SOCRA CCRP Site Management

Question 1

What is the purpose of a site initiation visit (SIV) in clinical research?

Accepted Answer

To train site staff on the protocol, procedures, and regulatory requirements before study initiation

Answer

To screen the first study subject

Answer

To conduct the first monitoring visit after enrollment begins

Answer

To audit the site's financial records

Question 2

What is a 'delegation log' (also called a 'delegation of authority log') at a clinical trial site?

Accepted Answer

A document identifying each staff member's qualifications and the specific trial tasks they are authorized to perform

Answer

A record of sponsor payments to the site

Answer

A log of protocol deviations delegated to subinvestigators

Answer

A record of IRB meeting attendance

Question 3

What is the role of a Clinical Research Coordinator (CRC)?

Accepted Answer

To coordinate day-to-day trial activities, support subject visits, maintain regulatory documents, and ensure protocol compliance

Answer

To serve as the Principal Investigator for the trial

Answer

To independently monitor the trial on behalf of the sponsor

Answer

To conduct medical assessments and determine subject eligibility

Question 4

What must be verified during a site feasibility assessment?

Accepted Answer

Site's patient population, staff qualifications, facilities, regulatory experience, and competing studies

Answer

Only the investigator's publishing record

Answer

Whether the site has previously enrolled in any trial

Answer

Only the IRB turnaround time at that institution

Question 5

What is the purpose of a 'close-out visit' at the end of a clinical trial?

Accepted Answer

To reconcile trial supplies, ensure records are complete, archive documents, and confirm all outstanding issues are resolved

Answer

To enroll the final subject in the study

Answer

To present study results to site staff

Answer

To conduct the final data monitoring before database lock

Question 6

What is meant by 'subject recruitment and retention' strategies in clinical trial site management?

Accepted Answer

Planned approaches to identify, enroll, and keep subjects participating throughout the trial

Answer

Strategies to hire and retain site staff

Answer

Methods to retain study drug supplies at the site

Answer

Protocols for retaining regulatory documents post-trial