Viewing a non-current step — banner is informational only.
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Step
Screening Visit
Initial assessment — informed consent, eligibility review, baseline labs ordered. Until this visit completes, the participant is enrolled but not yet randomized.
Open Items
No open items.
ePRO since last visit
No ePRO entries yet — participant onboarding in progress.
Forms for this visit
Informed Consent · e-signature required
Not started
Eligibility Review
Not started
Demographics
Not started
Lab Results
No external labs attached to this visit.
Investigator Signature
Not ready for signature
Complete all required forms before routing this visit to PI sign-off.
S. Rivera — created participant record
Screening Visit opened — Informed Consent is the first form
S. Rivera — opened participant view
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Step
Visit 2 — Week 4
Week-4 follow-up. Standard panel + symptom diary; phlebotomy if indicated by the eDOA. PI sign-off required after all forms are captured and queries cleared.
Open Items
Query
Sponsor query on Visit 1 — Vital Signs · Heart rate: recorded value 42 bpm appears low; please confirm or correct.
As a Monitor, you can resolve only your own queries. The clinician resolves coordinator-targeted queries.
ePRO since last visit
3
3 ePRO responses since Visit 1 (Apr 28)
Affirmation form (“I reviewed this participant's ePRO data”) is Slice 2+.
Forms for this visit
Vital Signs · captured May 21 by S. Rivera
Complete
Symptom Diary · 2 of 8 fields complete
In progress
Adverse Events
Not started
Lab Results
Investigator Signature
Not ready — visit in progress
Complete the remaining forms and resolve open queries to enable PI sign-off.
D. Lin (CRA) — raised query on Visit 1 Vital Signs · Heart rate
External lab attached — Quest Diagnostics CBC
S. Rivera — completed Vital Signs
S. Rivera — started Symptom Diary
Visit 2 advanced — Vital Signs complete, Symptom Diary opened
S. Rivera — opened participant view
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Step
Visit 2 — Week 4
All required forms captured, queries cleared, labs attached. Awaiting investigator e-signature to close the visit.
Open Items
No open items.
ePRO since last visit
5
5 ePRO responses since Visit 1 (Apr 28)
Forms for this visit
Vital Signs · captured May 21
Complete
Symptom Diary · captured May 22
Complete
Adverse Events · captured May 23 (no events)
Complete
Lab Results
Investigator Signature
Ready for PI signature
All required forms captured, queries cleared. Routing notifies Dr. Patel (PI) and creates a Part 11 e-signature request.
S. Rivera — completed Symptom Diary
S. Rivera — resolved query on V1 Vital Signs
S. Rivera — completed Adverse Events (no events)
Visit 2 advanced — all forms complete, awaiting PI signature
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Step
Visit 3 — Week 8
Soft-window visit — data is still collectable. Collecting now records a protocol deviation with a structured reason; collecting later widens the deviation severity for the protocol record.
Open Items
No open items.
ePRO since last visit
No ePRO entries since Visit 2.
Forms for this visit
Vital Signs
Not started
Symptom Diary
Not started
Adverse Events
Not started
Lab Results
No external labs attached to this visit.
Investigator Signature
Not ready — visit incomplete
Capture the remaining forms (recording the deviation reason on collection) before routing to PI.
Window opened — Visit 3
Window closed — soft-window, collection still permitted
System flagged visit Overdue
S. Rivera — opened participant view
Viewing Visit 3 — Week 8 (Past · Data outstanding) — banner is informational only.
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Step (selected)
Visit 3 — Week 8
This visit's window closed but the protocol's window policy is soft — its forms are still collectable. Each form started here will capture a structured deviation reason on confirm; the deviation is recorded, the exclusion judgment happens elsewhere.
Open Items
No open items.
ePRO since last visit
No ePRO entries within this visit's window (Apr 20 – Apr 27).
Forms for this visit
Vital Signs
Not started
Symptom Diary
Not started
Adverse Events
Not started
Lab Results
No external labs attached to this visit.
Investigator Signature
Not ready — visit incomplete
Out-of-window collection still requires PI sign-off once all forms (and a recorded deviation reason) are captured.
Hard window closed — Visit 2; system flagged Missed
S. Rivera — recorded deviation reason for Visit 2 (Missed): participant illness
Soft window closed — Visit 3; collection still permitted
System flagged Visit 3 Data outstanding
Window opened — Visit 4
S. Rivera — opened participant view