Writing a GCP Compliant Protocol

Statutory Instrument 2004/1031 – the Medicines for Human Use (Clinical Trials) Regulations 2004 transposed the European Union Directive 2001/20/EC for Clinical Trials into UK law effective from the 1st May 2004. The original UK regulations were amended in August 2006 to incorporate the EU Good Clinical Practice Directive (2005/28/EC) as Statutory Instrument 2006/1928.

This SOP describes the format for writing a research protocol to Good Clinical Practice (GCP) as required by the Regulations. The primary focus of this SOP is CTIMPs that fall within 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 following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

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 (6.5Mb)

Related Documentation