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Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT): enrollment and data collection
| Baseline (t−1) | Randomization (t0) | 6-month follow-up (t0) | 12-month follow-up (t0) | 24-month follow-up (t0) | |
|---|---|---|---|---|---|
| Informed consent | X | ||||
| CRF from personal interviews | X | ||||
| Randomization database | X | ||||
| Registration sheets | X | X | Continuous registration | ||
| Self-assessment data | X | X | X | X | |
| Register data | X | X | X | X | |
CRF Case report form
