In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment.
Formal protocols typically require approval by one or more individuals—including for example a laboratory directory, study director,[11] and/or independent ethics committee[12]: 12 —before they are implemented for general use.
[14] In a clinical trial, the protocol is carefully designed to safeguard the health 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, medications, and dosages; and the length of the study.
While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.
[20] An experimenter may have latitude defining procedures for blinding and controls but may be required to justify those choices if the results are published or submitted to a regulatory agency.