This SOP describes the format for writing a research protocol in accordance with Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trials) Regulations. The primary focus of this SOP are CTIMPs, as they are governed by the Regulations. However, it is also relevant for any project involving humans, their tissue and/or data.
A research protocol is the legal document that outlines the study plan for a clinical trial. The plan must be carefully designed to safeguard the health and safety of the participants, as well as answer specific research questions. A protocol describes who the participants are in the study; the schedule of tests, procedures, medications, and dosages; and the length of the study. While enrolled in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment - in accordance with the protocol.
It is recommended that the related Protocol Template (section 5.1) is used for clinical trials of Investigational Medicinal Products (CTIMPs). The procedures described in this SOP and in the protocol template focus on CTIMPs - however, both can be adapted for all clinical research. For non-CTIMP research studies non-applicable sections may be deleted.
SOP: Writing a GCP Compliant Protocol (325Kb)
GCP Compliant Protocol Template V9.1 (1.2Mb)
