Exam (elaborations)

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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Uploaded on November 11, 2024
Number of pages 48
Written in 2024/2025
Type Exam (elaborations)
Contains Questions & answers

2024 newest acrp ccrc updatecomprehens

Institution Prep Tests
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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

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Page 2/48

,*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

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Page 3/48

, * 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

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Page 4/48

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