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Table 4 Comparison of actual versus simulated system performance measures. Simulated data was produced by 38 replications of the simulation model

From: Activating clinical trials: a process improvement approach

Sub-process

Average duration in calendar days

Actual

Simulated (95 % CI)

Initial Preparation

11.0a

10.9 (0.1)

Contract Negotiation

54.9

51.6 (4.5)

Budget Negotiation

46.3

45.3 (3.9)

PI Approval

4.8

4.6 (0.2)

DSR Approval

2.5

2.4 (0.1)

Sponsor Approval

5.5

5.2 (0.4)

Entire Process

76.6

82.0 (3.5)

Trials arriving/leaving

Average number per year

Actual

Simulated (95 % CI)

Number in

147.0

143.7 (4.3)

Number out

78.0

74.5 (3.2)

Still in process

52.0

78.6 (5.1)

  1. CI confidence interval, DSR USF’s Division of Sponsored Research, PI principal investigator
  2. aEstimated by OCR senior personnel