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- Screening is used to determine if a subject meets the criteria to be included in the study
- There can be multiple screening encounters
- Screening encounters can also be used for visits that occur before Baseline/Time 0 but do not affect screening status
- The encounter that is set for Baseline determines the projected date of the follow-up encounters
- Baseline would be set for the visit that starts the timeline and prior visits would be set up as screening visits
- All screening encounters must occur before Baseline/Time 0
- Subjects who have not passed screening (they are still in-process or failed screening) cannot move to their Baseline or Follow-up encounters
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Subject Login
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- Used to allow subjects to log in and enter data
- Subjects are set up with their own username and password from the Subject Overview page (by users with a Subject Administration role)
- Subjects will only see the forms that are selected
- See the Subject Data Entry page for more details
Versioning
Electronic Signatures
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