ACRP Tests Compilation Bundle

Adverse Drug Reaction (ADR) Correct Answer: In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered ad...

ADR Correct Answer: Adverse Drug Reaction Audit Correct Answer: Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate Correct Answer: Confirmation audit took place Audit Report Correct Answer: Written Evaluation - ...

The _________ has developed the Declaration of Helsinki (DoH): Correct Answer: World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medical...

1571 ` Correct Answer: IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 Correct Answer: Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP ...

c) Is not necessarily causally related to drug Correct Answer: An adverse event is defined as one which a) Results in hospitalization b) Causes a disability c) Is not necessarily causally related to drug d) Is life threatening d) a and b Correct Answer: An adverse event is one which a) Is ...

Human Pharmacology Study -Assess Tolerance -Define/Describe pharmacokinetics and pharmacodynamics -explore drug metabolism and drug interactions -estimate activity Human Pharmacology Study Examples: -dose tolerance studies -single and multiple does pharmacokinetics and pharmaco...

CRA ACRP Practice Exam Questions w/ explanation