Acrp 1 - Study guides, Class notes & Summaries

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...

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 - ANSWER- Cr...

ACRP CP EXAM LATEST VERSION|QUESTION WITH CORRECT ANSWERS|A RATED 2024 Belmont Report (1979) Correct Answer ethical principles and guidelines for the protection of human subjects of research. Respect for persons Correct Answer individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection An autonomous person Correct Answer A person capable of deliberation about personal goals and of acting under the direction of such deliberation B...

ACRP CCRC Practice Questions & Answers, VERIFIED/ 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 (# returned) = 32 (# actually taken), 8 days X 8 tablets per day =64 (# that should have been taken, 32 (# taken)/64 (# should have been taken) = .5 or 50% ...

ACRP Bootcamp Exam (61 Questions) With 100% Correct Verified Answers The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (11T) c. Post market device registries d. outcome and health services research Who is ultimately responsible for all aspects of the research conducted...

ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: Which of the following is an unexpected adverse event? a) A report which adds significant information to an already documented serious adverse event b) A report of interstitial nephritis in a patient with acute renal failure c) A report of fulminant hepatitis in patient with an initial report of hepatitis d) All of the above Answer: d) All of the above Q: For expedited reportin...

ACRP CCRA Exam Prep 100% SOLUTION 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 methodo...

ACRP CCRA Exam Review Questions and answers, VERIFIED/ Who is considered "vulnerable"? - -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 study) and is asymptomatic. This is considered an SAE because colon cancer is life-threatening. True or False? - -FALSE Who is responsible for designing the ...

ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigators' meeting. Following the meeting, the entry criteria are altered to facilitate the recruitment and retention of eligible subject. Prior to trial start-up, the regulatory binder must include: 1.An IRB/IEC letter of approval for the amended protocol 2.An IRB/IEC ...

ACRP CCRC exam Questions and Answers 100% Correct 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 inter...