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

To verify the site's financial records

Answer

To train site staff on the protocol

Answer

To audit the sponsor's clinical database

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

Once at the beginning and once at the end of the trial

Answer

Monthly, as specified by regulation

Answer

Only when the site reports a serious adverse event

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

Ignore it if it does not affect subject safety

Answer

Close the site immediately without discussion

Answer

Wait until the next monitoring visit to address it

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 visit to assess site feasibility before the trial begins

Answer

A visit to close out the site at the end of the trial

Answer

A routine monitoring visit during the enrollment phase

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

Only the pharmacist is responsible for drug accountability

Answer

The monitor only needs to count unused drug at the end of the trial

Answer

Drug accountability is the sponsor's sole responsibility

Question 6

What is the difference between triggered and routine monitoring visits?

Accepted Answer

Routine visits are scheduled per the monitoring plan; triggered visits are unscheduled visits prompted by specific concerns or events

Answer

There is no difference; all visits are the same

Answer

Triggered visits are only conducted by auditors, not monitors

Answer

Routine visits are only for data collection while triggered visits are for regulatory inspections