CCRC Exam Flashcards

Q: What's on the CCRC exam?

The CCRC exam has 125 multiple-choice questions (100 scored, 25 unscored pretest items) across six domains: Scientific Concepts & Research Design (8%), Ethical & Participant Safety (19%), Product Development & Regulation (13%), Clinical Trial Operations/GCPs (23%), Study & Site Management (22%), and Data Management & Informatics (15%). You have 180 minutes (3 hours) to complete it.

Q: What is the CCRC passing score?

ACRP uses a scaled score of 600 to pass and does not publish a raw percentage equivalent or overall pass rate. Score reports include pass/fail plus domain-level performance feedback so candidates can see relative strengths and weaknesses.

Q: How much does the CCRC exam cost?

2026 fees are tiered by ACRP membership and registration timing: as low as $435 for early-bird ACRP members up to $600 for regular nonmember registration. Retake attempts are charged at the same tiered fee structure as an initial attempt.

Q: What happens if I fail the CCRC exam?

You must wait at least 60 days after your original test appointment (or until the next testing window) before retesting. If the retake attempt also doesn't pass, ACRP requires a completely new application and payment of all current fees rather than a further fixed waiting period — there is no distinct 'third attempt' track.

Q: What eligibility do I need to sit for the CCRC?

Candidates need 3,000 verified hours of clinical research coordinator work experience under a paid employment agreement. Up to 1,500 of those hours can be waived for candidates who complete an ACRP-approved clinical research education program or hold an active ACRP certification. No firm sponsorship is required — candidates register and submit experience verification themselves.

Q: Is the CCRC exam based on ICH GCP or U.S. 21 CFR regulations?

ACRP's Exam Content Outline is referenced specifically to ICH guidelines — E6(R3) (effective July 15, 2026, replacing E6(R2)), E2A, E8(R1), E9/E9(R1), E11(R1) — plus the Declaration of Helsinki, not to numbered CFR sections. In practice, U.S. sites still operate under FDA rules like 21 CFR Parts 50 (informed consent), 56 (IRBs), 312 (IND), and 812 (IDE) that implement the same GCP principles domestically.

Question 1

What must a clinical trial protocol define, per ICH GCP?

Accepted Answer

The protocol is the master document defining the trial's rationale, objectives, design, methodology, statistical plan, and organization. Site staff who deviate from it without prior IRB/sponsor approval create a protocol deviation or violation.

Question 2

Investigator's Brochure (IB) — what is it for?

Accepted Answer

A compilation of the clinical and nonclinical data on the investigational product. Coordinators use it to judge whether an adverse event is 'expected' (listed in the IB) or 'unexpected' (not listed), which drives expedited reporting timelines.

Question 3

Primary endpoint vs. secondary endpoint

Accepted Answer

The primary endpoint is the single pre-specified outcome that answers the study's main question and determines the sample-size/power calculation. Secondary endpoints add supportive evidence but do not drive that calculation.

Question 4

Why do sites track 'screen fail rate'?

Accepted Answer

Screen fail rate is the percentage of prescreened candidates who don't meet eligibility criteria and never enroll. Sites use it to size the recruitment funnel large enough to hit the enrollment target within the study timeline.

Question 5

AE vs. SAE — what turns an adverse event 'serious'?

Accepted Answer

An AE is any untoward medical occurrence in a subject, regardless of severity. It becomes an SAE only if it results in death, is life-threatening, requires/prolongs hospitalization, causes persistent disability, or is a congenital anomaly — seriousness is about outcome criteria, not intensity.

Question 6

SUSAR — define it and give the two ICH E2A expedited-reporting clocks.

Accepted Answer

A SUSAR is a Suspected Unexpected Serious Adverse Reaction — serious, not listed in the current Investigator's Brochure, with a reasonable causal link to the investigational product. Fatal/life-threatening SUSARs must be reported within 7 calendar days (with 8-day follow-up); all other SUSARs within 15 calendar days.

