Acrc Study guides, Class notes & Summaries

ACRP Key Terms for CCRC exam, CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 3.4.21

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 Already Graded A+

CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set Rated A+ 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 Feasibility of a Study Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjec...

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 ...

What is ICH E2A? - Answer- Clinical Safety Data Management -Definitions and Standards for Expedited Reporting -This document gives standard definitions and terminology for key aspects of clinical safety reporting. -It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development. ICH E2A: An adverse event is defined as one which a) Results in hospitalization b) Causes a disability c) Is not necessa...

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 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 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 ...

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 ...