QA/QI

Researcher Services

We offer a variety of services to assist our researchers and their research teams:

• External Audit Preparation Assistance (FDA, NIH, or other external agency)
• Research Records Education & Training (USF and USF-affiliate researchers and their staff) regarding best practices for maintaining human subject research records for all IRB-approved studies under the oversight of the USF Human Research Protection Program
• Corrective and Preventative Action (CAPA) Plan Development in order to facilitate investigator responses to identified noncompliance
• On-site Consultations to assist in setting up new studies or monitoring ongoing studies
• Annotated Study Binders to facilitate documentation of human subject research activities
• External Audit Response - Assistance including regulatory guidance and development of corrective and preventative action plans to prevent future non-compliance (e.g. response to FDA-483 or FDA Warning Letter)
• Study Team Tools to facilitate documentation of research activities (self-assessment checklists, study logs, etc.)