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2024 Newest |ACRP CCRC| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE
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2024 Newest |ACRP CCRC| UPDATE|COMPREHENSIVE FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED ANSWERS|GET IT 100% ACCURATE ADR - ANSWER-Adverse Drug Reaction Audit - ANSWER-Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certific...

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  • November 11, 2024
  • 48
  • 2024/2025
  • Exam (elaborations)
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  • 2024 newest acrp ccrc updatecomprehens

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2024 Newest |ACRP CCRC|2024-2025 UPDATE|COMPREHENSIVE
FREQUENTLY MOST TESTED QUESTIONS AND VERIFIED
ANSWERS|GET IT 100% ACCURATE



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)

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 1/48

,IDMC - ANSWER✔✔-Independent Data Monitoring Committee, Data & Safety

Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress;

make recommendations to continue, modify or stop


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


Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
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,*homeless


*poor


*those in nursing home


*minors


*those unable to give consent


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

Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
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, * 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)


* 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



Copyright ©EMILYCHARLENE2025. ALL RIGHTS RESERVED
Page 4/48

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