ACRP CCRC COMPREHENSIVE TEST BANK
ACRP CCRC COMPREHENSIVE TEST BANK COMPLETE QUESTIONS WITH VERIFIED
ACRP CCRC TEST PAPER QUESTIONS SOLUTIONS ACCURATE ANSWERSSOLUTIONS
COMPLETE QUESTIONS WITH VERIFIED
GRADED A PLUS
SOLUTIONS GRADED A+
⩥ 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
⩥ 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
⩥ 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?.
ACRP CCRC COMPREHENSIVE TEST BANK COMPLETE QUESTIONS WITH VERIFIED
ACRP CCRC TEST PAPER QUESTIONS SOLUTIONS ACCURATE ANSWERSSOLUTIONS
COMPLETE QUESTIONS WITH VERIFIED
GRADED A PLUS
SOLUTIONS GRADED A+
⩥ 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
⩥ 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
⩥ 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?.
