Guidelines for preparation budget and expenditure categories of Clinical Trial Research funded by external research funding organization, Mahidol University

Abstract

          Mahidol University conducts research studies that some studies received budget from external source of fund such as clinical trial research. Sponsor and Mahidol University/Faculties/Institutes/the Principal Investigators need to consider carefully the clinical study described in agreement and budget study. Clinical trials studies are medicine research studies, consist of multi-process steps and usually found hidden cost. Therefore, calculation costs of clinical trials shall carefully and cover all related costs. The categories costs are defined the direct costs, the fix costs and the other costs. Payment process, the Sponsor shall transfer budget to Mahidol University’s bank account, and afterwards, the financial division of Mahidol University shall transfer the budget to each of the clinical trial research as the amount of project milestone payment, subject to the transparency rules as prescribed by the university and the faculties. The expenditure categories of milestone payment shall be conducted in accordance with Mahidol University Regulation as follows: personnel cost, implementation cost, capital cost and overheads. The author is responsible for clinical trial management including financial process found that the proposed clinical trial budgets weren’t covered all costs and found some mistake of costs classification according regulation rule.

          The aim of this article is to provide guideline preparation clinical trial research budget and classified costs as following Mahidol University rules.