Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, recording, analysis, and reporting of research that involves human participants. Ultimately GCP is in place to protect the rights, safety and welfare of humans participating in research, and to assure the quality, reliability, and integrity of data collected. All members of the research team (investigators, sponsors, and research ethics boards) are required to follow GCP.
All Health Canada-regulated clinical trials require the maintenance of essential documents. It’s strongly recommended that all non-regulated research studies maintain these documents to comply with GCP guidelines. These documents are generally filed in the Trial Master File (sponsor), or the site regulatory file (site level). To assist you, included in the following list of required documents are templates that can be used/modified for investigator-initiated studies and sponsored studies as well.
A list of Essential Documents and their purpose can be accessed here.