Certified Clinical Research Associate Flashcards

During a routine monitoring visit, the CRA discovers that the site has been enrolling subjects who do not meet the inclusion criteria. What is the FIRST action the CRA should take?

Answer: Document the finding and discuss it with the investigator during the visit

The CRA should document the protocol deviation and discuss it with the investigator to understand the root cause before escalating per the monitoring plan.

Which ICH E6(R2) principle requires that each individual involved in conducting a trial should be qualified by education, training, and experience?

Answer: Principle 3 — qualified personnel

ICH E6(R2) Principle 3 specifies that all trial personnel must be qualified by education, training, and experience to perform their tasks.

A subject's source document shows a glucose value of 450 mg/dL, but the CRF records 45 mg/dL. How should this discrepancy be handled?

Answer: Issue a data query to the site to correct the CRF entry with a documented explanation

Transcription errors between source documents and CRFs must be resolved through a formal data query so the correction is auditable.

Under FDA 21 CFR Part 312, the sponsor must notify the FDA of an IND safety report (IND Safety Report) within how many calendar days for unexpected fatal or life-threatening SUSARs?

Answer: 7 calendar days

Fatal or life-threatening unexpected serious adverse reactions must be reported to the FDA within 7 calendar days of the sponsor's first knowledge.

Which document is considered the primary source for verifying that informed consent was obtained before any study procedures were performed?

Answer: The signed and dated informed consent form

The signed and dated informed consent form is the primary document confirming that consent was obtained prior to study participation.

A CRA is reviewing the drug accountability log and notices that the quantity of investigational product dispensed does not reconcile with what subjects received. What should the CRA do?

Answer: Flag the discrepancy, discuss with the pharmacist or site coordinator, and document in the monitoring report

Drug accountability discrepancies must be investigated, discussed with site staff, and documented in the monitoring report to ensure chain of custody.

When must the CRA ensure that the Trial Master File (TMF) is set up and accessible?

Answer: Before the trial begins and maintained throughout the trial

ICH E6(R2) requires the TMF to be established before the trial commences and maintained throughout the trial and post-trial period.