Compliance Review

The Compliance office is assigned as an ancillary reviewer on initial submissions or modifications that add the following types of requirements to conduct a research compliance review:

• Use of protected health information
• Clinical research billing
• Use of drugs
• Use of devices
• Clinicaltrials.gov registration
• NIH clinical trials
• International Conference Harmonization Good Clinical Practice (ICH GCP E6 R2)

The Compliance staff will review the submission to determine if the additional requirements apply. Comments may be generated if clarification or explanations are needed.

More Information

For more information about the additional requirements, see the following HRPP Manual sections:

• 2-2-F-i, U.S. Department of Health and Human Services, National Institutes of Health Definition of a Clinical Trial

• 2-2-F-ii, U.S. Department of Health and Human Services, National Institutes of Health Good Clinical Practice Training

• 2-4, International Conference on Harmonization-Good Clinical Practice (E6)

• 7-1, Research Involving Investigational Drugs and Devices

• 7-6, Health Insurance Portability and Accountability Act Compliance in Human Research

• 7-8, Clinical Research Billing Compliance