A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?
In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:
A protocol amendment is needed to collect additional data from a participant’s medical record. When can the research team begin collecting the additional data?
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