New York State


Investigator-Initiated Device Studies: Key Concepts and Unique Challenges

Abby Statler, PhD, MPH, MA, CCRP
Director of Research Quality and Safety, Dartmouth Health

June 17, 2024, 12:00 – 1:00 p.m. EST


Register in advance for this meeting:

After registering, you will receive a confirmation email containing information about joining the meeting.


Objective: This presentation will focus on device studies that are sponsored by a single investigator. Navigating the regulatory landscape, from both the sponsor and investigator role, requires a specific level of expertise. Appreciating the operational fundamentals while anticipating potential barriers are essential to finding success in this area. This presentation will focus on these areas, providing educational content that aims to enhance the audience’s device skillset within the context of investigator-initiated trials.

Speaker Bio: Dr. Statler is currently the Director of Research Quality and Safety at Dartmouth Health, in this role she oversees the research compliance program across the health system, focusing on leading initiatives that aim to protect the rights, safety, and welfare of research participants. Prior to joining the Office of Research Operations at Dartmouth Health Abby spent 10+ years developing, implementing, and maintaining the Cleveland Clinic Cancer Institute’s Quality Assurance Department. SOCRA is also an integral part of Abby’s career; she served as President (2021-2022) and currently Chairs the SOCRA Quality Management Conference. She also has her PhD in Population and Quantitative Health Sciences; her dissertation focused on providing empirical evidence to support the modernization of eligibility criteria for hematologic malignancy clinical trials.


The Society of Clinical Research Associates (SOCRA - accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1 hour of continuing education hours. *When registering, note Certificate of Attendance Need (General or SOCRA).

Chapter Chairpersons:

Kathi Durdon, CCRP
Phone: 315 464 9290

Kurits Ahart, CCRP
Phone: 607 201 3942

Kylie Sands  , CCRP
315 261 6312

Rebecca Quilty-Koval