CCRA® — Certified Clinical Research Associate — Questions and Answers

Question 1: During a pre-study site evaluation visit, the CRA assesses several factors. Which finding would most likely lead the sponsor to REJECT a site?

The site lacks sufficient staff and patient population to meet enrollment targets (Correct answer)
The investigator's delegation log is not yet prepared
The site has conducted only two prior clinical trials
The site's pharmacy stores investigational product in a separate area

Correct answer: The site lacks sufficient staff and patient population to meet enrollment targets

Insufficient patient population or staffing capacity directly threatens the feasibility of completing the trial and is grounds for not selecting a site.

Question 2: Which document type serves as the definitive guide for CRAs on how to perform site visits for a specific trial?

Site Initiation Checklist
Investigator Brochure
Monitoring Plan (Correct answer)
Clinical Study Report

Correct answer: Monitoring Plan

The Monitoring Plan specifies the monitoring strategy, methodology, responsibilities, and procedures to be followed during trial monitoring visits.

Question 3: A 'Competent Authority' in the context of EU clinical trial regulations refers to:

The sponsor's medical monitor
The CRO project manager
A national regulatory body such as the MHRA or BfArM (Correct answer)
The IRB or Ethics Committee

Correct answer: A national regulatory body such as the MHRA or BfArM

A Competent Authority is the national regulatory agency responsible for authorizing clinical trials in a given EU member state, such as the MHRA in the UK or BfArM in Germany.

Question 4: What information must appear on investigational product labels per GCP and regulatory requirements?

Commercial product name and manufacturer address
Only the product name and lot number
Subject name, date of birth, and insurance information
Trial number, protocol ID, subject/dose information, storage conditions, sponsor contact, and the statement 'For Clinical Trial Use Only' (Correct answer)

Correct answer: Trial number, protocol ID, subject/dose information, storage conditions, sponsor contact, and the statement 'For Clinical Trial Use Only'

GCP IP labels must include the clinical trial identification, dosing information, storage requirements, sponsor or manufacturer contact, and the mandatory statement that the product is for investigational use only.

Question 5: In clinical data management, 'edit checks' are used to:

Grant data entry permissions to site coordinators
Send regulatory submissions automatically
Validate data entries against predefined rules to detect out-of-range values, missing data, or logical inconsistencies (Correct answer)
Correct CRF data automatically without site input

Correct answer: Validate data entries against predefined rules to detect out-of-range values, missing data, or logical inconsistencies

Edit checks (or validation rules) are programmed into EDC systems to flag data that is missing, illogical, or outside expected ranges, prompting review or generating queries.

Question 6: According to ICH E6(R2), what is meant by 'essential documents'?

CRFs submitted to the FDA for regulatory review
Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced (Correct answer)
Only the signed informed consent forms from all enrolled subjects
The sponsor's internal SOPs for clinical monitoring

Correct answer: Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced

Essential documents are those that individually and collectively allow evaluation of the trial's conduct and data quality, and they form the Trial Master File.

Question 7: Which regulation requires sponsors to promptly review all information relevant to the safety of the investigational drug received from any source?

45 CFR 46.111
21 CFR 50.25
21 CFR 312.32 (Correct answer)
21 CFR 56.107

Correct answer: 21 CFR 312.32

21 CFR 312.32 specifically governs IND safety reports and requires sponsors to review all safety information and report serious unexpected adverse drug reactions.

Question 8: In electronic clinical trials, 21 CFR Part 11 governs:

The format of IND application submissions
The IRB review process for online-recruited subjects
The use of electronic records and electronic signatures, ensuring they are trustworthy and equivalent to paper records (Correct answer)
The clinical pharmacology requirements for investigational drugs

Correct answer: The use of electronic records and electronic signatures, ensuring they are trustworthy and equivalent to paper records

21 CFR Part 11 establishes FDA requirements for electronic records and signatures to be considered reliable, trustworthy, and equivalent to their paper counterparts, covering audit trails, access controls, and validation.

