Analysis of managing fee for investigational products

The managing fee for investigational products in the 13 trials which were completed in our hospital during the 2003 fiscal year was analyzed based on the actual performance as well as the result calculated on the point table. Furthermore, the method to calculate the managing fee and the actual amount of the fee in the 24 trials on-going in the Institution November 2003 were surveyed. Our results indicate that 4 elements are necessary, 6 elements are unnecessary, and 6 elements should be reconsidered as to their weight and point for judging among the 16 elements in the point table. We also found that production and maintenance of documents specified by GCP and SOP for investigational product management, management of empty bottles, and careful consideration to the investigational product management form for each subject should be added as new elements. Most institutions calculate the managing fee for investigational products based on the investigational fee of clinical research. The current system for the managing fee of investigational products in the national hospitals is not very expensive compared with other institutions.