Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

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What items typically require an invoice and are not included in the per subject payment?

Non-procedural fees

In the context of clinical trials and site payments, non-procedural fees typically refer to specifics that are billed separately and are not factored into the per subject payment model. This can include a variety of costs that are essential for conducting clinical research but do not directly involve conducting procedures on subjects. These fees often encompass administrative costs, training, and other essential services needed to support the clinical study without being tied to the actions performed on each participant.

Such items require an invoice because they are billed based on actual incurred expenses rather than being calculated as a function of the number of subjects enrolled or treated. This distinction helps establish a clear accounting of costs incurred during the trial, ensuring transparency.

In contrast, the other items mentioned, such as regulatory document fees, site initiation fees, and administrative costs for personnel, often have varying implications based on the trial's structure and are frequently included in the overall budgeting or per subject payment discussions. Thus, it is essential to identify non-procedural fees as distinct items that necessitate invoicing independently from the routine per subject payments made for participant-related activities.

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Regulatory document fees

Site initiation fees

Admin costs for personnel

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