Regulatory Affairs

The Food and Drug Administration has numerous regulations and guidance documents for investigators in their responsibilities for conducting FDA regulated research; investigators should have a thorough understanding of their role and responsibilities and how it relates to the protection of research participants. Research professionals are continuously challenged by the evolving regulatory landscape and the increased risk associated with the complexity of research protocols.

The CTSC can provide investigators with awareness of regulatory requirements and acceptable standards for the conduct of clinical trials and the protection of human subjects. We can help investigators understand the function of the FDA and Investigator responsibilities for those holding Investigational New Drug (IND) applications or Investigational Device Exemptions (IDE) or those investigators conducting research under and IND or IDE.

Clinical Investigators: View the September 2013 IND guidelines that have been recently been posted on the FDA/CDER website: [Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND]

September 2013 IND guidelines: