This is the planning stage of a research study before the study formally starts.
It is expected that many documents will be generated during the initiation and set-up stage of a research study and these documents should be kept safely and securely by the researcher in a master file. Collectively, these documents will be known as Essential Documents and will help the researcher to demonstrate during an audit or inspection that their study adheres to the Principles of Good Clinical Practice; this is extremely important when conducting NHS research.