Date and version number
Protocols are normally dated and given ‘version’ numbers. This is a way of ensuring that the most current protocol is in circulation and any changes made are transparent.
There are three main types of investigators in research studies. The ‘chief investigator’ is the person in charge of the whole project who is ultimately responsible for its design and running. If the study has multiple locations, there may also be ‘principal investigators’ who take local responsibility and report back to the chief investigator (although sometimes ‘chief’ and ‘principal’ investigator are used interchangeably). Other people involved in the study in positions of responsibility are called ‘co-investigators’. There may also be research assistants, project managers, consultants, healthcare professionals and students involved.
The sponsor is the individual or organization taking ultimate responsibility for the whole project, including initiating, managing, and financing it (or sourcing the funding). This may well be the research and development department within a hospital or other institution, or the employer of the chief investigator or an educational institution or the funder themselves. Sometimes there may be more than one sponsor, but in this case a ‘lead sponsor’ should be nominated.