Who is responsible for making the initial risk determination for device being used in a study?7. Who decides whether a device study is SR or NSR? Sponsors are responsible for making the initial risk determination and presenting it to the IRB.
Which is a responsibility of a sponsor investigator conducting an IND study quizlet?Responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the ...
Which of the following are the sponsors responsibilities?Generally, a sponsor is responsible for: Selecting the investigator(s) Providing investigator(s) with the necessary information to conduct the clinical trial. Ensuring proper monitoring of the clinical study.
Who is responsible for control of investigational drug?312.61 Control of the investigational drug. An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator.
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