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Free CCRP Practice Questions

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

These 10 free CCRP questions are organized by exam domain, so you can see how each part of the Certified Clinical Research Professional blueprint is tested. Reveal the answer and explanation under each question.

Domain 1: Research Study Start-Up 40% of exam

Question 1

During an internal audit, a reviewer discovers that the informed consent form used at one site is missing several required elements. Which of the following is one of the eight basic elements of informed consent required under federal regulations?

  1. The approximate number of subjects expected to participate in the study
  2. A description of any additional costs to the subject that may result from participation
  3. A statement that the study involves research, including an explanation of the purposes and expected duration of participation
  4. The circumstances under which the subject's participation may be terminated by the investigator
Show answer & explanation

Correct answer: C - A statement that the study involves research, including an explanation of the purposes and expected duration of participation

Question 2

A subject who speaks only Mandarin is being enrolled at an English-speaking research site. The site uses the short form consent process with a Mandarin-speaking witness present. After the consent discussion, who must sign the written English-language summary of the study?

  1. The subject, the witness, and the person who obtained consent
  2. The witness and the person who obtained consent, but not the subject
  3. The subject and the witness, but not the person who obtained consent
  4. Only the person who obtained consent, because the summary is in English
Show answer & explanation

Correct answer: B - The witness and the person who obtained consent, but not the subject

Question 3

A newly formed Institutional Review Board at a community hospital is being evaluated for regulatory compliance. The board consists of six members: four physicians, one registered nurse, and one community advocate with no institutional affiliation. According to both FDA regulations and ICH-GCP, which requirement is this IRB failing to meet?

  1. The IRB does not include a member whose primary concerns are in non-scientific areas
  2. The IRB does not include at least one member who is not otherwise affiliated with the institution
  3. The IRB does not meet the minimum membership requirement of seven members
  4. The IRB does not include a member who is a licensed pharmacist
Show answer & explanation

Correct answer: A - The IRB does not include a member whose primary concerns are in non-scientific areas

Question 4

Before an IND study begins, the principal investigator completes the required FDA documentation. During a pre-study visit, the monitor reviews a form that lists the investigator's qualifications, the names of sub-investigators, the name and address of the IRB, and the investigator's commitment to comply with applicable regulations. Which FDA form is the monitor reviewing?

  1. FDA Form 3454 - Certification: Financial Interests and Arrangements of Clinical Investigators
  2. FDA Form 1572 - Statement of Investigator
  3. FDA Form 3455 - Disclosure: Financial Interests and Arrangements of Clinical Investigators
  4. FDA Form 1571 - Investigational New Drug Application Cover Sheet
Show answer & explanation

Correct answer: B - FDA Form 1572 - Statement of Investigator

Question 5

A medical device company is preparing to conduct a clinical study of a new implantable cardiac pacemaker. Under FDA regulations, this device meets the definition of a significant risk device. What regulatory pathway must the sponsor follow before beginning the study?

  1. Submit an Investigational Device Exemption application to the FDA and obtain both FDA approval and IRB approval before enrolling subjects
  2. Obtain IRB approval only, because implantable devices are automatically exempt from FDA submission requirements
  3. Submit a Premarket Approval application to the FDA, because all implantable devices require PMA before any clinical testing
  4. Register the study on ClinicalTrials.gov within 21 days and notify the IRB, but no FDA submission is required for devices
Show answer & explanation

Correct answer: A - Submit an Investigational Device Exemption application to the FDA and obtain both FDA approval and IRB approval before enrolling subjects

Domain 2: Research Study Implementation 50% of exam

Question 6

A 54-year-old subject enrolled in a Phase 3 IND study is admitted to the hospital for observation after experiencing severe dizziness and syncope during a routine study visit. The event resolves within 48 hours with no lasting effects. How should this event be classified?

  1. Adverse Event only, because the subject recovered fully without lasting effects
  2. Serious Adverse Event, because inpatient hospitalization is a seriousness criterion regardless of outcome
  3. Adverse Drug Reaction, because the event occurred during a study visit and is likely drug-related
  4. Unanticipated Adverse Device Effect, because the event was not expected based on the protocol
Show answer & explanation

Correct answer: B - Serious Adverse Event, because inpatient hospitalization is a seriousness criterion regardless of outcome

Question 7

A sponsor receives notification that a subject in one of its IND studies died unexpectedly from cardiac arrest. The event is not listed in the Investigator's Brochure and is assessed as possibly related to the investigational drug. Within what timeframe must the sponsor submit an IND safety report to the FDA?

  1. Within 15 calendar days of the sponsor first receiving the information
  2. Within 7 calendar days of the sponsor first receiving the information, with a follow-up report within 15 calendar days
  3. Within 10 working days of the sponsor first receiving the information
  4. Within 24 hours of the sponsor first receiving the information
Show answer & explanation

Correct answer: B - Within 7 calendar days of the sponsor first receiving the information, with a follow-up report within 15 calendar days

Question 8

A study coordinator notices that she recorded a subject's blood pressure as "140/90 mmHg" on the case report form, but the source document reads "130/80 mmHg." What is the correct procedure to fix this discrepancy?

  1. Use correction fluid to cover the incorrect entry, then write the correct value above it
  2. Completely blacken the incorrect entry so it cannot be read, then write the correct value next to it
  3. Draw a single line through the incorrect entry, write the correct value nearby, and add her initials, the date, and a brief explanation
  4. Delete the incorrect entry in the electronic system and re-enter the correct value with today's date
Show answer & explanation

Correct answer: C - Draw a single line through the incorrect entry, write the correct value nearby, and add her initials, the date, and a brief explanation

Question 9

During a routine study visit, a coordinator realizes that she drew a pharmacokinetic blood sample 6 hours after dosing instead of the protocol-required 4 hours after dosing. The deviation does not pose any safety risk to the subject. What is the coordinator's MOST appropriate first action?

  1. Amend the protocol to allow a wider sample collection window before notifying anyone
  2. Document the deviation in the source documents and report it to the principal investigator and sponsor per the site's standard operating procedures
  3. Discard the sample and redraw at the correct time point during the subject's next visit
  4. Wait until the next monitoring visit so the monitor can advise on how to handle the situation
Show answer & explanation

Correct answer: B - Document the deviation in the source documents and report it to the principal investigator and sponsor per the site's standard operating procedures

Domain 3: Research Study Closure 10% of exam

Question 10

An IND study has been completed and the sponsor has submitted the data to the FDA in support of a New Drug Application. The NDA is approved. According to federal regulations, what is the minimum period that the clinical investigator must retain all study records after this approval?

  1. 5 years after the date of NDA approval
  2. 3 years after the date the study was completed
  3. 2 years after the date the marketing application is approved
  4. Indefinitely, until the FDA provides written authorization to destroy the records
Show answer & explanation

Correct answer: C - 2 years after the date the marketing application is approved

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