ACRP CCRA (with 100% Verified Solutions) .

Phase I Trial AKA correct answers Human Pharmacology Phase I Trial correct answers -Assess tolerance. -Define/describe PK and PD. -Explore drug metabolism and drug interactions, estimate activity. -Done in healthy volunteers.10 -100 people Phase II Trial AKA correct answers Therapeutic E...

Who is considered "vulnerable"? correct answers 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 stu...

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...

Adverse Drug Reaction (ADR) correct answers 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 adv...

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 ...

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 ...

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 ...

ICH E6 (R2) correct answers ICH guideline that is known as GCP guideline 21 CFR 312.3 correct answers 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 ...

Biometrics correct answers A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System correct answers An ...