The chair and vice-chair, with consultation from other Committee members as they deem necessary, review and administratively approve this type of RDRC application, which involves the use of FDA-approved radiopharmaceuticals used to perform standard diagnostic nuclear medicine tests (labeled indication) that are generally incidental to the objectives of the research study. Examples include the use of Tc-99m red cells for radionuclide ventriculography in a trial of cardiotoxic drug or F-18 fluorodeoxyglucose for response assessment in a cancer chemotherapy trial. These administrative approvals are reviewed by the full Committee at the meeting immediately following the administrative approval. At the discretion of the chair, a protocol eligible for administrative review may be sent to the full Committee for formal review and approval.
Please use the application form, “Application For Use of Standard Nuclear Medicine Procedures In Research Investigations Involving Human Subjects” for an administrative review.