8:30–8:45 - SOCRA Welcome
8:45–9:15 - FDA Welcome and Opening Comments Mishelle L. Harriger, Acting Division Director, BIMO Division 1 (Northeast), Office of Inspections and Investigations (OII), FDA
Ms. Harriger will address the mission of FDA and the role of the Office of Bioresearch Monitoring Inspectorate (OBMI) relative to the Bioresearch Monitoring Program.
9:15–10:45 - Knock Knock - The FDA Inspection
D’Arbra Blankenship & Gabrielle Swain, Investigators, BIMO Division 1, Office of Inspections and Investigations, FDA
What do you do when a regulatory agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure that your predesigned systems are working correctly. This presentation will cover FDA Inspections; how to prepare for them, and what to do and expect after the inevitable ‘Knock, Knock’.
10:45–11:00 - Break
11:00–12:30 – Regulatory Requirements: Clinical Investigator’s Responsibilities and the Clinical Research Pharmacist’s Role
Kathryn Suttling, Investigator, BIMO Specialist, BIMO Division 1, Office of Inspections and Investigations, FDA
This presentation will cover clinical investigator regulatory obligations and the clinical research pharmacist's role in compliance, focusing on the five most commonly cited regulations in FDA Form 483s. Ms. Suttling will share strategic questions designed to foster best practices that strengthen patient safety and improve data quality.
12:30–1:30 - Lunch
1:30–2:15 - A Continuing Evolution of Ethical Considerations in Clinical Research
Alyssa K. Gateman, MPH, CCRP, Executive Director, Yale Cancer Center Clinical Trials Office
This presentation examines how ethical principles in clinical research have developed over time and continue to evolve in response to scientific and societal changes. Topics include foundational ethical frameworks, specifically the recent revisions to the Declaration of Helsinki, and the challenges of ensuring equitable access to investigational treatments. Through case studies and discussion, participants will explore real-world dilemmas and the responsibilities of various stakeholders in protecting patient rights and promoting justice in research.
2:15- 2:30 - Break
2:30-3:30- Quality by Design
D’Arbra Blankenship & Gabrielle Swain, Investigators BIMO Division 1, Office of Inspections and Investigations, FDA
Ms. Swain and Ms. Blankenship will discuss the principles of Quality by Design, as described in ICH E8(R1) General Considerations for Clinical Studies, and in the FDA’s draft ICH E6(R3) Good Clinical Practice guideline. Case study will demonstrate how applying good design principles can contribute to both improved trial design and tailored trial oversight.
3:30–4:00 - Question and Answer Session / Panel Discussion
8:30-9:30 - FDA Conduct of Clinical Investigator Inspections
Meredith Miller and Gabrielle Swain Investigators, BIMO Division 1, Office of Inspections and Investigations, FDA
The investigators will explain the responsibilities of the Clinical Investigator including the regulations and guidelines to which the FDA expects the Clinical Investigator to adhere in their participation, review, and oversight of clinical investigations.
9:30-10:30 - IRB Regulations and FDA Inspections
Kathryn Suttling, Investigator, BIMO Specialist, BIMO Division 1, Office of Inspections and Investigations, FDA
Ms. Suttling will discuss FDA regulations covering the operations of Institutional Review Boards, the procedures used by FDA investigators during inspections of IRBs, the Common Rule, and FDA enforcement options.
10:30-10:45 - Break
10:45-11:45 - Informed Consent Regulations
Meredith Miller, Investigator, BIMO Division 1, Office of Inspections and Investigations, FDA
Ms. Miller will discuss regulations addressing the Informed Consent process and documentation from the investigator’s point of view.
11:45-12:30 – Improving Informed Consent - Informed Consent Draft Guidance
Gabrielle Swain, Investigator BIMO Division 1, Office of Inspections and Investigations, FDA
Ms. Swain will discuss the 2024 FDA draft guidance: Key Information and Facilitating Understanding in Informed consent.
12:30 – 1:30 - Lunch
1:30-2:15 - Decentralized Clinical Trials
D’Arbra Blankenship, Investigator, BIMO Division 1, Office of Inspections and Investigations, FDA
Ms. Blankenship will provide an overview of decentralized clinical trials (DCTs) along with the FDA’s current regulations and guidance. The presentation will address the perceived and/or actual benefits and challenges of decentralized clinical trials. The speaker will discuss the oversight of DCTs and key issues to consider.
2:15 – 2:30- Break
2:30 – 3:30 - BIMO Compliance and Enforcement
Mishelle Harriger, Acting Division Director, BIMO Division 1, Office of Inspections and Investigations, FDA
Ms. Harriger will cover Fiscal Year 2024 metrics and selected regulatory actions taken by the Agency.
3:30- 4:00 - Question and Answer Session / Panel Discussion