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. 2013 Jun 10;6(4):279–285. doi: 10.1111/cts.12073

Table 4.

Predictors of completion times. Table shows mean difference in calendar days related to variable. A negative value represents a reduction in the mean number of days to FE in comparison to the mean number of days for all contracts. Univariate analysis shows the duration of the process step(s) if the variant was present or absent. The Student's t‐test (p value) was used as a test for significance

Predictors of full execution times
Univariate analysis Multivariable analysis
Milestone/variable Present (days) Absent (days) p < Mean days difference p <
Final negotiation
Master agreement 34 62 < 0.0000 −33 0
Previously negotiated terms 46 57 0.034 −22 0.001
Multicenter clinical trial 54 58 0.271 6 0.389
CRO 59 53 0.865 6 0.255
Investigator initiated 70 53 0.989 15 0.088
Full execution
Master agreement 99 104 0.23 −10 0.165
Previously negotiated terms 88 106 0.009 −22 0.007
Multicenter clinical trial 103 100 0.728 8 0.401
CRO 115 99 0.992 16 0.019
Investigator initiated 107 103 0.682 9 0.437
IRB approval
Master agreement 67 64 0.684 2 0.764
Previously negotiated terms 61 66 0.237 −5 0.474
Multicenter clinical trial 67 56 0.946 11 0.154
CRO N/A N/A N/A 11 0.057
Investigator initiated 62 65 0.363 6 0.514
Contract and IRB approval
Master agreement 126 142 < 0.062 −16 0.139
Previously negotiated terms 128 140 0.137 −16 0.182
Multicenter clinical trial 135 148 0.134 0 0.995
CRO 154 131 0.986 27 0.011
Investigator initiated 169 133 0.993 36 0.033