Question 9: A CRA discovers that a site has been using an expired version of the informed consent form. What is the MOST immediate action?

Halt all trial procedures at the site
Document the finding and require re-consent using the current IRB-approved form (Correct answer)
Submit a serious breach report to the IRB without sponsor involvement
Terminate the investigator immediately

Correct answer: Document the finding and require re-consent using the current IRB-approved form

The CRA must document the deviation and work with the site to re-consent affected subjects using the current approved form, while reporting to the sponsor per the monitoring plan.

Question 10: When a protocol amendment requires IRB approval before implementation, who is responsible for ensuring the amendment is approved prior to implementation at the site?

The CRO
The Sponsor (Correct answer)
The Principal Investigator
The IRB Chair

Correct answer: The Sponsor

The sponsor is responsible for submitting protocol amendments to the FDA and ensuring IRB approval is in place before the amended protocol is implemented at investigational sites.

Question 11: What does 'query resolution' involve in clinical data management?

Resolving IRB approval queries from site staff
Resolving financial payment disputes between sponsor and sites
Identifying, clarifying, and correcting data discrepancies or missing data in CRFs through a formal communication process (Correct answer)
Answering protocol questions from investigators

Correct answer: Identifying, clarifying, and correcting data discrepancies or missing data in CRFs through a formal communication process

Query resolution is the process by which data managers or CRAs flag data issues in the CRF/EDC, sites investigate and correct the data, and the resolution is documented with an explanation.

Question 12: What qualifies as a 'source document' in a clinical trial?

The protocol and amendments only
Electronic data capture system printouts only
Original records and certified copies of original information including medical records, lab reports, and subject diaries (Correct answer)
Only the Case Report Form (CRF)

Correct answer: Original records and certified copies of original information including medical records, lab reports, and subject diaries

Source documents are original records from which subject data are first captured, including hospital records, clinic charts, laboratory notes, diaries, pharmacy records, and imaging results.

Question 13: The 15-day reporting clock for an expedited IND safety report begins when:

The subject reports symptoms to the site staff
The sponsor first receives minimum valid safety information about the SUSAR (Correct answer)
The CRA documents the event in the monitoring report
The IRB is notified of the event

Correct answer: The sponsor first receives minimum valid safety information about the SUSAR

The 15-calendar-day regulatory reporting clock starts when the sponsor receives the minimum information required for a valid case (identifiable patient, reporter, suspect drug, and adverse event).

Question 14: Which element is NOT required to be included in an informed consent form according to 21 CFR Part 50.25?

The expected duration of the subject's participation
A statement that participation is voluntary
A description of foreseeable risks or discomforts
The subject's social security number (Correct answer)

Correct answer: The subject's social security number

21 CFR 50.25 lists required ICF elements, and a subject's social security number is not among them; collecting it would be a privacy concern.

Question 15: What is the purpose of investigational product (IP) accountability at a clinical trial site?

To monitor competitive product use by subjects
To ensure accurate records of all IP received, dispensed, returned, and destroyed to verify subject compliance and prevent misuse (Correct answer)
To calculate the sponsor's manufacturing costs
To track IP shipment transit times

Correct answer: To ensure accurate records of all IP received, dispensed, returned, and destroyed to verify subject compliance and prevent misuse

IP accountability requires maintaining records showing the disposition of every unit of investigational product to confirm it was used only for trial purposes and that subjects received the correct doses.

Question 16: When the investigator's causality assessment differs from the sponsor's (sponsor considers event related, investigator does not), how should the discrepancy be handled for regulatory reporting?

The investigator's assessment always overrides the sponsor's
Both assessments should be reported, with the sponsor reporting based on the more conservative (related) assessment (Correct answer)
A data safety monitoring board must resolve all discrepancies before reporting
The event does not need to be reported if the investigator disagrees

Correct answer: Both assessments should be reported, with the sponsor reporting based on the more conservative (related) assessment

Regulatory guidance requires that when sponsor and investigator causality assessments differ, both must be documented, and the more conservative (causally related) assessment governs regulatory reporting requirements.