Question 7

What must be documented before a subject undergoes ANY protocol-specific procedure?

Accepted Answer

Informed consent must be obtained and documented BEFORE any study procedure, including screening tests that aren't part of the subject's standard-of-care. Consent obtained after the fact is a GCP violation, not just a deviation.

Question 8

Name the required elements of an informed consent form.

Accepted Answer

Purpose of the research, expected duration, procedures, foreseeable risks/discomforts, expected benefits, alternative treatments, confidentiality provisions, and a statement that participation is voluntary with the right to withdraw at any time without penalty.

Question 9

When must a subject be re-consented?

Accepted Answer

Whenever new information emerges that could affect a subject's willingness to continue (e.g., a protocol amendment, new safety signal, or added procedure) — the coordinator must update the ICF and re-consent before the change takes effect, not after.

Question 10

How is consent obtained from a participant who cannot read?

Accepted Answer

The consent discussion is conducted orally in the presence of an impartial witness, who signs and dates the consent form attesting that the information was accurately explained and the subject appeared to understand and voluntarily agree.

Question 11

Assent vs. consent in pediatric research

Accepted Answer

Assent is the child's own age-appropriate agreement to participate; consent is the legal permission given by a parent or legally authorized representative (LAR). Both are typically required — a child's dissent can override parental consent in most protocols.

Question 12

What are the Belmont Report's three ethical principles?

Accepted Answer

Respect for persons (autonomy and protection of those with diminished autonomy), beneficence (maximize benefit, minimize harm), and justice (fair distribution of research burdens and benefits) — the 1979 U.S. foundation for human-subjects protection.

Question 13

Declaration of Helsinki — what is it?

Accepted Answer

A World Medical Association statement of ethical principles for medical research involving human subjects, first adopted in 1964 and periodically revised. ICH GCP explicitly grounds its ethical principles in this declaration.

Question 14

A coordinator suspects data fabrication at their own site — what's the obligation?

Accepted Answer

Report suspected fraud or misconduct promptly through the site's/sponsor's escalation channel; concealing or failing to report it is itself an ethical and GCP violation, separate from whatever the original misconduct was.

Question 15

Order the four clinical trial phases by purpose.

Accepted Answer

Phase I: safety in a small group (often healthy volunteers). Phase II: dose-finding and preliminary efficacy. Phase III: large confirmatory efficacy/safety trial supporting approval. Phase IV: post-marketing surveillance after the product is approved.

Question 16

IND vs. IDE

Accepted Answer

An IND (Investigational New Drug application) is the FDA pathway that permits human trials of a drug or biologic. An IDE (Investigational Device Exemption) is the separate FDA pathway for investigational medical devices — same underlying safeguard, different product category.

Question 17

IRB/IEC — role and composition

Accepted Answer

An independent body of medical, scientific, and non-scientific members that reviews and must approve the protocol, informed consent form, and amendments before a trial starts, safeguarding participants' rights, safety, and wellbeing throughout the study.

Question 18

Can a site implement a protocol amendment before IRB/IEC approval?

Accepted Answer

No — amendments require prior IRB/IEC approval before implementation, with one exception: changes needed to eliminate an immediate hazard to subjects may be implemented right away and reported to the IRB/IEC afterward.

Question 19

Audit vs. inspection

Accepted Answer

An audit is a sponsor-initiated internal quality-assurance review of trial conduct and data. An inspection is a regulatory authority's official, legally-empowered review of the same — audits are internal QA; inspections carry enforcement authority.

Question 20

Why must a trial be registered on a public clinical trial registry?

Accepted Answer

Transparency requirements (e.g., ClinicalTrials.gov in the U.S.) require registration before or shortly after enrollment begins, so regulators, IRBs, and the public can track ongoing research and later verify that results were reported.

Question 21

What is a delegation log and why does it matter?

Accepted Answer

It's the record listing each site staff member and the specific study tasks the investigator has authorized them to perform. A task performed by someone not listed on the log is a GCP finding, even if the person was technically qualified.

