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Free ACRP-PI Practice Questions

10 free, exam-style Certified Principal Investigator (ACRP-PI) practice questions with answers and explanations. No signup required. Work through them below, then take the full free ACRP-PI practice test to study every exam domain.

The ACRP-PI exam has 125 questions and runs 3 hours.

These 10 free ACRP-PI questions are organized by exam domain, so you can see how each part of the Certified Principal Investigator blueprint is tested. Reveal the answer and explanation under each question.

Domain 1: Scientific Rationale and Principles of Research Design 15% of exam

Question 1

A trial is designed to demonstrate that a new therapy is not unacceptably worse than the standard treatment, within a predefined margin. This describes which type of study design?

  1. A superiority design, which sets out to prove the new therapy works better than the standard
  2. An equivalence design, which sets out to prove the two therapies perform essentially the same
  3. A non-inferiority design, showing the therapy is not worse by a set margin
  4. A crossover design, in which every participant receives both therapies in a set sequence
Show answer & explanation

Correct answer: C - A non-inferiority design, showing the therapy is not worse by a set margin

Domain 2: Ethical and Safety Considerations 22% of exam

Question 2

A participant develops a severe headache that is intense but resolves within hours and requires no intervention. The investigator must classify the event. Under ICH GCP, the headache's intensity should be recorded as its:

  1. Seriousness, since any event a participant describes as severe meets the serious criteria
  2. Severity, which describes intensity and is separate from whether an event is serious
  3. Causality, since the intensity of an event reflects how strongly the product caused it
  4. Expectedness, since an event reported as severe is by definition unexpected
Show answer & explanation

Correct answer: B - Severity, which describes intensity and is separate from whether an event is serious

Question 3

A participant is admitted for an overnight inpatient stay for observation after fainting at a study visit. They recover fully and are discharged the next morning. How should this event be classified?

  1. A non-serious adverse event, given the full overnight recovery and routine discharge
  2. A protocol deviation, since the planned study visit could not proceed as written
  3. An adverse event of special interest, since the fainting was witnessed at the site
  4. A serious adverse event, because it required inpatient hospitalization
Show answer & explanation

Correct answer: D - A serious adverse event, because it required inpatient hospitalization

Question 4

Midway through a visit, an investigator recognizes that following the protocol exactly would expose the participant to an immediate safety hazard. What is the correct course of action under ICH GCP?

  1. Deviate to protect the participant, then document and promptly report it
  2. Wait for written IRB/IEC approval before any action that departs from the approved protocol
  3. Continue exactly per protocol, since departures are never allowed without prior sponsor authorization
  4. Immediately withdraw the participant from the study and record no protocol deviation
Show answer & explanation

Correct answer: A - Deviate to protect the participant, then document and promptly report it

Domain 3: Product Development and Regulation 12% of exam

Question 5

A site is preparing for two separate external reviews of its trial conduct: one arranged by the sponsor and one conducted by a regulatory authority. Which statement correctly distinguishes these activities?

  1. Both count as inspections, since any external review of a site's trial records is an inspection
  2. An audit is done by or for the sponsor; an inspection is done by a regulatory authority
  3. An audit is what a regulatory authority performs; an inspection is what the sponsor arranges
  4. Both count as audits, since the sponsor and the authority carry the same oversight duties
Show answer & explanation

Correct answer: B - An audit is done by or for the sponsor; an inspection is done by a regulatory authority

Domain 4: Clinical Trial Operations 21% of exam

Question 6

An investigator delegates several study-specific procedures to a qualified coordinator and documents this on the delegation log. With respect to ICH GCP, responsibility for the overall conduct of the trial at the site now belongs to:

  1. The coordinator, since the delegation log formally transferred those duties to them
  2. The sponsor, since the sponsor holds ultimate accountability for the whole trial
  3. The investigator, who keeps responsibility for the trial despite delegating tasks
  4. The monitor, whose oversight of the site makes them accountable for its conduct
Show answer & explanation

Correct answer: C - The investigator, who keeps responsibility for the trial despite delegating tasks

Question 7

After a recurring data-entry error is identified at a site, the investigator updates the workflow and retrains staff specifically so the same error cannot happen again. Within a CAPA framework, redesigning the process to stop recurrence is best described as the:

  1. Corrective action, since the immediate aim is to fix the error that was already found
  2. Root cause analysis, since the focus is on uncovering why the error first occurred
  3. Risk assessment, since the focus is on estimating how likely future errors will be
  4. Preventive action, since the change is aimed at stopping the error from happening again
Show answer & explanation

Correct answer: D - Preventive action, since the change is aimed at stopping the error from happening again

Domain 5: Study and Site Management 17% of exam

Question 8

A site refrigerator storing the investigational product records a temperature outside the labeled storage range overnight. The next morning, what should the site do FIRST?

  1. Discard all affected product right away so that compromised drug is never dispensed
  2. Quarantine the product, withhold it from use, and notify the sponsor for guidance
  3. Keep dispensing the product, since one brief overnight excursion is unlikely to matter
  4. Update the storage log to the labeled range and continue dispensing as normal
Show answer & explanation

Correct answer: B - Quarantine the product, withhold it from use, and notify the sponsor for guidance

Question 9

An investigator is reconciling investigational product at the site. For the records to reconcile correctly, the quantity of product received should equal the quantity:

  1. Dispensed plus returned plus destroyed plus what remains in inventory
  2. Dispensed minus whatever participants returned during the study period
  3. Dispensed plus the number of participants who are currently enrolled
  4. Remaining after subtracting any product that expired during the study
Show answer & explanation

Correct answer: A - Dispensed plus returned plus destroyed plus what remains in inventory

Domain 6: Data Management 13% of exam

Question 10

A study has closed at a site and the investigator wants to know how long essential documents must be kept. Under ICH GCP, at a minimum, these records must be retained:

  1. For one year following the final participant's last completed study visit at the site
  2. Until the site's next annual IRB/IEC continuing review has been formally closed out
  3. Until the sponsor finishes monitoring and has collected the full trial master file
  4. At least 2 years after the last marketing approval or after development stops, whichever is longer
Show answer & explanation

Correct answer: D - At least 2 years after the last marketing approval or after development stops, whichever is longer

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