Independent Quality Checks/Audits

Independent Quality Checks/Audits Support we provide: 

• Review of Regulatory Documents
• Review of Inclusion/Exclusion Criteria and Consent Documentation of all study participants
• Source verification for up to two study participants
• Full Quality Audit for Audit Preparation

Independent Quality Checks/Audits allow for review of study conduct early in the research process. This allows for direct constructive feedback, recommendations and training for the remaining study conduct.  

Independent Quality Checks/Audits may also be completed towards the end of the study for a more extensive look at the study conduct, to prepare for an FDA inspection or sponsor audit. 

When is an Independent Quality Check/Audit Needed?

Independent Quality Checks/Audits are suggested for newer researchers who are conducting their first research study. This allows a researcher to gain valuable insight on how their study is progressing.  

Independent Quality Checks/Audits may also be requested by the study PI to evaluate the study conduct and prepare for an FDA inspection or sponsor audit. This request should be scheduled well in advance of a notice of inspection/audit.

Independent Quality Checks/Audits may be completed for clinical research studies funded through the NCATS UM1 awards.