Monitor Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Monitor flashcards as text
What is the primary purpose of source data verification (SDV) during a monitoring visit?
Answer: To ensure that data recorded in the CRF accurately reflects the source documents
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.
According to ICH-GCP, how often should a monitor visit a clinical trial site?
Answer: With a frequency determined by the monitoring plan based on trial characteristics
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.
What should a monitor do if they discover a serious protocol deviation during a site visit?
Answer: Document the deviation, discuss it with the investigator, and report it to the sponsor promptly
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.
What is a site initiation visit (SIV) and when does it occur?
Answer: A visit conducted after regulatory approval to train site staff and ensure readiness to enroll subjects
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.
What is the monitor's responsibility regarding investigational product accountability at a site?
Answer: The monitor must verify that the IP is properly stored, dispensed, and accounted for according to the protocol
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.
What is the difference between triggered and routine monitoring visits?
Answer: Routine visits are scheduled per the monitoring plan; triggered visits are unscheduled visits prompted by specific concerns or events
Routine monitoring visits are pre-planned visits scheduled according to the monitoring plan, while triggered visits are unscheduled visits initiated in response to specific events such as safety signals, high deviation rates, or enrollment concerns.