Acrp ccrc exam 100 soluti - Study guides, Class notes & Summaries

ACRP CCRC 500 Exam Questions 100% SOLUTION c) Is not necessarily causally related to drug 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 An adverse event is one which a) Is an unfavorable and unintended sign, symptom or disease b) Is one that is temporally associated with drug regardless of whether it is related or not c) a only d) a and b a) An adverse ...

ACRP CCRC Exam Prep Questions 100% SOLUTION 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 stopped because of lack of budget What should be the first consideration when conducting a clinical trial? - ANSWER Subject welfare When is t...

CCRC exam ACRP 100% SOLUTION Content Validity - ANSWER the extent to which a test samples the behavior that is of interest (such as a driving test that samples driving tasks). Double-Dummy - ANSWER The use of matching placebo to ensure blinding, when all patients receive two formulations (drug and placebo); i.e., active tablet plus placebo liquid compared to placebo tablet and active liquid. Equivalence Trial - ANSWER A trial with the primary objective of showing that the response t...

ACRP CCRC 500 Exam Questions 100% SOLUTION c) Is not necessarily causally related to drug 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 An adverse event is one which a) Is an unfavorable and unintended sign, symptom or disease b) Is one that is temporally associated with drug regardless of whether it is related or not c) a only d) a and b a) An adverse ...

ACRP CCRC exam 100% SOLUTION 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 to protect the life, health, privacy and dignity of the human subject. - ANSWER the physician (DoH) In medical research, societal/scientific interest should alway...