Practice Test GeeksCCRC - Certified Clinical Research Coordinator Practice Test
← All CCRC Flashcard Decks

CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers Flashcards

6 cards from real CCRC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers flashcards as text

  1. Which document outlines the sponsor's expectations for site conduct and is the primary agreement between a sponsor and a clinical investigator?

    Answer: Clinical Trial Agreement

    The Clinical Trial Agreement (CTA) is the binding contract between the sponsor and the site that governs financial, operational, and legal obligations.

  2. When a sponsor sends a protocol amendment that changes inclusion/exclusion criteria, what must the site coordinator do FIRST?

    Answer: Submit the amendment to the IRB for approval before implementing

    Protocol amendments that affect participant safety or study conduct must receive IRB approval before implementation at the site.

  3. During a sponsor monitoring visit, the Clinical Research Associate (CRA) requests access to source documents. What is the coordinator's obligation?

    Answer: Provide access per the consent form and applicable regulations

    Source document access for monitors is typically authorized in the informed consent form and is required under GCP to verify data integrity.

  4. A sponsor issues a Safety Letter describing a new serious risk identified in another study. What is the coordinator's required action?

    Answer: Submit the safety information to the IRB promptly

    New safety information received from the sponsor must be forwarded to the IRB in a timely manner so the IRB can assess whether consent forms or protocols need updating.

  5. What is the purpose of a Corrective and Preventive Action (CAPA) plan submitted to a sponsor after a monitoring finding?

    Answer: To document and resolve protocol deviations and prevent recurrence

    A CAPA plan identifies the root cause of a finding and details specific steps to correct the problem and prevent it from happening again.

  6. An FDA investigator arrives unannounced for a study inspection. What is the first step the coordinator should take?

    Answer: Notify the principal investigator and sponsor immediately

    The site must welcome the FDA inspector and promptly notify the PI and sponsor so the appropriate personnel and documents are made available.

How this page was made: written with AI tools and published by Nathan Beja, founder of Practice Test Geeks, who is responsible for its content. Exam facts are checked against the official sources listed below. Not reviewed by a subject-matter expert. Editorial policy

Sources & references

Exam facts on this page (fees, format, dates, passing scores) are checked against these official sources; the date is our last check. Editorial policy

  1. acrpnet.org — Eligibility, fees, exam format, score release, time limit, score validity, renewal, retake fee, retake policy, test delivery · verified Nov 2026