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Adverse Drug Reaction (ADR) - 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 adverse d...

The _________ has developed the Declaration of Helsinki (DoH): - 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 resear...

ADR - Answer- Adverse Drug Reaction Audit - Answer- Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Answer- Confirmation audit took place Audit Report - Answer- Written Evaluation - not regularly made available...

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - Answer- 50% To be eligible for a trial, the subjects must have liver function tests no greater than two ti...

1. A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliance is he? A. 50% B. 64% C. 78% D. 100% - Answer- 1. Answer: A - Math Calculation: 120 = # dispensed, 120-88 (# r...

What is ICH E2A? - Answer- Clinical Safety Data Management -Definitions and Standards for Expedited Reporting -This document gives standard definitions and terminology for key aspects of clinical safety reporting. -It also gives guidance on mechanisms for handling expedited (rapid) reporting of...

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. - Answer- True Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater i...

c) Is not necessarily causally related to drug - 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 - Answer- An adverse event is one which a) Is an unfavorable...

Who is considered "vulnerable"? - Answer- 1. prisoners 2. med/nursing students 3. military 4. people in nursing homes 5. impoverished/unemployed/homeless 6. minors 7. ethnic minorities 8. people with incurable/terminal illnesses A participant develops colon cancer (unrelated to study) an...

Regulations - Answer- - are issued by regulatory authorities such as the FDA, or European Medicines Agency [EMA] -applicable only in the country or countries within the jurisdiction of these authorities (e.g. FDA = USA, EMA = Europe) The 3 primary ICH regions - Answer- Japan, USA, EU Why di...

Adverse Drug Reaction (ADR) - 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 adverse d...