Comprehensive GCP and Clinical Trial
Principles for ACRP Exam Questions and
Answers with Verified Solutions | Latest
Updated 2026
What is the primary purpose of Protect the rights, safety, and
Good Clinical Practice (GCP)? well-being of trial subjects and
ensure credibility of data.
What takes priority in clinical The rights, safety, and well-being of
research? subjects.
What is the ethical foundation Declaration of Helsinki.
document for human subject
research?
What are the three core Respect for persons; Beneficence;
ethical principles? Justice.
What does respect for persons Autonomy and informed consent.
mean?
What does beneficence mean? Maximize benefits and minimize
harm.
What does justice mean? Fair and equitable subject selection.
What guideline governs GCP? ICH E6.
, Which version of ICH E6 is E6 (R2) with principles aligned to E6
referenced for 2025 exams? (R3).
What is the primary focus of Quality by design, risk-based
ICH E6 (R3)? approach, subject protection.
Does the ACRP exam test FDA No, the exam is based on ICH and
regulations? global GCP principles.
Who has overall responsibility Principal Investigator (PI).
for trial conduct at the site?
Can a PI delegate trial tasks? Yes.
Can a PI delegate No.
responsibility?
How must delegation be Delegation of Authority Log.
documented?
What must delegation show? Task delegated and staff
qualification.
Who supervises the research Principal Investigator.
team?
Who manages day-to-day trial Clinical Research Coordinator (CRC).
operations?
Is the CRC responsible for Yes, under PI supervision.
subject safety?
Principles for ACRP Exam Questions and
Answers with Verified Solutions | Latest
Updated 2026
What is the primary purpose of Protect the rights, safety, and
Good Clinical Practice (GCP)? well-being of trial subjects and
ensure credibility of data.
What takes priority in clinical The rights, safety, and well-being of
research? subjects.
What is the ethical foundation Declaration of Helsinki.
document for human subject
research?
What are the three core Respect for persons; Beneficence;
ethical principles? Justice.
What does respect for persons Autonomy and informed consent.
mean?
What does beneficence mean? Maximize benefits and minimize
harm.
What does justice mean? Fair and equitable subject selection.
What guideline governs GCP? ICH E6.
, Which version of ICH E6 is E6 (R2) with principles aligned to E6
referenced for 2025 exams? (R3).
What is the primary focus of Quality by design, risk-based
ICH E6 (R3)? approach, subject protection.
Does the ACRP exam test FDA No, the exam is based on ICH and
regulations? global GCP principles.
Who has overall responsibility Principal Investigator (PI).
for trial conduct at the site?
Can a PI delegate trial tasks? Yes.
Can a PI delegate No.
responsibility?
How must delegation be Delegation of Authority Log.
documented?
What must delegation show? Task delegated and staff
qualification.
Who supervises the research Principal Investigator.
team?
Who manages day-to-day trial Clinical Research Coordinator (CRC).
operations?
Is the CRC responsible for Yes, under PI supervision.
subject safety?
