Quality & Safety

Clinical Trial Amendments: Development of a Process for Consistent Implementation

Gretchen A. McNally

Amanda K. Hrnicek

Hallie Barr

clinical trials, amendment, implementation, process, program development
CJON 2017, 21(5), 627-628. DOI: 10.1188/17.CJON.627-628

Clinical trials are responsible for the advancements made in cancer care. An interdepartmental work group at a major academic cancer hospital developed a process for the consistent communication and implementation of clinical trial amendments. This process ensures improved patient safety, as well as high-quality research.


  • Clinical trials lead to advancements in cancer care, including improvements in cancer-related morbidity and mortality.
  • Standardizing communication and developing a process for applying treatment plan changes improves patient safety and  decreases errors.  
  • The process developed and successfully implemented at a large academic cancer center ensures accurate and timely implementation of clinical trial amendments.
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