Acrp 1 - Study guides, Class notes & Summaries

ACRP CCRC Exam Review (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: When is an AE considered an ADR? Answer: In pre-approved clinical settings 1. Either a new med product OR existing med product with new usages 2. Must be causal relationship In post-marketed products 1. noxious & unintended response to a drug that occurs at normal doses Q: What is an unexpected ADR? Answer: ADR that is not consistent in nature and/or severity wi...

ACRP CCRC Exam Test with Answers 1. ADR Adverse Drug Re- action 2. Audit Reviews how the research was con- ducted; takes into account SOPs, IRB requirements & GCP (ensures compl

ACRP CCRC Exam Prep Questions and Answers What design is most commonly used for confirmatory trials? - Answer-Parallel group What are three true statements about cross-over trials? - Answer-- The subjects are their won control - The drug being studied is highly variable - Some subjects start on treatment arm A and other on treatment arm B or C What are the main reasons for having multicenter trials? - Answer-- Timeframe for recruitment - Possibility of generalization of results Tru...

Phase I Trial AKA - ANSWER Human Pharmacology Phase I Trial - ANSWER -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 - ANSWER Therapeutic Exploratory Phase II Trial - ANSWER -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying...

Air Commerce Act of 1926 - ANSWER- Created a new Aeronautics Branch known as the CAA (the precursor of the FAA) Function of the Civil Aeronautics Board (CAB) - ANSWER- Make safety rules and economic regulation of the airlines Deregulation of the airlines created this airline design - ANSWER- Hub and spoke system What act created the FAA? - ANSWER- Federal Aviation Act (FAA) What act created the TSA? - ANSWER- Transportation Safety Act (TSA) Airport and Airway Development Act of 1970 - AN...

CRA ACRP Practice Exam Questions with Correct Answers with Explanations 2024/2025 A screening log is useful for determining which of the following? 1. trial reimbursement 2. subject IP compliance 3. active recruitment efforts 4. trends regarding evaluable subjects - Correct Answer 1 and 3 only. E6 8.3.20 A screening log will provide evidence of an investigator's efforts to recruit subjects even if they are unable to identify subjects that meet entry criteria, which can help discrimina...

ACRP CCRC EXAM 2024| ACTUAL EXAM QUESTIONS WITH 100% CORRECT ANSWERS| ALREADY GRADED A+ 1. What are expected or possible consequences of over-estimation of recruitment potential?: - 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 2. What should be the first consideration when conducting a clinical trial?:...

ACRP Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: To be a qualifying clinical trial, which three requirements must be met? a. the trial has therapeutic intent, has an investigational new drug number, and enrolls patients with diagnosed disease b. the trial has therapeutic intent, enrolls patients with diagnosed disease and evaluates an item/service that falls within a medicare benefit category c. the trial has therapeutic intent, has an investi...

ACRP Practice Exam Questions and Correct Answers 100% Verified 2024/2025 A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF? a. The benefits section should be left out of the ICF, as it is not applicable. b. Wording indicating that there is no expected benefit should be included. c. A section on the benefits of clinical research in general should be added. d. A descr...