Question 22

CAPA — corrective vs. preventive action

Accepted Answer

A corrective action fixes a problem that has already occurred (e.g., retraining after a documentation error); a preventive action addresses a potential problem before it happens (e.g., adding a double-check step). A CAPA plan typically includes both.

Question 23

What does a monitoring visit typically verify?

Accepted Answer

Source data verification (SDV) — that CRF entries match source documents — plus protocol/GCP compliance, IP accountability, and regulatory document currency. Findings are followed up and tracked to resolution before the next visit.

Question 24

Pre-study visit vs. site initiation visit (SIV)

Accepted Answer

A pre-study visit qualifies and selects a site BEFORE it's chosen for the trial. The SIV happens after selection, before enrollment opens, and trains staff on the protocol, procedures, and systems — different visits, different purposes and timing.

Question 25

Can a principal investigator delegate away responsibility for the trial's conduct?

Accepted Answer

No — the PI may delegate specific tasks to qualified, trained staff via the delegation log, but ultimate responsibility for protocol compliance, subject safety, and data integrity at the site remains non-delegable.

Question 26

What does a site evaluate during a feasibility assessment?

Accepted Answer

Whether it realistically has the patient population, qualified staff, equipment, and time to successfully conduct the study as designed — done before agreeing to participate, to avoid under-enrollment or non-compliance later.

Question 27

Sponsor vs. CRO vs. regulatory authority — who does what?

Accepted Answer

The sponsor funds the trial, supplies the investigational product, and holds ultimate accountability. A CRO (Contract Research Organization) may be delegated specific sponsor duties like monitoring, but the sponsor remains accountable. The regulatory authority reviews/approves the trial and can inspect or halt it.

Question 28

What happens at a study closeout visit?

Accepted Answer

The monitor reconciles investigational product accountability, resolves outstanding data queries, confirms essential documents are complete, and verifies proper record archiving before the site's role in the trial formally ends.

Question 29

Protocol deviation vs. protocol amendment

Accepted Answer

A deviation is an unplanned, unapproved departure from the protocol discovered after the fact and then reported. An amendment is a planned protocol change that receives IRB/IEC approval BEFORE it takes effect — reactive versus proactive.

Question 30

A coordinator discovers a serious, willful protocol violation — what's required?

Accepted Answer

Notify the sponsor and IRB/IEC promptly with full documentation; serious violations (unlike minor deviations) can trigger a formal CAPA, additional monitoring, or in severe cases suspension of the site's participation.

Question 31

Why must site staff training be documented, not just completed?

Accepted Answer

Monitors and auditors verify competency to perform delegated tasks through training records/logs — a task performed without a documented, current training record is treated as if the person weren't qualified, regardless of actual skill.

Question 32

What must happen before site staff can perform any delegated protocol task?

Accepted Answer

The investigator must have added them to the delegation log with appropriate qualifications and completed protocol-specific training — sequence matters: training and delegation come before task performance, not after.

Question 33

What does an investigational product (IP) accountability log track?

Accepted Answer

Every unit of IP from receipt through dispensing, return, or destruction — quantities in, quantities out, to whom, and when — so the sponsor can reconcile exactly what happened to every dose supplied to the site.

Question 34

A refrigerator holding IP suffers a temperature excursion overnight — first three steps?

Accepted Answer

Quarantine the affected product immediately (stop using or dispensing it), document the exact time/duration/temperature range of the excursion, then notify the sponsor and await their stability determination before resuming use or destroying it.

Question 35

What must appear on investigational product labeling?

Accepted Answer

At minimum: protocol/study identifier and storage conditions, and (for blinded studies) a randomization code rather than the actual treatment name — labeling must never inadvertently reveal a subject's treatment assignment in a blinded trial.

