Guidelines to writing a clinical protocol

Writing a clinical protocol initially appears to be a daunting task. By taking advantage of templates that are available electronically, however, you can draft a protocol relatively easily. Protocol templates for phase I and II clinical trials are available on a website of the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI) [http://ctep.cancer.gov/guidelines/templates.html]. These templates are used commonly by investigators developing studies through the Gynecologic Oncology Group or NCI-designated Cancer Centers. The major goal in writing a protocol must be clarity. You want the doctors, nurses, and pharmacists who read your protocol to understand exactly what to do at each step of the process.