ACRP-CP CERTIFICATION EXAM |180 COMPLETE QUESTIONS WITH
EXPERT SOLUTIONS | 2026 LATEST UPDATED | GET A+
What are the 4 phases of clinical trials? - (answer)Phase I: Safety, dose finding, PK/PD.
Phase II: Efficacy, dose response, side effects.
Phase III: Large-scale efficacy, risk-benefit, labeling support.
Phase IV: Post-marketing, long-term safety.
How often is the ECO updated and by what process? - (answer)Every 5 years through a role
delineation study (job analysis) led by certified subject matter experts.
Difference between standard of care and clinical research protocol requirements? -
(answer)Standard of care = routine medical practice; protocol = study-specific procedures that
may differ.
What is clinical equipoise? - (answer)Genuine uncertainty about whether a treatment is
beneficial.
What is therapeutic misconception? - (answer)When participants mistakenly believe research
guarantees therapeutic benefit.
Key documents ensuring subject protection? - (answer)Investigator's Brochure, Protocol,
Informed Consent Documents.
Examples of vulnerable populations? - (answer)Children, prisoners, pregnant women,
cognitively impaired.
Purpose of unblinding procedures? - (answer)To protect safety or when medically necessary.
,What are protocol deviations vs. violations? - (answer)Deviation = unplanned change from
protocol; Violation = significant breach impacting subject safety/data integrity.
Main stakeholders in clinical research? - (answer)Sponsors, CROs, IRBs/IECs, regulatory
authorities, investigators, participants.
4 phases of clinical trials - (answer)Phase I (safety), Phase II (efficacy/dose), Phase III
(confirmation), Phase IV (post-marketing).
Role of IRB/IEC? - (answer)Protect participant rights/safety, review/approve protocols, ensure
compliance.
What is a DSMB review? - (answer)Data Safety Monitoring Board review of safety/efficacy
during trial.
What are GCPs? - (answer)Good Clinical Practices - international quality standard ensuring
safety, rights, and integrity.
Investigator product responsibilities? - (answer)Proper storage, dispensing, accountability of
investigational drugs/devices.
What is CAPA? - (answer)Corrective and Preventive Action - steps to fix and prevent issues.
What is source data verification (SDV)? - (answer)Checking that reported trial data matches
original records.
What are site initiation, maintenance, and closeout activities? - (answer)Startup training, ongoing
monitoring, and final trial closure.
,What are essential trial documents? - (answer)Trial Master File (TMF), delegation logs,
informed consent, case report forms.
What is non-compliance management? - (answer)Identifying, documenting, and addressing
deviations from protocol/regulations.
What is investigational product accountability? - (answer)Tracking, documenting, and verifying
drug/device receipt, use, and return.
What are record retention practices? - (answer)Keeping study records for required regulatory
period; secure destruction afterward.
Examples of trial design types? - (answer)Randomized, double-blind, crossover.
What is ALCOA-C in documentation? - (answer)Attributable, Legible, Contemporaneous,
Original, Accurate, Complete.
Purpose of eligibility requirements? - (answer)Protect subjects and ensure reliable results.
What is an Investigator's Brochure (IB)? - (answer)Reference document summarizing
preclinical/clinical data on investigational product.
What is an audit trail? - (answer)Record of data entry, modification, and correction in electronic
systems.
What is the role of CAPA in clinical research tasks? - (answer)To create and implement
corrective/preventive actions for identified issues.
What does feasibility assessment involve? - (answer)Determining if a site can realistically
execute a protocol (staff, resources, timeline).
, What is the role of monitoring in trials? - (answer)Ensure compliance, data accuracy, subject
safety.
What is the difference between SDR and SDV? - (answer)SDR = Source Data Review (quality);
SDV = Source Data Verification (accuracy vs. records).
How should adverse events be managed? - (answer)Classified, documented, reported promptly to
IRB/IEC and sponsor per regulations.
Standard of care vs. protocol requirements? - (answer)Standard of care = routine treatment;
protocol requirements = research-specific procedures.
Examples of past/current ethical issues in research? - (answer)Lack of diversity, exploitation,
Tuskegee Syphilis Study
How are risks vs. benefits evaluated? - (answer)Risks minimized, benefits maximized, and
balance assessed by IRB/IEC
Elements of informed consent? - (answer)Purpose, risks, benefits, alternatives, confidentiality,
voluntary participation
What is assent? - (answer)Agreement from individuals (e.g., minors) not legally able to give
consent
Protocol deviation vs. violation? - (answer)Deviation = minor departure, usually no safety/data
impact; Violation = significant noncompliance impacting subject/data
Recruitment and retention strategies? - (answer)Outreach, cultural sensitivity, participant
reminders, incentives
EXPERT SOLUTIONS | 2026 LATEST UPDATED | GET A+
What are the 4 phases of clinical trials? - (answer)Phase I: Safety, dose finding, PK/PD.
