklist: Investigational Devices

Additional Criteria Checklist: Investigational Drugs

Additional Criteria Checklist: Sponsor Investigator Responsibilities

Checklist: Human Research Determination

Checklist: Eligibility for Exempt Review

Checklist: Eligibility for Expedited Initial Review

Checklist: Eligibility for Expedited Continuing Review

Checklist: Obtaining Consent in 45 CFR 46.406/21 CFR 50.53 Research

Decision Tree: Protocol Violation

Decision Tree: Serious Adverse Event

Decision Tree: Unanticipated Problem