Protocol (natural Sciences) - Overview

Overview

Formal protocols are the general rule in fields of applied science, such as environmental and medical studies that require the coordinated, standardized work of many participants. Such predefined protocols are an essential component of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. Protocols written for use by a specific laboratory may incorporate or reference standard operating procedures (SOP) governing general practices required by the laboratory. A protocol may also reference applicable laws and regulations that are applicable to the procedures described. Formal protocols typically require approval by a laboratory official before they are implemented for general use.

Manufacturing protocols are required by current good manufacturing practice (cGMP) for manufacture of foods, pharmaceuticals, and medical devices.

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. Since 1996, clinical trials conducted are widely expected to conform to and report the information called for the in the CONSORT Statement, which provides a framework for designing and reporting protocols. Though tailored to health and medicine, ideas in the CONSORT statement are broadly applicable other fields where experimental research is used. Clearly defined protocols are also required by research funded by the National Institutes of Health.