ACRP CCRC exam (A+ GRADED)

What are expected or possible consequences of over-estimation of recruitment potential? correct answers - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe an...

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

The _________ has developed the Declaration of Helsinki (DoH): correct answers 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 ...

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? correct answers 50% To be eligible for a trial, the subjects must have liver function tests no greater than ...

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

Adverse Drug Reaction (ADR) correct answers All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at dose...