Question 36

IP shipment vs. IP storage responsibilities

Accepted Answer

Shipment requires verified chain-of-custody and, for temperature-sensitive product, continuous monitoring devices with the shipment. Storage requires the site to maintain and log the specified conditions (e.g., temperature range) continuously once product arrives on site.

Question 37

What should a clinical trial site budget specify?

Accepted Answer

Per-subject visit and procedure costs, overhead/administrative fees, and a payment schedule typically tied to milestones like enrollment, visit completion, or data lock — captured in the site's contract with the sponsor/CRO.

Question 38

Why are lab specimen handling procedures (centrifuge, freezing, shipment) protocol-specified?

Accepted Answer

Improper collection, processing, or storage can degrade a sample before it's analyzed, invalidating the result — coordinators must follow the lab manual exactly so specimen integrity supports valid, usable data.

Question 39

How is subject compliance with the study regimen typically assessed?

Accepted Answer

Pill counts, subject diaries, and sometimes drug-level assays or device data logs — used to confirm the participant is actually following the protocol-required dosing or procedure schedule between visits.

Question 40

A subject misses two consecutive dosing visits — what is the coordinator's non-compliance responsibility?

Accepted Answer

Document the missed visits, assess whether the gap affects subject safety or data validity, follow the protocol's discontinuation/deviation procedure, and report to the sponsor/IRB if required by that protocol's non-compliance management plan.

Question 41

What does 'vendor management' cover at a research site?

Accepted Answer

Coordinating and overseeing third parties the trial depends on — central labs, IRT/IWRS providers, imaging cores, specialty couriers — confirming their services meet contract terms and protocol specifications, since their errors become the site's problem.

Question 42

Why does a mis-calibrated piece of study equipment matter even if it 'still works'?

Accepted Answer

Any data generated by equipment outside its calibration/maintenance schedule is considered unreliable — the readings can't be trusted as accurate, which can invalidate the endpoints or safety assessments that depended on them.

Question 43

What is 'data lock' and why do coordinators track project timelines toward it?

Accepted Answer

Data lock is the point when the trial database is finalized and no further changes are permitted. Coordinators track enrollment, recruitment/retention, and query-resolution timelines because unresolved items delay lock and the overall trial schedule.

Question 44

eCRF/CRF vs. source documents — which one wins if they disagree?

Accepted Answer

Source documents (the original clinical records) always take precedence — the CRF is only a transcription of the source. Any CRF entry must be traceable back to and verifiable against the original source record.

Question 45

What is a 'data query' and what must a coordinator do with one?

Accepted Answer

A flag raised (usually by a monitor or data manager) when a CRF entry is inconsistent, missing, or conflicts with source data. The coordinator must investigate against the source and resolve — correct, clarify, or confirm — before the item can be closed.

Question 46

IWRS/IRT — what does this system manage?

Accepted Answer

The Interactive Web/Voice Response System (IWRS/IRT) manages randomization assignment and real-time investigational product inventory at the site, ensuring the right product/dose is dispensed and stock levels trigger resupply automatically.

Question 47

What are 'Essential Documents' and where do they live?

Accepted Answer

The set of records that individually and collectively permit evaluation of trial conduct and data quality (e.g., signed protocol, IRB approvals, signed consent forms, delegation log) — collected and maintained in the Trial Master File (TMF), paper or electronic.

Question 48

Who decides how long a site must retain trial records — regulators or the sponsor?

Accepted Answer

Both set a floor: regulatory requirements set a minimum retention period, but the sponsor's contract can require a longer retention period than the regulatory minimum. Sites must follow whichever requirement is longer, and destruction requires sponsor authorization.

Question 49

SDV vs. SDR

Accepted Answer

Source Data Verification (SDV) compares a specific CRF entry against the source document to confirm they match. Source Data Review (SDR) is the broader review of the source record itself for completeness and quality, independent of any CRF entry.

Question 50

What does ALCOA+ stand for, and what is it used to judge?

Accepted Answer

Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available — the nine traits regulators and auditors use to judge whether study documentation and data can be trusted as reliable source evidence.

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