SOCRA CCRP Monitor 2

Question 1

What is the primary purpose of source data verification (SDV) during a monitoring visit?

Accepted Answer

To ensure that data recorded in the CRF accurately reflects the source documents

Answer

Source data verification is the process by which the monitor compares CRF entries against original source documents to ensure accuracy, completeness, and consistency of reported data.

Question 2

According to ICH-GCP, how often should a monitor visit a clinical trial site?

Accepted Answer

With a frequency determined by the monitoring plan based on trial characteristics

Answer

ICH-GCP does not mandate a specific visit frequency. Instead, the monitoring plan should define visit frequency based on factors such as trial complexity, enrollment rate, data quality, and site experience.

Question 3

What should a monitor do if they discover a serious protocol deviation during a site visit?

Accepted Answer

Document the deviation, discuss it with the investigator, and report it to the sponsor promptly

Answer

When a serious protocol deviation is discovered, the monitor must document it in the monitoring report, discuss it with the investigator to determine the cause and implement corrective action, and promptly report it to the sponsor.

Question 4

What is a site initiation visit (SIV) and when does it occur?

Accepted Answer

A visit conducted after regulatory approval to train site staff and ensure readiness to enroll subjects

Answer

A site initiation visit occurs after all regulatory approvals are in place and before the first subject is enrolled. Its purpose is to train site staff, review the protocol, verify site readiness, and ensure all essential documents are in place.

Question 5

What is the monitor's responsibility regarding investigational product accountability at a site?

Accepted Answer

The monitor must verify that the IP is properly stored, dispensed, and accounted for according to the protocol

Answer

The monitor is responsible for verifying at each visit that the investigational product is properly stored at required conditions, dispensed correctly according to the protocol, accurately documented on accountability logs, and that unused product is handled appropriately.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Monitor 2