Compliance & Monitoring

Research Administration (RA) performs periodic compliance reviews to evaluate adherence to applicable regulations, laws and policies, and to verify that research is conducted and documented in accordance with IRB-approved protocols.

Internal

Planned Compliance Reviews

RA will complete a requisite number of randomly selected periodic reviews of researcher’s activities to ensure overall compliance, understanding of the protocol procedures and an understanding of IRB requirements.

For-Cause or Directed Reviews

The IRB or Seton Research Enterprise leadership may direct the RA Team or other designees to conduct a review of research records and activities in response to a particular concern.

External

FDA Inspection

FDA conducts clinical investigator and sponsor-investigator inspections to determine if clinical studies are being conducted in compliance with applicable regulatory requirements. Clinical investigators who conduct human subject research with FDA-regulated investigational or approved drugs are required to permit FDA investigators to access, copy and verify any records or reports made by the clinical investigator with regard to, among other records, the disposition of the investigational product and subjects’ case reports.

Other Activities Include

Tools for Researchers: The Research Support Services (RSS) Team develops checklists, templates and tools to assist researchers with compliance to applicable requirements and self-assessments.

Communication with RSS: The RSS and Sponsored Projects Finance Teams meet regularly with researchers and study teams to discuss the application of new or existing regulations and policy, relevant compliance issues and to reinforce relevant policies and practices.