10 exam-style questions with answers and explanations, straight from our 1,030-question bank. Tap an answer to check yourself. When you're ready, take the scored version in the free practice test.
The CCRA exam has 125 questions and runs 3 hours.
These 10 free CCRA questions are organized by exam domain, so you can see how each part of the Certified Clinical Research Associate blueprint is tested. Reveal the answer and explanation under each question.
An enrolling clinician can preview the next treatment assignment before deciding which eligible patient to randomize. The sequence itself is random. The clinician has no subsequent treatment or outcome-assessment role, and participants, treating staff, and endpoint assessors remain blinded. The principal methodological concern is:
Correct answer: C - Selection bias from inadequate allocation concealment.
A trial compares a new antibiotic with standard therapy using clinical cure as the primary outcome. The prespecified noninferiority margin for the difference in cure rates, new minus standard, is -6 percentage points. The primary analysis estimates a difference of -1 point, with a two-sided 95% confidence interval from -4 to +2 points. The protocol uses the lower bound of this interval to assess noninferiority. How should this finding be interpreted?
Correct answer: D - The result supports noninferiority, but does not establish superiority over standard therapy.
After receiving study drug, a participant develops bronchospasm requiring urgent treatment in an emergency department but no inpatient admission. The investigator judges that intervention was necessary to prevent respiratory failure and that a drug relationship is reasonably possible. The applicable reference safety information describes this reaction and its severity. No protocol exception to immediate serious-adverse-event reporting applies. How should the site handle the event?
Correct answer: A - Report an expected SAE to the sponsor immediately, including the investigator's assessment of causality.
A participant enrolled at age 17 with parental permission and assent returns at age 19 for a long-term research visit. The local age of legal consent is 18, and the participant has decision-making capacity. No adult consent has been obtained. The trial's risks and procedures are unchanged. What consent is needed for continued participation?
Correct answer: A - The participant's own legally effective informed consent.
A pending amendment adds an optional pharmacokinetic sample to an existing visit. It does not address an immediate hazard, and the IRB/IEC has not approved it. The site's current approval remains valid, and every required procedure can be completed under the approved protocol. The investigator asks whether next week's visits must be postponed. The CRA should advise the site to:
Correct answer: B - Continue the approved visits without collecting the sample introduced by the amendment.
Three participants at a satellite clinic signed a superseded consent form despite staff completing amendment training. The CRA traces each form to the same set of preassembled screening packets; the electronic master is current. Participant follow-up and deviation reporting have been completed. Which corrective and preventive action plan most directly addresses recurrence?
Correct answer: B - Replace obsolete packets, assign an update owner, and check the next 10 signed forms.
A pharmacy begins a reporting interval with 84 unopened investigational-product kits and no other stock. It receives 36 kits, dispenses 70, and receives 8 unused kits back from participants. No other movements occur. At the monitoring visit, the physical count is 48 unopened kits plus all 8 returned kits. The unopened kits meet release requirements; participant-returned kits cannot be re-dispensed. Which reconciliation finding should the CRA record?
Correct answer: C - Two kits are missing; only the 48 unopened kits may be dispensed.
Refrigerator A records two hours at 11 degrees C; study-drug storage must remain at 2-8 degrees C. Its kits are quarantined pending the sponsor's stability assessment. Refrigerator B holds kits from the same lot but has an independent, continuous in-range temperature record. An unexpired kit in B meets all dispensing requirements and is assigned to today's eligible participant through the approved system. No study-wide hold exists. Which dispensing recommendation is justified?
Correct answer: D - Dispense the assigned kit from refrigerator B while refrigerator A's stock remains quarantined.
An electronic case report form (eCRF) lists an adverse event's onset as 14 May. A clinic note first describes the event on 16 May but does not specify when it began. The participant's first dose was on 15 May. The CRA needs source-supported clarification without steering whether the event is classified as pre-dose or post-dose. Select the most appropriate query.
Correct answer: D - Please verify the onset date and document the information supporting it.
Seven daily symptom reports from one participant share a server receipt timestamp. The device audit trail shows a separate authenticated entry on each scheduled evening, with no later edits. The validated application permits offline capture and preserves original entry timestamps during synchronization. All seven reports were transmitted when connectivity returned. Which conclusion is justified by these records?
Correct answer: C - Contemporaneous offline capture was followed by delayed transmission of the stored reports.
The full bank has 1,020 more CCRA questions with explanations.
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