Phase II: Efficacy, dose response, side effects.
Phase III: Large-scale efficacy, risk-benefit, labeling support.
Phase IV: Post-marketing, long-term safety.
How often is the ECO updated and by what process? - (answer)Every 5 years through a role
delineation study (job analysis) led by certified subject matter experts.
Difference between standard of care and clinical research protocol requirements? -
(answer)Standard of care = routine medical practice; protocol = study-specific procedures that
may differ.
What is clinical equipoise? - (answer)Genuine uncertainty about whether a treatment is
beneficial.
What is therapeutic misconception? - (answer)When participants mistakenly believe research
guarantees therapeutic benefit.
Key documents ensuring subject protection? - (answer)Investigator's Brochure, Protocol,
Informed Consent Documents.
Examples of vulnerable populations? - (answer)Children, prisoners, pregnant women,
cognitively impaired.
Purpose of unblinding procedures? - (answer)To protect safety or when medically necessary.
,What are protocol deviations vs. violations? - (answer)Deviation = unplanned change from
protocol; Violation = significant breach impacting subject safety/data integrity.
Main stakeholders in clinical research? - (answer)Sponsors, CROs, IRBs/IECs, regulatory
authorities, investigators, participants.
4 phases of clinical trials - (answer)Phase I (safety), Phase II (efficacy/dose), Phase III
(confirmation), Phase IV (post-marketing).
Role of IRB/IEC? - (answer)Protect participant rights/safety, review/approve protocols, ensure
compliance.
What is a DSMB review? - (answer)Data Safety Monitoring Board review of safety/efficacy
during trial.
What are GCPs? - (answer)Good Clinical Practices - international quality standard ensuring
safety, rights, and integrity.
Investigator product responsibilities? - (answer)Proper storage, dispensing, accountability of
investigational drugs/devices.
What is CAPA? - (answer)Corrective and Preventive Action - steps to fix and prevent issues.
What is source data verification (SDV)? - (answer)Checking that reported trial data matches
original records.
What are site initiation, maintenance, and closeout activities? - (answer)Startup training, ongoing
monitoring, and final trial closure.
,What are essential trial documents? - (answer)Trial Master File (TMF), delegation logs,
informed consent, case report forms.
What is non-compliance management? - (answer)Identifying, documenting, and addressing
deviations from protocol/regulations.
What is investigational product accountability? - (answer)Tracking, documenting, and verifying
drug/device receipt, use, and return.
What are record retention practices? - (answer)Keeping study records for required regulatory
period; secure destruction afterward.
Examples of trial design types? - (answer)Randomized, double-blind, crossover.
What is ALCOA-C in documentation? - (answer)Attributable, Legible, Contemporaneous,
Original, Accurate, Complete.
Purpose of eligibility requirements? - (answer)Protect subjects and ensure reliable results.
What is an Investigator's Brochure (IB)? - (answer)Reference document summarizing
preclinical/clinical data on investigational product.
What is an audit trail? - (answer)Record of data entry, modification, and correction in electronic
systems.
What is the role of CAPA in clinical research tasks? - (answer)To create and implement
corrective/preventive actions for identified issues.
What does feasibility assessment involve? - (answer)Determining if a site can realistically
execute a protocol (staff, resources, timeline).
, What is the role of monitoring in trials? - (answer)Ensure compliance, data accuracy, subject
safety.
What is the difference between SDR and SDV? - (answer)SDR = Source Data Review (quality);
SDV = Source Data Verification (accuracy vs. records).
How should adverse events be managed? - (answer)Classified, documented, reported promptly to
IRB/IEC and sponsor per regulations.
Standard of care vs. protocol requirements? - (answer)Standard of care = routine treatment;
protocol requirements = research-specific procedures.
Examples of past/current ethical issues in research? - (answer)Lack of diversity, exploitation,
Tuskegee Syphilis Study
How are risks vs. benefits evaluated? - (answer)Risks minimized, benefits maximized, and
balance assessed by IRB/IEC
Elements of informed consent? - (answer)Purpose, risks, benefits, alternatives, confidentiality,
voluntary participation
What is assent? - (answer)Agreement from individuals (e.g., minors) not legally able to give
consent
Protocol deviation vs. violation? - (answer)Deviation = minor departure, usually no safety/data
impact; Violation = significant noncompliance impacting subject/data
Recruitment and retention strategies? - (answer)Outreach, cultural sensitivity, participant
reminders, incentives
