Protocol Document

A protocol is a study plan upon which clinical trials are based. The plan is carefully designed to safeguard the health and safety of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, treatments, and dosages; and the length of the study.

NCCAM requires that study investigators submit a final protocol document for all funded clinical projects. The protocol must be submitted to the NCCAM Program Director prior to study implementation. (Note: If the clinical study is being conducted at an institution that has a Clinical and Translational Science Award (CTSA), study investigators may be required to generate a protocol specified by their CTSA.)

The clinical study protocol templates below are examples that are intended to provide guidance in writing and developing clinical research protocols that are in compliance with regulatory and other requirements. (Note: The templates include instructions, which need to be replaced by study-specific information.) The templates can be downloaded as MS Word files for adaptation by the study investigator:

• Clinical Study Protocol Template
  • Word version [80KB Word file]
  • PDF version [342KB PDF] (not editable)