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Free CCRC Practice Questions

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

Question 1

A subject in a clinical trial develops a severe migraine that resolves within 6 hours without treatment and does not require hospitalization. This event is classified as:

  1. Not an adverse event because it resolved on its own
  2. A non-serious adverse event because 'severe' describes intensity, not seriousness
  3. An adverse drug reaction because it occurred during the trial
  4. A serious adverse event because the migraine was severe
Show answer & explanation

Correct answer: B - A non-serious adverse event because 'severe' describes intensity, not seriousness

Question 2

During a monitoring visit, the monitor discovers that a subject signed the consent form but the consent date is after the date of the first study-specific screening procedure. This represents:

  1. Normal timing as consent can be signed at any visit
  2. An issue only if the subject was harmed by the procedure
  3. A protocol deviation because consent must be documented before any study procedures
  4. Acceptable practice if the subject verbally agreed beforehand
Show answer & explanation

Correct answer: C - A protocol deviation because consent must be documented before any study procedures

Question 3

The PRIMARY difference between an audit and an inspection is:

  1. Audits are mandatory; inspections are voluntary
  2. Audits occur before the study; inspections occur after
  3. Audits focus on safety; inspections focus on efficacy
  4. Audits are sponsor-conducted; inspections are regulatory-conducted
Show answer & explanation

Correct answer: D - Audits are sponsor-conducted; inspections are regulatory-conducted

Question 4

A temperature excursion occurs when the storage temperature goes outside the acceptable range specified in the protocol. The CRC's FIRST action should be:

  1. Document the excursion, quarantine the product, and notify the sponsor
  2. Continue dispensing the drug since brief excursions rarely affect potency
  3. Move the drug to a different storage location immediately
  4. Discard all study drug without consulting the sponsor
Show answer & explanation

Correct answer: A - Document the excursion, quarantine the product, and notify the sponsor

Question 5

According to ICH E6, the investigator should not make any deviations from or changes to the protocol without agreement of the sponsor and prior IRB/IEC approval EXCEPT:

  1. When the deviation is minor and does not affect subject safety or data integrity
  2. When the change involves only administrative or logistical modifications to study procedures
  3. When the alteration is requested by the principal investigator and documented appropriately
  4. When necessary to eliminate an immediate hazard to the trial subjects
Show answer & explanation

Correct answer: D - When necessary to eliminate an immediate hazard to the trial subjects

Question 6

A CRC who is not listed on the DOA log performs informed consent for a study subject. This situation:

  1. Is not a concern since consent was obtained
  2. Represents a protocol deviation
  3. Is acceptable if the CRC is otherwise qualified
  4. Only requires documentation in the training log
Show answer & explanation

Correct answer: B - Represents a protocol deviation

Question 7

A CRC is setting up the regulatory binder (investigator site file) for a new study. Essential documents that must be in the binder BEFORE the clinical phase begins include all of the following EXCEPT:

  1. IRB/IEC approval letter
  2. Investigator's CV and medical license
  3. Signed protocol
  4. Final clinical study report
Show answer & explanation

Correct answer: D - Final clinical study report

Question 8

A CRC uses correction fluid (white-out) to cover an error in the source document and writes the new value over it. This practice:

  1. Is acceptable if the CRC initials and dates the correction with proper documentation
  2. Violates ALCOA+ and GCP because the original entry is obliterated and cannot be recovered
  3. Is acceptable for minor corrections if witnessed by a second qualified person
  4. Is the standard correction method for paper documents in non-regulated environments
Show answer & explanation

Correct answer: B - Violates ALCOA+ and GCP because the original entry is obliterated and cannot be recovered

Question 9

A CRC is calculating the number of subjects to screen based on an anticipated 30% screen failure rate and a target enrollment of 100 subjects. Approximately how many subjects should be screened?

  1. 115
  2. 100
  3. 143
  4. 130
Show answer & explanation

Correct answer: C - 143

Question 10

A fatal, unexpected adverse drug reaction must be reported by the sponsor to the regulatory authority within:

  1. 7 calendar days
  2. 15 calendar days
  3. 24 calendar hours
  4. 30 calendar days
Show answer & explanation

Correct answer: A - 7 calendar days

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