cra ii interview questions shared by candidates
When you are monitoring subject data, how would you relate it to the items in a regulatory binder?
For key and important procedures, such as physical exams, AE assessments, I would look through the regulatory binder to ensure that the individuals performing the assessments are listed in the delegation log, training is documented, and appropriate documents (ex: medical license, CVs, FDFs) are appropriately filed and up-to-date.
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