An Investigator should be an appropriately qualified person legally allowed to practice medicine or dentistry, trained in clinical research in the area of investigation, familiar with the background of the study and known to have high ethical and professional standards. The Investigator selects, treats and takes medical care of the subjects enrolled in a trial. He or she usually heads a team of clinical assistants, nurses, and laboratory personnel. In agreeing to conduct a trial under GCP, Investigators take upon themselves considerable procedural responsibilities for the conduct of the trial, the care of the trial subjects and the recording of the data.The clinician in charge of the trial is known as the 'Principal Investigator' and is responsible for the practical performance of a trial. Other authorized clinicians are known as 'Co-Investigators' or 'Sub-Investigators', the latter normally reporting in to the Principal Investigator as part of a clinical team. The more complex the trial procedures, e.g. in oncology studies, the more likely it is to have Sub-Investigators. In multi-center trials, there may be one Principal Investigator at each center and a coordinating committee to manage the trial as a whole.GCP procedures confer upon Investigators considerable responsibilities for the conduct of a trial and the recording of data, whilst they ensure the protection and the rights of subjects.
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