Question 17: Which of the following best describes 'open-label' trial design with respect to investigational product management?

Both subjects and investigators know which treatment is being administered, with no blinding of treatment assignment (Correct answer)
The IP label includes the subject's name publicly
Only the subject is unblinded while the investigator remains blinded
IP is provided with no label or identification

Correct answer: Both subjects and investigators know which treatment is being administered, with no blinding of treatment assignment

In an open-label trial, there is no blinding — both the subject and the site staff know which treatment the subject is receiving, simplifying IP management but introducing potential bias.

Question 18: Which practice best ensures blinding integrity during data management activities?

Unblinding all data before database lock for quality review
Sharing treatment assignments with data managers for context
Limiting access to randomization codes to only those who need them for safety monitoring, with all others remaining blinded (Correct answer)
Allowing site coordinators to access treatment assignment codes in the EDC

Correct answer: Limiting access to randomization codes to only those who need them for safety monitoring, with all others remaining blinded

Maintaining blinding integrity requires strict access controls to randomization codes, ensuring that only authorized personnel (e.g., DSMB members, emergency unblinding team) can access treatment assignments.

Question 19: Which document formally authorizes a site to begin receiving and storing investigational product?

The Clinical Trial Agreement (financial contract)
The Site Initiation Visit report
The CRA's monitoring plan
A confirmed IRB approval letter, signed protocol, and completed 1572, with sponsor confirmation of site activation (Correct answer)

Correct answer: A confirmed IRB approval letter, signed protocol, and completed 1572, with sponsor confirmation of site activation

A site must have all regulatory and contractual requirements in place — including IRB approval, signed protocol and 1572, and sponsor activation confirmation — before IP can be shipped or dispensed.

Question 20: A subject experiences a Serious Adverse Event (SAE) on a Monday. Within what timeframe must the investigator report an unexpected, fatal SAE to the sponsor under ICH E6(R2)?

Within 7 calendar days (Correct answer)
Within 30 calendar days
Within 15 business days
Within 24 hours

Correct answer: Within 7 calendar days

ICH E6(R2) requires investigators to report fatal or life-threatening unexpected SAEs to the sponsor within 7 calendar days of first awareness.

Question 21: When a CRA finds that a site has enrolled a subject who did not meet all inclusion criteria, this is documented as:

A protocol deviation or violation (Correct answer)
An investigational product discrepancy
An adverse event
A serious breach of confidentiality

Correct answer: A protocol deviation or violation

Enrolling a subject who fails to meet inclusion criteria is a protocol deviation (or violation if major), which must be documented, reported to the sponsor, and may require IRB notification.

Question 22: An IP 'expiry date extension' means:

The sponsor has performed additional stability testing and obtained regulatory approval to extend the product's use-by date (Correct answer)
The site can continue using expired IP if no new supplies are available
The protocol enrollment period has been extended
The IRB has approved additional drug use beyond the original period

Correct answer: The sponsor has performed additional stability testing and obtained regulatory approval to extend the product's use-by date

Expiry extensions require new stability data demonstrating the product remains within specifications, followed by updated labeling and regulatory notification where required.

Question 23: Subject diaries used to collect patient-reported outcomes (PROs) are considered:

Source documents, as they represent the original record of subject-reported information (Correct answer)
CRF data only, not source data
Secondary data derived from clinical assessments
Not admissible as evidence in regulatory submissions

Correct answer: Source documents, as they represent the original record of subject-reported information

Subject diaries are source documents because they capture data directly from the subject as the original record, and must be retained according to the same archiving requirements as other source documents.

