In the case of a CTIMP:
- In relation to a clinical trial conducted at a single trial site, the Investigator for that site; or
- In relation to a clinical trial conducted at more than one trial site, the authorised health professional, whether or not he is an Investigator at any particular site, who takes primary responsibility for the conduct of the trial.
For research other than CTIMPs:
The person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design conduct and reporting of the study whether or not that person is an Investigator at any particular site.