Exam (elaborations)

ACRP CCRC Exam Study Guide Solutions

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Course
CCRC

Institution
CCRC

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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Uploaded on November 3, 2024
Number of pages 41
Written in 2024/2025
Type Exam (elaborations)
Contains Questions & answers

acrp ccrc exam study guide solutions

Institution CCRC
Course CCRC

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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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