Good Clinical Practice Already Passed

When the FDA conducts an inspection, the inspectors will: A) Issue a warning letter. B) Recommend protocol changes. C) Review regulatory records. D) Determine if the Assurance should be restricted. {Ans: C}Class __________ devices are the lowest risk devices and are governed by general controls (that is, Establishment Registration, Device Listing, Compliance with Good Manufacturing Practice [GMP] regulation, labeling, and Medical Device Reporting [MDR] of death or serious injuries). {Ans: I}The two (2) important goals of ICH E6 are to assure that: {Ans: The rights, well-being, and confidentiality of trial subjects are protected and Trial data are credible}If an investigator sees study subjects at more than one site, should the investigator list all sites on the 1572? {Ans: Yes. The names and addresses of each of the study sites should be identified in Section #3. However, if the protocol specifies that the investigative product can be administered at a subject's home (for example, the protocol allows for daily injections to be administered by a registered nurse in the subject's home), the subjects' home addresses do not have to be listed on the 1572. Study records should reflect that the test article was administered at subjects' homes