Question 24: During IP reconciliation at a monitoring visit, the CRA discovers more units were dispensed than accounted for in subject dosing records. The FIRST action is to:

Investigate the discrepancy with site staff and document findings; notify the sponsor if unresolved (Correct answer)
Assume it is a counting error and move on
Report the site to the FDA immediately
Destroy the excess IP immediately

Correct answer: Investigate the discrepancy with site staff and document findings; notify the sponsor if unresolved

IP discrepancies must be investigated with site staff to identify the cause; if unexplained, the sponsor must be notified, and depending on severity, regulatory reporting or a for-cause audit may be required.

Question 25: During source data verification (SDV), the CRA finds that a lab value in the CRF was changed without documentation. What does this indicate?

Acceptable site practice to maintain clean data
Evidence of fraud that requires immediate trial suspension
A potential data integrity issue that must be queried and documented (Correct answer)
A minor clerical error that can be verbally corrected

Correct answer: A potential data integrity issue that must be queried and documented

Undocumented CRF changes violate ALCOA+ data integrity principles and must be investigated, queried, and documented in the monitoring report.

Question 26: Risk-Based Monitoring (RBM) focuses monitoring resources primarily on:

Identified critical data and processes with the greatest patient risk potential (Correct answer)
Sites with the highest enrollment numbers
Sites closest geographically to the sponsor
Regulatory submission timelines

Correct answer: Identified critical data and processes with the greatest patient risk potential

RBM, as endorsed by ICH E6(R2) and FDA guidance, prioritizes monitoring efforts based on identified risks to subject safety and data integrity rather than routine 100% source data verification.

Question 27: From 1932 until 1972, the Tuskegee Syphilis Study was conducted.

No
Yes (Correct answer)

Correct answer: Yes

Yes, the infamous Tuskegee Syphilis Study was indeed conducted from 1932 until 1972 by the U.S. Public Health Service. This study observed the natural progression of untreated syphilis in African American men without their informed consent or offering them available treatment. It stands as a profound example of unethical research, leading to significant reforms in human subject protection and research ethics.

Question 28: Site staff may not open or break the blind of randomization codes except:

When medically necessary for subject safety (e.g., medical emergency) following the pre-defined emergency unblinding procedure (Correct answer)
When the CRA requests unblinding during a monitoring visit
When a subject requests to know their treatment assignment
After enrollment of the first 10 subjects for interim safety review

Correct answer: When medically necessary for subject safety (e.g., medical emergency) following the pre-defined emergency unblinding procedure

Emergency unblinding is permitted only when knowledge of treatment is medically necessary to protect the subject, and must follow a documented procedure with notification to the sponsor.

Question 29: Under ICH E6(R2), what is the minimum content required in a monitoring visit report?

List of all subjects enrolled and their randomization codes
Enrollment numbers only
Date of visit, site visited, CRA name, findings, deviations, and follow-up actions (Correct answer)
Protocol version and IRB approval number

Correct answer: Date of visit, site visited, CRA name, findings, deviations, and follow-up actions

ICH E6(R2) requires monitoring reports to capture the visit date, site, monitor identity, findings, deviations, and any required follow-up actions.

Question 30: A 'temperature excursion' for investigational product occurs when:

The IP expiration date passes without disposal
IP storage conditions deviate outside the protocol-specified temperature range (Correct answer)
The IP dispensing log shows missing entries
The IP is shipped to an unapproved country

Correct answer: IP storage conditions deviate outside the protocol-specified temperature range

A temperature excursion is when IP is exposed to temperatures outside the specified storage range; the sponsor's medical/quality team must evaluate whether the affected IP remains usable.

CCRA® — Certified Clinical Research Associate

The CCRA® credential, offered by ACRP, validates the knowledge and skills of clinical research associates who monitor clinical trials to ensure GCP compliance, participant safety, data integrity, and regulatory adherence across all phases of drug and device development.

Questions

35 min

Time Limit

70%

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These practice questions were written with AI tools. They are not real exam questions. Exam facts are checked against the official sources listed below. Not reviewed by a subject-matter expert. Editorial policy

Sources & references

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acrpnet.org — Registration deadline, eligibility, fees, exam format, score release, test dates, time limit, score validity, registration, retake fee · verified Nov 2026
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