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Table 3 Percentage of SDV done for differing classifications of data

From: Monitoring in practice – How are UK academic clinical trials monitored? A survey

 

%SDV

Total

100

60

50

30

20

15

10

5

0

All data

0

0

2

1

3

1

5

1

2

15

Consent

19

0

2

1

0

0

0

0

0

22

Eligibility criteria

13

0

2

1

0

0

1

1

1

19

Primary endpoint reports

13

0

0

1

0

0

3

1

0

18

Secondary endpoint reports

4

1

1

1

1

0

6

1

2

17

SAE: Serious adverse event reports

14

0

1

1

0

0

1

1

1

19

AE: Non-serious adverse event reports

4

0

0

1

1

0

7

1

3

17

Selected priority data

8

0

0

1

0

0

3

1

5

18

  1. Bold font shows where there appears to be a consensus, i.e. where more than two thirds of the respondents gave the same answer. Columns represent the %SDV that CTUs gave in response to the question
  2. AE adverse event, CTU clinical trial unit, SAE serious adverse event, SDV source data verification