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

The SIV is conducted by the sponsor/CRO before enrollment to ensure site staff are trained on the protocol, CRF completion, safety reporting, and study-specific procedures.

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 delegation log records each study team member's qualifications (CV, training) and the specific tasks they are authorized to perform, signed by the PI.

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

The CRC manages the operational aspects of clinical trials including subject coordination, regulatory document maintenance, data collection, and communication with sponsor and IRB.

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

Site feasibility assesses the available patient population, investigator and staff qualifications and experience, facilities, equipment, and competing workload.

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

The close-out visit ensures all unused drug is reconciled and returned, all essential documents are archived, outstanding data queries are resolved, and the site is properly closed.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test

SOCRA CCRP Site Management