Abstract
Introduction: In September 2021, the National Cancer Institute (NCI) expanded the ability for advanced practice providers (APP) to practice more autonomously by being able to write orders for research-related anti-cancer therapy. Objectives: The goal was to align with NCI guidance to permit APPs to independently write non-Cycle 1 Day 1 study agent orders. Methods: An academic institution created a process to comply with the NCI’s memorandum. Health-system policy was updated to reflect this new capability. A tracking system was established to monitor NCI’s Registration and Credentialing Roster (RCR) expiration dates. An audit process was created to verify alignment between signed electronic research-related anti-cancer therapy orders and Delegation of Tasks Logs. Results: To date, no adverse comments about APPs’ abilities to sign anti-cancer trial orders have been received from organizations that accredit or support clinical trials. In addition, no APPs have lost the ability to sign anti-cancer therapy orders because they failed to renew their RCR within the expiration period. To facilitate this capability in a timely manner, a research-specific onboarding experience was created. Conclusion: APPs may safely write anti-cancer treatment orders for patients enrolled in clinical trials. Additionally, such privilege may contribute to the enhanced participation of APPs through research.
References
Advanced Practitioner Society for Hematology and Oncology. (2025). APSHO cancer therapy prescribing course. https://apacademy.apsho.org/CTPC-Course
Braun-Inglis, C., Boehmer, L. M., Zitella, L. J., Hoffner, B., Shvetsov, Y. B., Berenberg, J. L.,...Benson, A. B. 3rd. (2022). Role of oncology advanced practitioners to enhance clinical research. Journal of the Advanced Practitioner in Oncology, 13(2), 107–119. https://doi.org/10.6004/jadpro.2022.13.2.2
Braun-Inglis, C. M., Hoffner, B., Kottschade, L., Pierce, E., & Kurtin, S. (2023). Role of the advanced practitioner in clinical research. Journal of the Advanced Practitioner in Oncology, 14(3), 43–48. https://doi.org/10.6004/jadpro.2023.14.7.14
Bruinooge, S. S., Pickard, T. A., Vogel, W., Hanley, A., Schenkel, C., Garrett-Mayer, E., & Williams, S. F. (2018). Understanding the role of advanced practice providers in oncology in the United States. Journal of Oncology Practice, 14(9), 518–532. https://doi.org/10.1200/JOP.18.00181
Collaborative Institutional Training Initiative. (n.d.). CITI program. https://about.citiprogram.org/
National Cancer Institute. (n.d.). CTEP Resources for Clinical Trials in NCI Networks. https://dctd.cancer.gov/research/ctep-trials
The Cancer Therapy Evaluation Program of the Division of Cancer Treatment and Diagnosis, National Cancer Institute. (2025). Guidance and update on advanced practice providers writing study agent orders on clinical trials supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program. https://ctep.cancer.gov/investigatorresources/docs/Memorandum-Study-Agent-Ordering-Update-Sept.07.2021-FINAL.pdf