Research Resources

Quality Assurance

The Regulatory Affairs/Quality Assurance team (Reg/QA team) conducts internal research audits of human subject research, supports external audits and Regulatory Agency (RA) research inspections, and otherwise provides QA support to the research community.

Research Investigator Audits and Inspections Policy v.1 

If a PI or research team is notified of selection for a Regulatory Agency Inspection, contact the Reg/QA team immediately for guidance and support at ResearchRegQA@luriechildrens.org. 

Types of RA Inspections

U.S. Food and Drug Administration (FDA) Bioresearch Monitoring (BIMO) Program 

The FDA BIMO program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research.  

The BIMO program was established to:

  • assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications.
  • provide for protection of the rights and welfare of the thousands of human subjects and animals involved in FDA regulated research.
  • perform pharmacovigilance activities for postmarketing drug products. These activities serve to detect, understand, and prevent drug-related problems.

The BIMO program has become a cornerstone of the FDA preapproval process for new medicines, medical devices, food and color additives, veterinary products and, tobacco products introduced to the U.S. consumer. 

European Medicines Agency (EMA) Good Clinical Practice (GCP) Inspection 

The GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the EMA Committee for Medicinal Products for Human Use (CHMP) in the context of the centralized procedure.

These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier, or by other information such as previous inspection experience. Inspections are usually requested during the initial review of a marketing authorization application, but could arise post-authorization (e.g. inspection of studies conducted or completed as part of the condition of a marketing authorization, or because of concerns arising about the studies previously submitted).

Research study teams may be selected for several types of External Audits.

If a research team is notified of selection for an External Audit, contact the Reg/QA team immediately for guidance at ResearchRegQA@luriechildrens.org. 

Examples of External Audits: 

  • Routine/Good Clinical Practice (GCP) audit: conducted by Sponsor or Contract Research Organization (CRO)
  • National Cancer Institute (NCI)/ National Clinical Trials Network (NCTN)/ Children's Oncology Group (COG) audit: document the accuracy of data submitted to the Network Groups (COG) and to verify investigator compliance with protocol and regulatory requirements
  • For-cause audit: triggered by specific events or concerns that arise during the conduct of a trial
  • Close-out audit: conducted after trial completion, to review the entirety of the trial conduct and data collection

Purpose

The Internal Research Auditing Program is a quality assurance initiative designed to ensure the protection of human subjects, and the quality and integrity of the data and information submitted to the Institutional Review Board (IRB), Sponsor, and Regulatory Agency [e.g. U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)]. It is also designed to confirm that all research that involves human participants at the Medical Center complies with institutional policies and applicable federal regulations, as well as helping to identify needs of the research community at Lurie Children’s. 

Objectives

  • Identify potential areas in need of improvement, correction, or targeted education
  • Provide hands-on, one-on-one review of the conduct of research
  • Create an open dialogue to promote education and sharing of best practices throughout the research community

ORIC views the Internal Auditing Program as an opportunity to connect with the community of PIs and Research Professionals that are conducting research across the Institution. Through this connection, ORIC can learn about how research is being implemented and use this information to improve upon processes and policies. Audits may serve as an opportunity to correct errors in a timely manner to prevent recurrence, reduce risk, and ensure audit readiness.

Quality Assurance Resources for Study Teams

Requesting an Internal Audit 

To request an internal research audit of your research study, contact ResearchRegQA@luriechildrens.org.