NRG Oncology PSC 2026 Summer Meeting Wrap-Up

08/12/2026

Written by Belinda Buehl, BS, Regulatory Coordinator with the University of Wisconsin Department of Radiation Medicine

On behalf of the Protocol Support Committee (PSC), we would like to thank everyone who attended the NRG Oncology Semi-Annual Meeting in Denver, Colorado. The PSC Nurse/CRA Continuing Education Session, held Thursday morning, welcomed 307 attendees, including 109 in person and 198 virtually.

The session began with a warm welcome from Cindy Licavoli, RN, BSN, MHA, Chair of the Protocol Support Committee. Cindy reviewed how attendees could access the recording and presentation slides from the virtual session and shared information about the PSC Mentorship Program. She also celebrated the upcoming one-year anniversary of the Discuss With Us program, highlighting its success with more than 10 Zoom sessions held to date. Cindy concluded by announcing the next Discuss With Us session, scheduled for August 19, which will focus on “Recruitment Recipe: Ingredients for Trial Success.”

Jackie Ludwig, RN, BSN, CCRP, and PSC Education and Training Vice Chair, then shared details about the PSC Discuss With Us Live Lunch and Learn session, which took place during the noon hour. Attendees were provided with boxed lunches while participating in an hour of education and discussion, followed immediately by interactive roundtable sessions.

A special thank you was extended to Alison Ivey, CTN Vice Chair, for providing IT support during the PSC morning education sessions!

Sharon Hartson Stine, NRG Oncology Executive Director, provided organizational updates, including recognition of NRG Oncology’s corporate supporters and collaborative partnerships that helped support the conference. Sharon also shared an update on the NRG Oncology grant, noting that although the application received a perfect score last year, the Notice of Award (NOA) had not been awarded at the time of the meeting. Since then, the NOA has been officially awarded. She reviewed funding updates for the NCORP program and the Biospecimen Bank as well. Sharon also discussed site membership requirements for international members, New Member Institution Agreements, and policy updates related to the Code of Conduct, meeting photography and videography, and ancillary projects. Looking ahead, Sharon announced the development of a new Advanced Practice Providers (APP) Subcommittee and encouraged attendees to watch for upcoming application opportunities. She concluded by reviewing committee member application and rotation requirements and recognizing the travel award recipients, as well as highlighting the NRG Oncology Podcast.

Sara McCartney, Senior Adverse Event Specialist, provided updates on adverse event (AE) reporting. Key topics included streamlined clinical trials (SCTs), expedited reporting challenges and frequently asked questions, and a progress update on adverse events start and end date reporting.

The overall goal is to make clinical trials more streamlined and reduce the reporting burden while maintaining patient safety. Two studies, NRG-GI012 and NRG-GU015, were highlighted as SCTs. The streamlined reporting approach is intended to simplify reporting requirements, when appropriate, while enabling real-time review of events that have a direct impact on study conduct and participant safety.

Mary Jo Antonelli, MBA MHA CCRP, Director of NRG Oncology Quality Assurance, provided an overview of the purpose of the NRG Oncology audit program and the key components of an audit, including what is reviewed, common deficiency trends, important considerations, corrective and preventative action (CAPA) development, frequently asked questions, and available resources. She highlighted common regulatory deficiencies, including unapproved changes to local informed consents (such as boilerplate revisions), HIPAA (Health Insurance Portability and Accountability Act)-related issues, failure to maintain delegation of task log (DTL) approvals, and study-related pharmacy responsibilities that were not appropriately assigned on the DTL. Additional findings included investigational drug accountability issues, such as failure to return investigational product according to protocol and inaccurate accountability logs. Mary Jo also noted an increase in informed consent deficiencies, including improperly executed consent documentation processes, missing signatures or signatures on incorrect lines, unanswered consent questions, and improperly executed re-consent documentation processes. Additional audit findings included participants who did not meet eligibility criteria, treatment administration that was inconsistent with or inadequately documented according to the protocol, dose modifications that were not performed per protocol, and missing or inaccurate oral drug accountability records.

