Vital Signs
Height is recorded in cm. The following conversion factor must be used : inches x 2.54 = height in cm. Height is recorded to the nearest 1/2 cm.
float
Weight is recorded in kg - see conversion table for lbs to kg. Weight is recorded to the nearest 1/10 kg.
float
Heart rate
integer
Blood Pressure Systolic
integer
Diastolic blood pressure
integer
Baseline Adverse Events
If 'Yes', please record on the Current Medical Conditions or Adverse Events panel as appropriate. NOTE: At the Baseline Visit, only serious adverse events related to study procedures must be recorded on the Adverse Events panel. All other adverse events at the Baseline visit should be recorded on the Current Medical Conditions panel.
boolean
Concomitant Medication Prompt
If 'Yes', please record on the Prior and Concomitant Medications panel. Saving this panel after selecting 'Yes' will take you to the Prior and Concomitant Medications panel located in the Additional Forms section of the eCRF.
boolean
Urine dipstick pregnancy test
Repeat 12-lead electrocardiogram prompt
Repeat Laboratory tests
Baseline Inclusion Criteria
If 'No', check all all boxes corresponding to violations of any of the Baseline Visit inclusion criteria.
boolean
HAM-D score
boolean
CGI Severity of Illness score
boolean
Exclusion Criteria
If 'Yes', check all boxes corresponding to the Baseline Visit exclusion criteria that disqualified the subject from entry
boolean
HAM-D total delta
boolean
Note: Subjects should not be withdrawn from their current treatment regimen for the primary purpose of enrolling into this study
boolean
systolic blood pressure | diastolic blood pressure
boolean
Subject continuation prompt
----> If 'No', please complete the Study Conclusion panel and any outstanding data. ----> If 'Yes', please: - Randomise the subject into the study via the IVR system. - Dispense allocated study medication packs to the subject. - Complete the Randomisation Number panel. - Schedule Visit 3 for 7 days (+/- 3 days) time.
boolean
randomisation number
integer
Comments
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