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ACRP CCRC Exam Study Guide Solutions
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ACRP CCRC Exam Study Guide Solutions 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 ...

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  • November 3, 2024
  • 41
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • acrp ccrc exam study guide solutions

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  • CCRC
  • CCRC

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KaylinHoffman

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Copyright © KAYLIN 2024/2025 ACADEMIC YEAR. ALL RIGHTS RESERVED FIRST PUBLISH NOVEMBER, 2024




ACRP CCRC Exam Study Guide Solutions


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✔✔-Subjects & Researchers are unaware


Comparator - ANSWER✔✔-Item used as an active control references in a clinical trail


Coordinating Committee - ANSWER✔✔-Group a sponsor comprises to coordinate multi-center trials


Coordinating Investigator - ANSWER✔✔-An investigator who oversees multiple sites of a clinical trial

(multicenter)


IDMC - ANSWER✔✔-Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB),

Data Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or

stop




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IEC - ANSWER✔✔-Independent Ethics Committee; group who oversees protection, rights, safety & well-

being of human subjects


Investigator's Brochure - ANSWER✔✔-Compilation of data on an investigational product used in human

subjects


Legally acceptable representative - ANSWER✔✔-person whom is lawfully able to consent on behalf of

another


SAE - ANSWER✔✔-Serious Adverse Event - Results in death, is life-threatening, requires long-term

hospitalization, results in long term disability/hospitalization incapacitation or is a congenital birth defect


Source data - ANSWER✔✔-original clinical information from source documents (medical record

information)


Vulnerable subjects - ANSWER✔✔-*Hierarchical structure employees


*armed forces


*detainees


*incurable disease pts


*homeless


*poor


*those in nursing home


*minors


*those unable to give consent



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ICH - ANSWER✔✔-International Conference on Harmonization


Principles of ICH & GCP - ANSWER✔✔-*Protect research subjects


*conduct research as it has been approved


*research should be clear, organized & approved by an IRB/IEC


IRB / IEC Responsibilities - ANSWER✔✔-*Oversee principles of ICH/GCP


*Make sure the PI / Co-Is are qualified


* Review studies at least once a year


Requirements of an IRB - ANSWER✔✔-* at least 5 members


* one non-scientific member


* one non-institute member


What needs reported to the IRB? - ANSWER✔✔-*Changes / deviations from protocol due to unforeseen

hazard


* changes to subject risk


* adverse events


* new info that may impact subject safety


Payment to subjects must be.... - ANSWER✔✔-prorated & not contingent on subject completing study


Investigator Responsibilities - ANSWER✔✔-*Maintain delegation long


*Ensure staff are trained/informed about the protocol (give delegated tasks)



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* Ascertain reason study participant withdraws consent while respecting their privacy & rights


* Adhere to approved protocol


*Document & explain any deviations from approved protocol


* Process protocol amendments according to GCP


*Manage proper storage & care for trial devices/drugs. (PI can delegate this task to trained professional -

PharmD, etc)


Protocol amendments should be submitted to - ANSWER✔✔-1. IRB


2. Sponsor


3. Regulatory Authority


Changes in risk to subjects... - ANSWER✔✔-should be included & approved on an updated ICF - patients

enrolled should be re-consented


Consenting illiterate subjects - ANSWER✔✔-is okay, but must have impartial witness present


Necessary aspects of ICF - ANSWER✔✔-*Trial involves research


*Trial purposes


*Treatments - randomization aspect if applicable


* Procedures


*Subject responsibilities


*Experimental Aspects of trial


*Risks


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