Regulatory Support

Consultation and Training

Staff in our Clinical Research Resources Office (CRRO) are available for one-on-one consultations or training sessions with groups of researchers to help prepare IRB applications, respond to IRB stipulations, or get help with study implementation, ect.

Quality Assurance Reviews

Under the authority of BMC and BUMC, the CRRO conducts routine quality assurance (QA) reviews as well as for-cause audits. The overall aim of QA reviews is to protect the rights and welfare of research study subjects as well as ensure the validity and reliability of the data.

Routine QA reviews may be initiated with a request from a principal investigator or after being selected by the CRRO for review from a list of recently Internal Review Board (IRB)-approved studies. Priority for selection is given to studies that are greater than minimal risk, investigator-initiated and have prospective research interventions, but any study may be chosen for review.

For-cause audits are initiated following a request from the IRB director, the IRB Executive Committee, or the BMC Institutional Official, or the BUMC Institutional Official. Typically a for-cause audit is requested because of some concern with regards to study conduct and compliance or in response to a complaint. For more information, click here.

IND/IDE Submission Support

The CRRO assists investigators with guidance and support on submissions of investigational new drug (IND) applications and investigational device exemptions (IDEs) to the FDA. This includes guidance with sponsor-investigator responsibilities and obligations in conduct of IND/IDE research, assistance with preparation and submission of IND/IDE applications to the FDA, and management of IND/IDEs.