Documentation, Audits, Study Closure
Facts on Research Documentation, Audits and Study Closures
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Topics of this game:
- What does the "C" in ALCOA stand for?
- What is not required for every entry into a case report form?
- Which is a reason for a sponsor audit
- Which does not happen prior to an FDA audit?
- What does the "L" in ALCOA stand for?
- Name the two types of FDA audits
- How many hours notice of an audit does the FDA give a site?
- What form is issued if regulatory responsibilities were not met during an audit?
- True or False, Concomitant medications are audited
- The EIR classification that requires no action is?
- True or False, a consequence of a poor audit is delay of NDA
- The most common reason for study closure is?
- How many years after study closure must records be kept after NDA approval?
- If NDA not filed or disapproved how long must records be kept after closure?
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