Disambiguation: Protocol.
A document, written prospectively before recruiting participants into a trial, which records the general rules and intended methods of conducting, analysing, and reporting the trial. Many also include a statistical analysis plan. Trial protocols are tens to hundreds of pages in length. A protocol may be required by the research ethics board, a data and safety monitoring board, or a funding body. Any planned or actual changes from the original written protocol in the conduct should be documented with formal protocol amendments.
Example: GSK Paroxetine Study 329 Protocol (source)