Danielle M. Enserro, PhD, presented “Power of Effective Data Management: Bridging the Gap Between Data Collection and Statistical Analysis for Clinical Trial Success.” The session focused on defining key statistical concepts in oncology clinical trials, highlighting the critical role of data management in ensuring accurate and meaningful statistical analysis, and demonstrating how high-quality data collection directly influences trial outcomes. A central question posed during the presentation was “What makes a trial successful?”  The answer comes down to a trial’s ability to generate accurate, reliable, meaningful, and actionable evidence. Danielle emphasized that strong data management practices are fundamental to achieving this goal and are essential to the overall success of every clinical trial.

Cindy Licavoli, RN, BSN, MHA, Chair of PSC, presented an overview of the NRG Oncology Protocol Support Committee (PSC). She reviewed the purpose, primary function, and structure of the NRG Oncology PSC, introduced PSC leadership, discussed the six PSC subcommittees, and highlighted PSC liaisons. Cindy provided PSC Discuss with Us programming updates and reviewed NRG Oncology PSC training modules available in CTSU Compliance, Learning and SOP Solutions (CLASS). PSC poster presentations are planned for the winter meeting. Links are available on the NRG Oncology website, together with a strong list of future CLASS topics.

We listened to a pre-recorded session on “CTSU Updates” by Rachel Albershardt, MS, CRP. The modernization effort is currently in Phase 2 of development. Please watch for additional updates in the coming months. Examples of progress to date include simplified user view, user-specific metrics, revamped quick links, and streamlined support.

Jeffrey Yap, PhD, and Helosia Soares, MD, PhD, discussed “Theranostics 101.”  Theranostics is the combination of therapeutics and diagnostics. Jeffrey provided an overview of the history of the first theranostics, reviewed diagnostic and therapeutic isotopes, and highlighted the critical infrastructure needed to conduct theranostic trials. Dr. Soares addressed the current clinical use of radioligand therapy and explained why theranostics is valuable. Radioligands serve dual roles in both diagnosis and treatment. The three most common applications today are the treatment of thyroid cancer, certain neuroendocrine tumors, and PSMA-positive metastatic prostate cancer. Specific approaches discussed included radioisotopes, DOTATATE, and PSMA-targeted radioligand therapy (RLT).

Thomas George, MD, FACP, FASCO, NRG GI Committee Co-Chair, discussed “Liquid Biopsies for Cancer: Pearls and Pitfalls.”  The goal of the session was to help attendees better appreciate the role and the limitations of circulating tumor DNA (ctDNA) in clinical research and cancer care. Dr. George emphasized that correct sample collection, processing, and storage are critical steps. CtDNA remains a tool still under development.

The PSC hosted its Discuss With Us Live Lunch and Learn, drawing ninety-seven in-person attendees. Cancer survivor, Kimberly Williams, and a cancer caregiver, Lisa Lenrow, led the session titled “Patient Advocacy: Bridging the Gap between Researchers and Patients.”  Pointed questions explored trust and distrust, patient experiences versus provider perspectives, myths versus reality, and how providers’ assumptions about what the patient and caregivers know (or do not know) shape care. Discussion also addressed the myth that caregivers know more than they do, and what the presenters wish their doctors and nurses better understood. The conversation was meaningful and illuminating. It highlighted shortcomings that can arise in care delivery and offered practical insight into how we can better support patients and caregivers.

Last but certainly not least, the Thursday afternoon roundtable discussions featured eighteen educational topics and generated an impressive 374 table visits. Discussion topics included Organizing Your Workday, Study Startup, Site Administration, Onboarding New Coordinators, Adverse Event Reporting, Quality Assurance, and disease-specific protocol reviews.

The roundtables received overwhelmingly positive feedback. Attendees appreciated the opportunity to connect with colleagues from other sites, exchange best practices, and learn from one another’s experiences. Participants also commented on the enthusiasm and collaborative spirit of the discussions, and expressed appreciation for the important work performed by research professionals. A sincere thank you to the PSC members who helped coordinate the sessions and served as roundtable facilitators. Your dedication and expertise made this another successful, engaging, and valuable learning experience.

A heartfelt thank you to NRG Oncology for its continued commitment to offering a virtual option for our continuing education sessions, making these valuable educational opportunities accessible to even more members.

Special thanks also to our outstanding PSC Education and Training subcommittee leaders, Cindy Licavoli, Chair, and Vice Chairs Marissa Weiss and Jacqueline Ludwig for their dedication, leadership, and efforts in delivering this engaging and successful educational programming.