Free ACRP-PM Practice Questions

Question 1

Trial-wide primary-endpoint missingness is 3%, below a trial's prespecified 5% quality tolerance limit. One site's rate is 18%, above the monitoring plan's 10% site-level investigation trigger. Both measures include only participants whose endpoint window has closed. No immediate safety threat is identified. How should the project manager respond to this combination of results?

Accepted Answer

Initiate a targeted review of the site's endpoint collection and act on the findings.

Answer

Maintain routine monitoring because the overall quality tolerance limit is met.

Answer

Treat the missing values solely as an imputation issue for the final statistical analysis.

Answer

Suspend enrollment at every site until an independent audit establishes the cause of the missing endpoints.

Question 2

A recruitment campaign begins reaching a broader audience. Referrals increase, but the screen-failure proportion rises from 24% to 61%, and randomizations fall behind target. Among candidates confirmed eligible, 92% still proceed to randomization. Time from eligibility confirmation to randomization and early participant retention are unchanged. Where would an additional recruitment investment most directly address the emerging bottleneck?

Accepted Answer

Revise referral prescreening around the eligibility criteria responsible for the additional screen failures.

Answer

Add staff to shorten the interval between confirming eligibility and completing the randomization process.

Answer

Add participant-counseling sessions to reduce refusal of randomization among candidates who meet the eligibility criteria.

Answer

Extend follow-up clinic hours to reduce the risk that randomized participants leave the study early.

Question 3

An 11-year-old agrees to join the main trial but refuses an optional research-only blood draw after an age-appropriate explanation. The investigator confirms that the child understands the choice. The parent has given permission for both activities. The approved protocol allows participation without the optional sample, which offers no direct clinical benefit. How should the site's procedure plan reflect these decisions?

Accepted Answer

Omit the optional draw, document the refusal, and continue the main-trial activities covered by parental permission and the child's assent.

Answer

Perform the optional draw under parental permission and document the child's objection.

Answer

Withdraw the child from the trial because assent and parental permission no longer match.

Answer

Defer all trial procedures until the ethics committee resolves the parent-child disagreement.

Question 4

At quarter-end, a trial has paid $240,000 for completed work. Another $60,000 of accepted services has not been invoiced. Open purchase orders total $200,000 and already include those $60,000 of accepted services; the balance covers future contracted work. Completing the study will also require $40,000 of work not yet contracted. No other costs are expected. Against an approved total budget of $450,000, what forecast should be presented to leadership?

Accepted Answer

$480,000 at completion, requiring $30,000 above the approved budget.

Answer

$420,000 at completion, leaving $30,000 below the approved budget.

Answer

$540,000 at completion, requiring $90,000 above the approved budget.

Answer

$440,000 at completion, leaving $10,000 below the approved budget.

Question 5

Wrong-version consent forms recur after a corrective and preventive action plan has retrained every coordinator and updated the central document portal. Review of the affected visits shows that staff printed obsolete blank templates from local clinic drives. Staff can accurately explain the consent requirements. Which revision most directly addresses the demonstrated cause of recurrence?

Accepted Answer

Retire obsolete local templates and verify the approved version before each consent discussion.

Answer

Repeat the consent course and require each coordinator to pass a second knowledge assessment before consenting participants.

Answer

Increase retrospective consent-form sampling so monitors can identify more wrong-version events during the next monitoring cycle.

Answer

Add an investigator review of signed forms after each consent discussion.

Question 6

During review of a trial's electronic data-capture design, the project manager notices that selecting 'study drug discontinued' automatically closes all later efficacy-assessment forms. The primary estimand uses a treatment-policy strategy for drug discontinuation. The protocol permits participants who stop drug to continue the scheduled assessments, and their consent covers that follow-up. Which design requirement follows from the estimand?

Accepted Answer

Keep scheduled outcome forms available when treatment stops but consented follow-up continues.

Answer

Replace each later outcome with the last value obtained while the participant was receiving study drug.

Answer

Reopen efficacy forms only when the participant restarts the originally assigned investigational treatment.

Answer

Retain post-discontinuation assessments as safety data but exclude them from the primary efficacy records.

Question 7

Two activities start together for a site's activation: contract execution takes 12 elapsed days and laboratory qualification takes 9. Site initiation and final release then take 3 days and cannot start until both activities finish. There are no other dependencies. The sponsor needs activation within 13 elapsed days. Each proposed acceleration is feasible, costs the same, and preserves all required checks. Which proposal achieves the requested date?

Accepted Answer

Shorten contract execution by 2 days, leaving laboratory qualification and site initiation unchanged.

Answer

Shorten laboratory qualification by 2 days, without changing contract execution or site initiation.

Answer

Shorten contract execution and laboratory qualification by 1 day each, leaving site initiation unchanged.

Answer

Shorten site initiation and final release by 1 day, leaving both preceding activities unchanged.

Question 8

A sponsor receives a report of unexpected bronchospasm requiring urgent treatment to prevent respiratory failure during an investigational-drug trial. The participant was discharged without inpatient admission. The investigator documents a medically important event and a reasonable possibility of drug causation, but confirms that it was not life-threatening when it occurred. The sponsor has all minimum reporting information today. Under ICH E2A, which expedited-reporting category and maximum initial-report timeline apply?

Accepted Answer

A serious, non-life-threatening unexpected reaction, with an initial report no later than 15 calendar days after today's receipt.

Answer

A life-threatening unexpected reaction, with an initial report no later than 7 calendar days after today's receipt.

Answer

A nonserious unexpected reaction, to be included in routine safety reporting because no inpatient admission occurred.

Answer

An incompletely assessed reaction, with the expedited-reporting clock beginning after the sponsor confirms drug causation.

Question 9

User acceptance testing for a nonurgent protocol amendment finds that unanswered electronic symptom questions are stored as zero. The trial's rating scale runs from 0, meaning no symptoms, to 10, meaning the worst imaginable symptoms; an unanswered question must remain missing. Required approvals and staff training are complete, but the new forms have not been deployed. The release decision should be:

Accepted Answer

Correct and retest the handling of unanswered questions before authorizing deployment.

Answer

Deploy with queries for zero responses at the next monitoring visit.

Answer

Release after the vendor confirms successful software installation.

Answer

Require a full independent platform audit rather than retesting the affected function.

Question 10

After several missed activation dates, a regional lead tells the project manager, 'We understand the protocol, but our site leads will not contradict the senior director in an open call.' The dates had been accepted without discussion of local staffing. What adjustment would make the next multinational planning cycle more reliable?

Accepted Answer

Obtain site capacity estimates privately in advance, then confirm achievable dates and owners together.

Answer

Have regional directors commit to dates for their sites before reviewing local capacity.

Answer

Require recorded yes-or-no commitments from site leads during the senior director's call.

Answer

Use the fastest site's activation schedule as the shared target and review exceptions after the first missed milestone.

Free ACRP-PM Practice Questions

Domain 1: Ethical and Participant Safety Considerations 10% of exam

Question 1

Domain 2: Regulatory Affairs 10% of exam

Question 2

Domain 3: Clinical Trial Operations 25% of exam

Question 3

Question 4

Question 5

Domain 4: Study Management 30% of exam

Question 6

Question 7

Domain 5: Scientific Concepts and Research Design 10% of exam

Question 8

Domain 6: Business Management, Leadership, and Professionalism 15% of exam

Question 9

Question 10

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