Writing a GCP Compliant Protocol
The format for writing a research protocol in accordance with Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trials) Regulations.
Writing a GCP Compliant Protocol
A protocol is the legal document that defines the study plan for a clinical trial. It sets out the study objectives, participant population, schedule of tests and procedures, treatments, and study duration.
Protocols are designed to protect participant safety while ensuring the research questions can be answered. This SOP applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations.
Use of the King’s Health Partners Clinical Trials Office protocol template is recommended for CTIMPs and should be adapted for the trial.