Program Information:
This virtual symposium is a distinct opportunity for Sponsor-Investigators and key research staff to receive targeted training directly from FDA, NIH, and research industry representatives. It will provide insight into the unique dual-role of sponsor-investigators with in-depth coverage of the applicable FDA regulations, guidelines, and best practices. Attendees will take away tools for designing and managing quality research studies that will produce accurate and complete data submissions. The two (2) full-day schedule allows for less disruption to clinical practice and continuing education credits (CME/CNE/SOCRA CE) apply.
Please note, this workshop is intended to be interactive. Video attendance is strongly encouraged. Once you register, you will be able to install and test the appropriate software to ensure your audio and video will work properly during the program. Please be sure to give yourself time to address any technical issues that might arise. Please contact us with any questions or concerns at education@socra.org.
Dates:
April 28th, 2026 & April 29th, 2026
Time:
8:30am to 4:00 pm ET*
*All times in Eastern Standard Time Zone
Registration Fees:
- Member Fee – $600
- Non-Member Fee – $675*
Continuing Education Credit Hours:
SOCRA designates this educational activity for a maximum of 11.75 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 11.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Accreditation Statements:
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.
SOCRA Course Series: 700
Agenda:
Day One: Tuesday
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
Day Two: Wednesday
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
Faculty Bios:
Gabrielle Swain
Gabrielle Swain is a BIMO FDA Investigator based out of the Philadelphia District Office. She is experienced in a wide range of BIMO establishment types, especially with corporate headquarters (Sponsors/PADEs) and institutional review boards. Investigator Swain has identified regulatory violations in both domestic and international inspections and worked with various regulatory groups and center collaborators.
Investigator Swain will be participating in the Knock Knock – The FDA Inspection, Quality by Design, and Improving Informed Consent presentations. Prior to joining FDA in 2019, Investigator Swain was involved in viral vector manufacturing for industry.
Mishelle Harriger
Mishelle L. Harriger, Division Director (acting) Office of Inspections and Investigations, Office of Bioresearch Monitoring Inspectorate, Division 1 (Northeast). Ms. Harriger has been with the Food and Drug Administration since 2000. She has served the agency as an investigator, branch chief and recently as the acting division director for the Northeast. She has experience in navigating the regulatory environment for various FDA commodities and program areas and has been focused on bioresearch monitoring since 2017. Providing coverage for an area that is home to large medical institutions and medical product development companies, has presented Ms. Harriger with a wide variety of experience related to clinical research from the regulatory perspective.
D'Arbra Blankenship, MS
D’Arbra Blankenship, MS, is an OBMI Investigator committed to ensuring public safety through comprehensive inspections of study date integrity and efficacy. She is in her fifth year with the FDA after a 17-year career in academic research in non-clinical drug and medical device development from the preliminary phase into clinical human trials. D’Arbra has more than 13 publications covering topics in neuroscience, physics, and infectious disease. She holds two patents.
Kathryn Suttling
Kathryn Suttling is a BIMO FDA Investigator Specialist based in Cincinnati, Ohio, with extensive inspection experience both domestically and internationally, having conducted inspections in more than 10 countries. Since joining the FDA as a college intern, she has built her career at the agency, conducting a diverse range of inspections across clinical research settings. At SOCRA, Investigator Suttling will present on regulatory requirements for Institutional Review Boards (IRBs) and Clinical Investigators, as well as the critical role of the Clinical Research Pharmacist in ensuring compliance and patient safety.
Meredith Miller
Meredith Miller is a BIMO FDA Investigator based out of the Boston office. She is experienced in all the types of inspections BIMO conducts, especially the less common ones such as Institutional Review Boards and Risk Evaluation and Mitigation Strategies. Investigator Miller has identified regulatory violations at all levels of clinical trials, from private practice clinical investigators to multinational sponsors.
Investigator Miller will be presenting on FDA conduct of clinical investigator inspections and informed consent regulations. Before joining FDA, Meredith worked on a lab benchtop optimizing the manufacturing of chemicals used in COVID PCR testing.
Alyssa Gateman, MPH, CCRP
Alyssa Gateman currently serves as the Executive Director of the Yale Cancer Center Clinical Trials Office. Since joining Yale in July 2014, she has also held the role of Senior Associate Director of Quality Assurance and Research Regulatory Initiatives at the Yale Center for Clinical Investigation. Prior to her time at Yale, Ms. Gateman was Director of the Quality Assurance Office for Clinical Trials at Dana-Farber/Harvard Cancer Center.
Ms. Gateman is deeply committed to advancing the clinical research workforce through education and mentorship. In addition to her long-standing involvement with SOCRA, she serves as Adjunct Faculty at Southern Connecticut State University, where she teaches Good Clinical Practices and Clinical Trial Administration as part of the Healthcare Studies undergraduate program. A dedicated SOCRA member, she will celebrate 23 years of membership and 20 years of certification in 2026. She is a former SOCRA Board member, frequent presenter for SOCRA and currently serves as the inaugural President of the Connecticut SOCRA Chapter.
Outside of work, Ms. Gateman enjoys supporting the Yale Junior Bulldogs hockey team as a coach’s wife and goalie mom, and spending time with her golden retriever, Biscuit.
Jessica Rowe, MA, MS, CCRP, CIP
Jessica Rowe, MA, MS, CCRP, CIP, is the Quality and Education Director for the Yale Cancer Center Clinical Trials Office. Previously, she served as the Associate Director for Regulatory, Compliance, and Quality at the Yale Center for Clinical Investigation (YCCI) and the Yale Human Research Protection Program (HRPP). Before her tenure at Yale, Jessica was the HRPP Director for WellSpan Health, where she managed a comprehensive human research protection program.
Jessica has an extensive 13-year background at the University of Maryland, Baltimore (UMB), where she held multiple roles in the research field and was an active member of several research review committees. She continues to contribute as an IRB member for both UMB and Yale, and she chairs the Southern Pennsylvania SOCRA Chapter while also serving as the Immediate Past President of SOCRA.
Jessica is an adjunct instructor at the University of Maryland, Baltimore Graduate School, teaching courses in research compliance and administration. She is a recognized faculty member in several SOCRA workshops, including Quality Management and the GCP Prep Course.
With extensive experience in human subject research compliance, IRB, quality, clinical trial management, education, and training, Jessica is a Certified Clinical Research Professional (CCRP) and a certified IRB Professional (CIP). She also holds a graduate certificate in Research Ethics from the University of Maryland, Baltimore. Her passion lies in human subject protections, bioethics, quality, and compliance.