CCRC - Certified Clinical Research Coordinator Clinical Trial Operations (GCP) Questions and Answers

Question 1

A Clinical Research Coordinator (CRC) receives a shipment of investigational product that must be stored between 2-8°C.
The temperature monitoring device packed with the shipment indicates a temperature of 10°C for the last four hours of transit.
What is the most appropriate immediate action for the CRC?

Accepted Answer

Quarantine the shipment, document the temperature excursion, and notify the sponsor for instructions.

Answer

Dispense the drug to participants immediately to avoid waste.

Answer

Place the drug in the proper refrigerator and use it once it has cooled to the correct temperature range.

Answer

Return the shipment directly to the sponsor without notifying anyone at the site.

Question 2

According to ICH GCP E6 (R2), which document is specifically maintained at the trial site to record all individuals who have been delegated significant trial-related duties by the Principal Investigator (PI)?

Accepted Answer

Delegation of Authority (DoA) Log

Answer

The protocol signature page

Answer

Form FDA 1572

Answer

Financial Disclosure Form

Question 3

A monitor is conducting source data verification (SDV) and notes that a blood pressure reading of '130/85' recorded in the electronic Case Report Form (eCRF) does not match the value of '135/80' written in the participant's original, signed progress note. This discrepancy is a violation of which core ALCOA-C principle of good documentation practice?

Accepted Answer

Accurate

Answer

Contemporaneous

Answer

Legible

Answer

Attributable

Question 4

A study participant is scheduled for their Week 4 visit, which has a protocol-specified visit window of +/- 3 days. The participant calls with a personal emergency and is unable to come to the clinic until 7 days after the target date, which is outside the visit window. How should the CRC classify and handle this occurrence?

Accepted Answer

As a protocol deviation that must be documented and reported according to site and sponsor procedures.

Answer

As a serious adverse event (SAE) requiring immediate reporting.

Answer

As a minor issue that does not require documentation since the participant eventually completed the visit.

Answer

As a critical protocol violation that requires the participant to be immediately withdrawn from the study.

Question 5

Which of the following is the primary purpose of a Site Initiation Visit (SIV) conducted by the sponsor or a Contract Research Organization (CRO)?

Accepted Answer

To provide comprehensive, protocol-specific training to the site staff and verify readiness before the first participant is enrolled.

Answer

To review and verify all participant data collected since the last monitoring visit.

Answer

To officially close out the study site and ensure all essential documents are properly archived.

Answer

To obtain informed consent from the first group of potential study participants.

Question 6

By signing the Form FDA 1572, a Principal Investigator (PI) makes a binding commitment to the FDA to perform which of the following actions?

Accepted Answer

Ensure the investigation is conducted according to the current protocol and to personally supervise or conduct the investigation.

Answer

Guarantee that a minimum number of participants will be enrolled at the site.

Answer

Personally conduct every single study-related procedure for all enrolled participants.

Answer

Submit all study data directly to a peer-reviewed medical journal within six months of study completion.