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Free ACRP-CP Practice Questions

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

Question 1

During a routine monitoring visit, a CRA discovers that three subjects were dispensed investigational product from a lot that expired two weeks ago. The drug accountability log shows the expired lot was received and stored correctly but was never flagged for quarantine. What is the CRA's MOST appropriate first action?

  1. Immediately destroy the remaining expired product and document the destruction
  2. Notify the sponsor and document the finding, then work with the site to quarantine remaining expired stock
  3. Issue a protocol deviation report for each affected subject and close the finding
  4. Instruct the site to contact all three subjects and discontinue them from the study
Show answer & explanation

Correct answer: B - Notify the sponsor and document the finding, then work with the site to quarantine remaining expired stock

Question 2

An investigator is conducting a Phase II trial in patients with moderate depression. A 17-year-old subject who meets all other eligibility criteria presents with a parent who has signed the informed consent form. The subject verbally agrees to participate but refuses to sign the assent form, saying 'my mom already signed for me.' What is the MOST appropriate action?

  1. Enroll the subject since parental consent has been obtained and the subject verbally agreed
  2. Document the verbal agreement in the source notes and proceed with enrollment
  3. Do not enroll the subject because the subject's refusal to sign the assent form indicates unwillingness to participate
  4. Contact the IRB to request a waiver of assent since parental consent was provided
Show answer & explanation

Correct answer: C - Do not enroll the subject because the subject's refusal to sign the assent form indicates unwillingness to participate

Question 3

A clinical research coordinator reviews a subject's returned medication at a scheduled visit. The subject was dispensed 30 tablets and instructed to take one daily for 30 days. The subject returns 12 tablets but reports perfect adherence. When the coordinator asks about the discrepancy, the subject states they accidentally dropped several tablets down the sink. How should this be documented?

  1. Record the subject as non-compliant with a major protocol deviation since the pill count does not match
  2. Accept the subject's explanation, adjust the pill count, and document the subject as compliant
  3. Document the discrepancy in the source record with the subject's explanation, record the actual pill count on the accountability log, and notify the investigator for assessment
  4. Discard the returned tablets and note on the drug accountability log that all tablets were consumed
Show answer & explanation

Correct answer: C - Document the discrepancy in the source record with the subject's explanation, record the actual pill count on the accountability log, and notify the investigator for assessment

Question 4

A subject in a double-blind, placebo-controlled oncology trial is admitted to the emergency department with acute liver failure. The treating physician urgently requests unblinding to guide treatment decisions. The investigator contacts the sponsor's medical monitor, who recommends against unblinding because interim efficacy data could be compromised. What is the CORRECT course of action?

  1. Defer to the sponsor's recommendation and treat the subject empirically without unblinding
  2. Unblind the subject's treatment assignment because the investigator's primary obligation is to the safety and well-being of the subject
  3. Convene an emergency IRB meeting to decide whether unblinding is justified
  4. Request the DSMB to review the case and issue a recommendation before taking action
Show answer & explanation

Correct answer: B - Unblind the subject's treatment assignment because the investigator's primary obligation is to the safety and well-being of the subject

Question 5

A sponsor's quality assurance team is conducting a routine audit at an investigative site. During the audit, the auditor discovers that the principal investigator signed and dated several informed consent forms on behalf of subjects who were unable to attend their scheduled consent visits, noting 'subject consented by phone.' The auditor should FIRST:

  1. Report the finding directly to the regulatory authority as suspected research fraud
  2. Discuss the finding with the principal investigator to understand the circumstances and document it as a critical audit finding
  3. Immediately suspend all enrollment at the site pending a full investigation
  4. Recommend that the sponsor terminate the investigator for GCP non-compliance
Show answer & explanation

Correct answer: B - Discuss the finding with the principal investigator to understand the circumstances and document it as a critical audit finding

Question 6

A subject enrolled in a cardiovascular outcomes trial reports a new onset of chest pain during a routine study visit. The investigator determines it is angina unrelated to the investigational product and treats the subject with standard medications. Three days later, the subject is hospitalized for the same chest pain. According to ICH guidelines, this event MUST be classified as:

  1. An adverse event only, because the investigator determined it was unrelated to the investigational product
  2. A serious adverse event, because any hospitalization meets the seriousness criteria regardless of causality
  3. An adverse drug reaction, because it occurred during investigational product administration
  4. A protocol deviation, because the subject received a concomitant medication that may interact with the study drug
Show answer & explanation

Correct answer: B - A serious adverse event, because any hospitalization meets the seriousness criteria regardless of causality

Question 7

A new study coordinator joins a site mid-trial and begins performing protocol-required electrocardiograms (ECGs) on study subjects. During the next monitoring visit, the CRA reviews the delegation of authority log and finds the new coordinator's name is not listed for ECG procedures, although she has documented training certificates for ECG operation. What should the CRA do?

  1. Accept the ECGs as valid since the coordinator has documented ECG training certificates
  2. Note the finding in the monitoring report, request the PI update the delegation log immediately, and assess whether the ECG data collected can be accepted per protocol
  3. Reject all ECG data collected by the coordinator and require the subjects to return for repeat ECGs
  4. Report the coordinator to the sponsor as performing unauthorized study tasks
Show answer & explanation

Correct answer: B - Note the finding in the monitoring report, request the PI update the delegation log immediately, and assess whether the ECG data collected can be accepted per protocol

Question 8

A data manager notices that a site has entered a systolic blood pressure of 42 mmHg for a subject at a routine visit. The edit check flags the value as below the expected range. Upon query, the site responds that the value is correct as recorded in the source document. What is the MOST appropriate next step?

  1. Accept the value and close the query since the site confirmed it matches the source document
  2. Override the edit check and change the value to a clinically plausible number
  3. Escalate to the monitor to verify the source document at the next site visit and assess whether the value represents a potential safety event or a transcription error at the source level
  4. Delete the data point and mark it as missing data in the database
Show answer & explanation

Correct answer: C - Escalate to the monitor to verify the source document at the next site visit and assess whether the value represents a potential safety event or a transcription error at the source level

Question 9

A sponsor is designing a Phase III non-inferiority trial comparing a new oral anticoagulant to the current standard of care. The primary analysis will use the intent-to-treat population. A biostatistician recommends also conducting the primary analysis using the per-protocol population. Why is the per-protocol analysis PARTICULARLY important in a non-inferiority trial?

  1. Per-protocol analysis increases the statistical power by excluding subjects who dropped out early
  2. In non-inferiority trials, protocol violations and non-adherence can bias the ITT analysis toward showing no difference, which falsely favors the conclusion of non-inferiority
  3. Regulatory authorities only accept per-protocol analyses for non-inferiority trials
  4. The per-protocol population removes placebo responders who would otherwise dilute the treatment effect
Show answer & explanation

Correct answer: B - In non-inferiority trials, protocol violations and non-adherence can bias the ITT analysis toward showing no difference, which falsely favors the conclusion of non-inferiority

Question 10

An investigative site has completed the last subject's last visit in a Phase III trial. The sponsor informs the site that no marketing application will be filed for the investigational product. The principal investigator asks how long the essential documents must be retained. According to ICH GCP, the MINIMUM retention period is:

  1. At least 5 years after the last subject's last visit
  2. At least 2 years after the formal discontinuation of clinical development of the investigational product
  3. At least 15 years, as required for all clinical trial records
  4. Until the sponsor provides written notification that records may be destroyed, with no minimum specified
Show answer & explanation

Correct answer: B - At least 2 years after the formal discontinuation of clinical development of the investigational product

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