Fig. 3.

Simulation results for Sites A to F under the conditions listed in Table 3. X = number of subjects, Y = work hours, solid line: eSource DDC, broken line: traditional method. Thresholds: The minimum number of subjects for which the overall hours with eSource DDC are less than those for a clinical trial conducted using the traditional. Table 3 shows the distribution of the eCRF fields as defined in the SDIL. The number of fields included in the form defined as DDC in SIDL was used as the condition for this simulation as the number of DDC fields