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Table 2 Comparison of mean time for accomplishing different tasks for a clinical trial startup phase before and after implementation of the intervention protocol

From: Streamlining and cycle time reduction of the startup phase of clinical trials

 

Before implementing the intervention

After implementing the intervention

P value

Percentage reduction

Mean [SD] (week)

Mean [SD] (week)

PCLM approval

1.7 [2.0]

0.7 [0.94]

0.59

60.4

IDS approval

4.2 [3.6]

1. 5 [2.7]

0.27

64.9

IRB approval

7.5 [3.1]

6.6 [5.7]

0.27

12

From confidentiality agreement to IRB approval

24.8 [8.2]

13.5 [11.6]

0.36

45.6

  1. Abbreviations: PCLM pathology and clinical laboratory medicine, IDS investigational drug service, IRB institutional review board