Acrp ccr - Study guides, Class notes & Summaries
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ACRP CCRC, CCRC Study Set Already Graded A+
- Exam (elaborations) • 156 pages • 2023
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ACRP CCRC, CCRC Study Set Already Graded A+ 
 
ADR 
Adverse Drug Reaction 
Audit 
Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) 
Brainpower 
Audit Certificate 
Confirmation audit took place 
Audit Report 
Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance 
Audit Trail 
Documentation of audit events 
Single Blind Study 
Subjects Unaware 
Double Blind Study ...
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ACRP CCRC Exam Prep (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A
- Exam (elaborations) • 62 pages • 2024
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ACRP CCRC Exam Prep (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A 
 
Q: In the RBDM process, what's the next step after determining the end goal? 
 
 
Answer: 
Risk assessment. 
 
 
 
Q: True or False? A CRC claims that you doin't need to assess the impact of your risk management efforts on an ongoing basis as long as the plan was executed properly. 
 
 
Answer: 
False 
 
 
 
Q: How is the seriousness of a risk calculated? 
 
 
Answer: 
Likelihood of risk ...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
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 
Clinical event, measurable indicator, subject reported response 
Brainpower 
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Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
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ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A
- Exam (elaborations) • 34 pages • 2024
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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 ...
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ACRP CCRC Exam Prep Questions and Correct Answers 2024/2025
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ACRP CCRC Exam Prep Questions and Correct Answers 2024/2025 
What are expected or possible consequences of over-estimation of recruitment potential? - Correct 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? - Correct Answer S...
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ACRP CCRC Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A
- Exam (elaborations) • 35 pages • 2024
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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...
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set
- Exam (elaborations) • 214 pages • 2023
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CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 
 
Clinical Trial 
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 
Clinical event, measurable indicator, subject reported response 
Brainpower 
Read More 
Feasibility of a Study 
Assessment of resource needs, regulator requirements, and potential level of risk of ha...
-
ACRP CCRC, *CCRC Study Set With Complete Solutions
- Exam (elaborations) • 154 pages • 2024
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ADR - Answer Adverse Drug Reaction 
Audit - Answer Reviews how the research was conducted; takes into account SOPs, 
IRB requirements & GCP (ensures compliance) 
Audit Certificate - Answer Confirmation audit took place 
Audit Report - Answer Written Evaluation - not regularly made available to regulatory 
body; only when serious evidence exists concerning non-compliance 
Audit Trail - Answer Documentation of audit events 
Single Blind Study - Answer Subjects Unaware 
Double Blind Study - Answer ...
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ACRP CCRC exam Questions and Answers 100% Correct
- Exam (elaborations) • 32 pages • 2024
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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...
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ACRP CCRC Study Guide (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A
- Exam (elaborations) • 55 pages • 2024
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ACRP CCRC Study Guide (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A 
 
Q: "Approval" (in relation to Institutional Review Boards) 
 
Answer: 
 The affirmative de- cision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. 
 
 
Q: Audit 
 
Answer: 
 A systematic and independent exa...
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