Financial management of large, multi-center trials in a challenging funding milieu

Table 2 Fundamental scheme of the hybrid financial management model utilized by D2d for a typical site that projected to enroll (i.e., randomize) 125 participants

	Year 1	Year 2	Year 3	Year 4	Year 5	Total
Personnel (effort and fringe benefits)	178,135	183,100	183,100	137,171	137,171
Non-personnel	44,534	65,586	60,208	22,043	12,297
Total proposed budget	222,669	248,686	243,308	159,214	149,468	1,023,345
Core
Proposed Core^a	89,068	91,550	91,550	68,586	68,586	409,339
Actual Core^b	89,068	99,474	99,474	99,474	21,848	409,339
Performance-Based Payments
PBP amount per enrolled participant: 4912						614,007

Amounts shown in US$; numbers include directs and 53% indirect rate. The scheme is flexible both from year to year and from site to site, while maintaining consistency
^aProposed Core was defined at the start of the study as 50% of annual personnel costs
^bActual Core varied from year to year (see text) while the total amount over 5 years did not exceed the total proposed Core (i.e., US$409,339)

ISSN: 1745-6215