Can RN Perform Physical Exams

Question 1:

I have encountered debate on whether a RN can perform Physical Exams (not physical assessments, which is what they do all the time). What is FDAs expectation when Physical Exams are required in a protocol, but the protocol does not stipulate at minimum?

I would assume if a Sate Nursing Board identifies that this is allowed within a RN license, that this would be acceptable. And if a Sate Nursing Board does not allow, then clearly this would not be acceptable.

Does the FDA have a minimum expectation of who should perform Physical Exams within a clinical trial setting?

Answer 1:

Thank you for your inquiry regarding who can perform physical examinations in clinical studies.

FDA does not regulate the practice of medicine and therefore specifics in this regard are not included in pertinent regulations. It is expected that the requirements of the most local jurisdiction - which is usually the state - will determine what is done at a particular site with regard to what is usual for the practice of medicine. If the state allows for a licensed registered nurse to perform physical examinations, then it would be acceptable to FDA. However, if the study sponsor specifically states in the protocol who can and cannot perform any study-related function, that would supersede whatever the local requirements are, as long as the protocol requirement is at least as stringent as that allowed by the state in question.

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