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

What should a Clinical Research Associate (CRA) do first if they notice a discrepancy in protocol approval dates during an onsite visit?

1. Notify the investigator

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

3. Document the findings

4. Contact the sponsor directly

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

When a Clinical Research Associate (CRA) notices a discrepancy in protocol approval dates during an onsite visit, the most appropriate initial step is to confirm the dates of initial receipt of the sponsor protocol and the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) submission dates. This action is crucial for several reasons. First, confirming the actual dates helps to ensure that the CRA has the correct information before taking any further actions. It is important to establish whether the discrepancy is due to a misunderstanding, a clerical error, or a more serious compliance issue. Additionally, having accurate and verified dates allows the CRA to provide precise information to other stakeholders, such as the investigator or the study sponsor. This clear understanding is essential for the effective resolution of the discrepancy, as it will inform any necessary discussions or corrective actions. Taking this step before notifying the investigator, documenting the findings, or contacting the sponsor directly aligns with effective problem-solving practices in clinical research. The CRA’s role includes verifying data integrity and compliance, making it essential to have the correct information before proceeding with any notifications or documenting findings.