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Example: Data Collection Forms Schedule
Time | -10d | Day 0 | Day 7 | Day 14 | Day 28 | Month 6 | Month 12Month 3 | Month 6 | Protocol Deviation | Adverse Event |
|---|---|---|---|---|---|---|---|---|---|---|
Windows | ±10d±10dys |
| ±1d±1day | ±2d±2wks±2d | ±1mth | ±14d | ±14dN/A | N/A | ||
Visit | Screening | Base-line | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5*Protocol Deviation | *AE | ||
Visit Overview | X | X | X | X | XX |
| X | |||
Study Eligibility | X |
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| |||
Physical Exam | X | X | X | X | XX |
| X | |||
Demographic Data | X |
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Complete Blood Count (CBC) | X |
| X | X | XX |
| X | |||
Electrocardiogram (ECG) | X | X |
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| X |
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| |||
Pregnancy Test | X | X |
|
| XX |
| X | |||
Tuberculosis Test | X |
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Vital Signs | X | X | X | X | X | X | X | |||
Adverse Event (AE) form | O O |
| O O |
| O O |
| OX | |||
Protocol Deviation | O O |
| O O |
| O O | X | O |
X = forms required to be filled out for visit
O = forms available *Event created and forms completed as needed