Regulations and Guidance

The Clinical Trials Audit and Compliance department reviews clinical trials at Emory to ensure compliance with the written protocol, federal regulations, sponsor requirements, and Institutional policies.

Emory has adopted the following NIH definition of a clinical trial: A biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

Regulations

Not all regulations pertain to every clinical trial. The most common federal regulations pertaining to human subject protections are listed below.

  1.  45 CFR 46 (Subpart A is also known as "The Common Rule") applies to trials that are supported by the Department of Health and Human Services
  2.  21 CFR 50 and 21 CFR 56 apply to trials that use FDA-regulated products as part of the research question
  3. 21 CFR 312 applies to trials being conducted under an Investigational New Drug (IND)
  4. 21 CFR 812 applies to trials being conducted under an Investigational Device Exemption (IDE)
  5. 38 CFR 16 applies to trials being conducted or supported by the Department of Veterans Affairs

Federal Guidance

Federal regulations do not change much over time, but interpretation of the regulations may change. Federal agencies publish guidance documents to show current thinking on challenging regulatory topics. Links to federal agency guidance documents are listed below.

  1. Office of Human Research Protections (OHRP) Policy and Guidance
  2. Food and Drug Administration (FDA) Clinical Trials Guidance Documents
  3. International Conference on Harmonization Guidelines

Sponsors

Each Sponsor will have their own requirements as far as what needs to be reported to them, what may need to be reported to the IRB (above and beyond the Emory IRB requirements), and timely case report form completion. You may find your Sponsor's requirements in the Sponsor documentation, on their website, or in the clinical trial agreement. If requirements differ between the institution and Sponsor, always adhere to the stricter requirements. Ask your monitor or Sponsor representative about Sponsor-specific requirements at the site initiation visit.