Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

The correct answer highlights the importance of regulatory compliance and ethical oversight in clinical research operations. Before releasing non-refundable start-up fees, some sponsors require the completion of all regulatory documents and the receipt of Institutional Review Board (IRB) approval to ensure that the study meets all legal and ethical standards. This step is crucial as it demonstrates that the research protocol has undergone necessary scrutiny to protect participants' rights and welfare, thus providing a layer of assurance to the sponsors regarding the study's integrity.

Other options, while relevant to various stages of study initiation, do not have the legal and ethical implications that come with regulatory document completion and IRB review. For instance, finalizing the budget is essential for financial planning, and completing subject assessments or first subject enrollment indicates progress in the study but does not necessarily assure compliance with ethical standards. Therefore, the requirement for regulatory documents and IRB approval reflects the sponsors' prioritization of responsible clinical research practices.