Investigator is a person who carries out clinical research, while sponsor is a person who initiates it. The sponsor is responsible for collecting and evaluating the results obtained from the investigator and must submit annual reports to the FDA. The investigator must inform the IRB of all changes in research activity and of all unforeseen problems that pose a risk to humans or others. A contract research organization can assume some or all of the obligations of the sponsor, but the principal investigator is still responsible for the investigation.
Sponsors are required by law to select qualified people to carry out clinical trials. The notification should explain that an investigator who is ineligible to receive test items will not be able to conduct any clinical research that supports a request for research or marketing permission for products regulated by the FDA. If the appropriate Center does not accept an explanation, the investigator will have the opportunity to hold a regulatory hearing under part 16 of this chapter. An investigator who has been determined to be ineligible may be reinstated when the Commissioner determines that adequate assurances have been provided.
Following good clinical practice standards for clinical research will result in quality data collection and facilitate the analysis and publication process. To determine if IP oversight is adequate, the FDA evaluates study personnel qualifications, training, participation, and supervision of third parties and contracted research organizations. A private investigator can outsource research tasks to contract research organizations. For phase 2 or 3 investigations, a summary of the study protocol should include an approximation of the number of subjects, clinical uses, characteristics of subjects, type of clinical observations and laboratory tests, estimated duration of study, and case report forms.
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