ACRP CCRC Bundle Set

What are expected or possible consequences of over-estimation of recruitment potential? Answer - 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 and will be...

What are expected or possible consequences of over-estimation of recruitment potential? Answer - 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 and will be...

Clinical Trial Answer process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome Answer Clinical event, measurable indicator, subject reported response...

What is an Adverse Event (AE) ? Answer Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) What is an Adverse Drug Reaction (ADR)? Answe...

What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? Answer To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects. What guideline's purpose is to define G...

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 research ...

CCRC Exam - Section 1 questions with correct answers

ICH E6 (R2) Answer ICH guideline that is known as GCP guideline 21 CFR 312.3 Answer Individual who actually conducts a clinical investigation. In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. Phase I Answer Clinical tr...

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% 1. Answer: A - Math Calculation: 120 = # dispensed, 120-88 (...

This phase determines therapeutic benefit and is usually done in a larger, specific population. Answer Phase 3 The purpose of source documentation is Answer To verify that the date in case report forms are consistent with that in the source documents (ICH E6 sec 8.3.13) What is the minimum nu...

What is pharmacokinetics? Answer Study of a drug's absorption, distribution, metabolism, and excretion. What is pharmacodynamics? Answer Study of effects of drugs on the body and their mechanism of action. What is pharmacology? Answer Study of uses, effects, and modes of action of drugs Wh...