Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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What should a CRA do first if they notice discrepancies in dates on an IRB approval letter and protocol cover page?

  1. Notify the investigator immediately

  2. Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates

  3. Request a new IRB approval letter

  4. Document the discrepancy in the monitoring report

The correct answer is: Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates

The first course of action for a Clinical Research Associate (CRA) upon noticing discrepancies in dates on an Institutional Review Board (IRB) approval letter and the protocol cover page is to confirm the dates of the initial receipt of the sponsor protocol and the IRB submission dates. This step is crucial as it establishes an accurate timeline that can help clarify the source of the discrepancy. Confirming these dates allows the CRA to gather the necessary information to understand the context surrounding the discrepancies. Having accurate dates is essential for compliance with regulatory requirements and ensuring that the study meets all ethical and procedural standards mandated by the IRB. If the CRA were to proceed to notify the investigator, request a new letter, or document the discrepancy without first verifying the details, it could lead to miscommunications or misinterpretations of the situation. By obtaining the correct dates, the CRA is better positioned to make informed decisions about the next steps and effectively address the issue with the investigator or IRB if needed.

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