It is important to distinguish the trial protocol from the Study Operations Manual, the former is the scientific statement of the trials aims and methods; the latter is a very detailed description of all the study processes that deliver the trial. The Study Operations Manual is intended to grow organically as the study progresses, documenting problems and their solutions, and also ensuring their consistent implementation across centres in a trial.
Other essential documentation includes the trial master file and the sites master file.
The trial master file includes all documentation related to the trial such as the protocol, research ethics committee approval, regulatory approval and sponsorship agreement.
The site master file includes all documentation related to the trial, relevant to the individual sites. It is the responsibility of the central coordinating office to provide the sites with any updated documents and for the sites to keep the file up to date.
Example of all documentation to be included in the trial master file form the Centre for Health Care Randomised Trials, CHART, Health Services Research Unit, University of Aberdeen.