CATO Associate Site Initiation & Management Flashcards

Which form must a US-based investigator complete and sign to participate in an FDA-regulated clinical investigation of an investigational drug?

Answer: FDA Form 1572 (Statement of Investigator)

FDA Form 1572 is the Statement of Investigator that US investigators must sign to participate in FDA-regulated IND studies.

During site management, what is the recommended frequency for a high-enrolling site in a Phase III trial?

Answer: More frequent monitoring visits (e.g., monthly) based on risk

Risk-based monitoring principles call for more frequent visits at high-enrolling sites to ensure data quality and subject safety.

What action should a site take when it receives a protocol amendment from the sponsor?

Answer: Submit the amendment to the IRB/IEC for review and approval before implementing applicable changes

Protocol amendments must be submitted to and approved by the IRB/IEC before implementation, except for changes needed to eliminate immediate hazards.

Which of the following best describes a 'site activation' milestone in clinical trial management?

Answer: When all regulatory approvals and contractual agreements are in place and the site is authorized to enroll

Site activation occurs when all necessary approvals, agreements, and training are complete, allowing the site to enroll subjects.

What is a 'communication log' maintained for in site management?

Answer: Documenting all significant communications between the site and sponsor/CRO

A communication log records all important exchanges between the site and sponsor/CRO to ensure accountability and an audit trail.

If a site's principal investigator leaves mid-study, what is the required first step?

Answer: Notify the sponsor and IRB and identify a qualified replacement PI

When a PI leaves during a study, the sponsor and IRB must be promptly notified and a qualified replacement PI must be identified to maintain continuity.