ACRP CP FINAL / ACRP CP ACTUAL FINAL EXAM
COMPLETE EXAM WITH REAL QUESTIONS AND
CORRECT VERIFIED ANSWERS LATEST UPDATE |
GUARANTEED PASS A+ (REVISED EXAM)
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
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? - 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)
* 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
*Benefits
*Alternatives to participating
*Compensation
* Compensation for trial related outcomes
*Voluntary nature of trial
*Who has access to direct records
*Confidentiality of research records
*New information will be made available to subject
*Who to Contact
*Involuntary termination
*Trial Duration
*Subjects to be enrolled
Non-therapeutic trials can be conducted with consent from legal rep IF - ANSWER:
*trial objectives cannot be met by personal subject consent
*low risk
*trial is not prohibited by law
*IRB has approved such inclusion
How long must documents be retained per GCP? - ANSWER: At least 2 years after
last approved marketing application (organizations/sponsors, etc usually set a longer
required period of 5-7 years)
When to submit SAE to sponsor? - ANSWER: Immediately (usually within 24 hours)
Sponsors role - ANSWER: *Complete & ensure SOPs are followed
*seeks agreements from all parties
*may use CRO to oversee; however, the sponsor is ultimately responsible
CRO - ANSWER: Contract Research Organization
COMPLETE EXAM WITH REAL QUESTIONS AND
CORRECT VERIFIED ANSWERS LATEST UPDATE |
GUARANTEED PASS A+ (REVISED EXAM)
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
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? - 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)
* 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
*Benefits
*Alternatives to participating
*Compensation
* Compensation for trial related outcomes
*Voluntary nature of trial
*Who has access to direct records
*Confidentiality of research records
*New information will be made available to subject
*Who to Contact
*Involuntary termination
*Trial Duration
*Subjects to be enrolled
Non-therapeutic trials can be conducted with consent from legal rep IF - ANSWER:
*trial objectives cannot be met by personal subject consent
*low risk
*trial is not prohibited by law
*IRB has approved such inclusion
How long must documents be retained per GCP? - ANSWER: At least 2 years after
last approved marketing application (organizations/sponsors, etc usually set a longer
required period of 5-7 years)
When to submit SAE to sponsor? - ANSWER: Immediately (usually within 24 hours)
Sponsors role - ANSWER: *Complete & ensure SOPs are followed
*seeks agreements from all parties
*may use CRO to oversee; however, the sponsor is ultimately responsible
CRO - ANSWER: Contract Research Organization
