Clinical Research Training

The following training opportunities are offered by the Human Research Protection Program and the Institutional Review Board (IRB)

CITI Training

CITI Training  is required of all staff and faculty before conducting clinical research.

 

Human Research Regulatory and Oversight

This video series includes the following:

  • About the Human Research Oversight Program
  • The Proper Use of a Regulatory Binder
  • Five Tips: Why Human Research Application are Tabled by the IRB 

 

IRB/HRPP Education and Client Services

The IRB & HRPP offers the Wake Forest School of Medicine Research Community and its affiliates a "Client Services" program which includes on-site education and web-based education modules.

Study-Specific Regulatory and Procedural Guidance

  • Telephone or in-person consulting
  • Guidance on the development and completion of electronic submission

    Please contact Dr. Joseph Andrews PhD with questions at jandrews@wakehealth.edu.

 

Navigating the FDA Regulatory Requirements

This three-part video series provides an overview of best practices for navigating the regulatory maze of the FDA, including:

  • Help with complex regulatory requirements for new drug (IND) and device (IDE) development;
  • Learning how to optimize your communication with the FDA for IND and IDE applications; and
  • Useful tools and resources necessary for finding successful pathways from discovery to clinical implementation. 

    Learn more about IND/IDE Navigation Services.