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Table 1 Characteristics of the studies (n = 27)

From: Comparison of two data collection processes in clinical studies: electronic and paper case report forms

   pCRFs n = 16 eCRFs n = 11 All n = 27
Design Non-interventional studies 1 (6%) 4 (36.4%) 5 (18.5%)
Clinical trials 15 (94%) 7 (63.6%) 22 (81.5%)
Randomized   10 (63%) 7 (64%) 17 (63%)
Multicenter   10 (63%) 9 (82%) 19 (70%)
Geographic level International/national 7 (44%) 8 (73%) 15 (56%)
Regional 9 (56%) 3 (27%) 12 (44%)
Purpose* Diagnostic 1 (6%) 3 (27%) 4 (15%)
Observational 0 (0%) 2 (18%) 2 (7%)
Therapeutic 15 (94%) 6 (55%) 21 (78%)
Risk level α A 2 (13%) 4 (36.4%) 6 (22%)
B 4 (25%) 3 (27%) 7 (26%)
C 3 (19%) 3 (27%) 6 (22%)
D 7 (44%) 1 (9%) 8 (30%)
Clinical trial phase 1 1 (7%) 0 (0%) 1 (4%)
2 4 (27%) 1 (14%) 5 (23%)
3 7 (47%) 6 (86%) 13 (59%)
4 3 (20%) 0 (0%) 3 (14%)
Median number of patients included*   60 355 80
Q1 = 27 Q1 = 78 Q1 = 50
Q3 = 141 Q3 = 700 Q3 = 500
Median number of centers   5 10 7
Q1 = 1 Q1 = 6 Q1 = 1
Q3 = 10 Q3 = 13 Q3 = 12
Median planned duration of study (months)   24 27 25
Q1 = 16 Q1 = 18 Q1 = 16
Q3 = 40 Q3 = 36 Q3 = 36
Median planned patient follow up (days)   137 60 91
Q1 = 67 Q1 = 12 Q1 = 30
Q3 = 365 Q3 = 112 Q3 = 213
Median number of variables in CRF   1,062 396 1011
Q1 = 669 Q1 = 153 Q1 = 286
Q3 = 1,118 Q3 = 1,567 Q3 = 1,126
Median number of variables in database β   65,928 304,929 76,692
Q1 = 18,764 Q1 = 35,250 Q1 = 20,088
Q3 = 171,646 Q3 = 625,865 Q3 = 304,929
Median number of full pages in CRF*   39 17 31
Q1 = 28 Q1 = 9 Q1 = 17
Q3 = 44 Q3 = 30 Q3 = 44
  1. *Significant difference between eCRFs and pCRFs (p < 0.05).
  2. αFrom level A = minimal, e.g. trial involving only additional blood sample collection, to D = major risk, e.g. trial of innovative therapies, phase I or II trials.
  3. βNumber of variables in database = number of patients x number of variables in CRF.