Table of Contents
- Title and Copyright Information
- Preface
- 1 Before you sign in
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2
Manage subjects
- Add and screen a subject
- Dispense kits after a titration error
- Enroll a subject in a rollover study
- Mark a subject as complete
- Undo or edit a subject's completion of a study
- Mark a visit that a subject misses as skipped
- Randomize a subject after Oracle Clinical One Platform didn't allow you to randomize
- Cancel a subject
- Re-sign a subject's data
- Screen fail a subject
- Undo or edit a subject's screen failure
- Start a dynamic visit for a subject
- Sign at the subject level
- Sign at the visit level
- Sign at the form level
- Unblind a subject's treatment arm (code break)
- Update a subject number
- Withdraw a subject
- Undo or edit a subject's withdrawal
- What states can a subject have?
- After undoing the event I cannot complete or withdraw a subject
- Link subjects for Electronic Health Record (EHR) data import
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3
Enter data and dispense kits
- About collecting adverse event data when integrating with Safety
- About required questions for Randomization and Trial Supply Management (RTSM) events
- Edit a safety case
- Manage safety cases
- View the details of a safety case
- About clearing or removing data
- About deleting, restoring, and viewing deleted form records
- About the Query List
- About updates to a dynamic question
- Answer a query
- Apply a data flag to a question
- Clear a visit date
- Clear form data
- Complete a randomization or dispensation visit
- Complete a dispensation visit with dose changes
- Complete an unscheduled dispensation visit
- Enter data for an adverse event
- Enter data in a form with two sections
- Enter data in a repeating form
- Link forms
- Restore deleted forms
- Update a value on a completed form
- Update the answer to a dynamic question
- Upload or delete documents from forms
- Work in the Query List
- View dispensed kit numbers and dosing instructions
- Import Electronic Health Record (EHR) data
- 4 Manage and dispense devices
- 5 Manage labs and lab forms
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6
Receive and manage an investigational product
- Confirm dispensation of kits
- Conserve and re-dispense kits
- Conserve and re-dispense kits during a titration visit
- Perform a partial dispensation
- Pause dispensation by placing a dose hold
- Register a shipment
- Dispense a replacement kit (for lost, damaged, or not dispensed kits)
- Mark a kit as missing or damaged at your site
- Mark a kit that was dispensed in error or not dispensed to the subject
- Request extra supply for a clinic day
- Check on a late shipment
- 7 Perform kit reconciliation
- 8 Run reports, generate archives, and view notifications
- 9 Perform end-of-study activities
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10
Troubleshoot
- Kits and dispensation
- Navigation
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Subjects and visits
- An error occurs when I try to randomize a subject
- A query is added on a form after I sign data
- A subject failed screening, and I need to rescreen the subject
- A submitted visit remains in the Next Visit column
- I can't click Randomize or Dispense during a visit
- I can't edit a value in a form
- I can't enroll a subject in a rollover study
- I can't sign a subject's data
- I flagged a question in error
- I need to transfer a subject
- I randomized a subject in error
- I started a randomization or dispensation visit before the visit date
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11
Frequently Asked Questions (FAQs)
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Forms FAQs
- Best practices for collecting data
- Can I enter a partial date on a form?
- How can I update an auto-locked question?
- How do I know if a repeating form is complete?
- How does a hidden and required question impact a form and visit's status?
- I cannot enter data or save the data I entered in a form
- What can I do when subject data is locked?
- Which types of questions can I flag?
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Kits and dispensation FAQs
- Can I conserve a kit and re-dispense it during any of the next visits?
- Can I dispense a subject's conserved kits to another subject?
- Can I dispense misallocated kits again?
- Can I still dispense kits if titration isn't allowed?
- How do I dispense the same device to another subject?
- Learn the details of performing a dose hold
- What do I do with kits that can't be conserved?
- What is the workflow for dispensing Unblinded Pharmacist kits?
- Available inventory statuses for kits
- Where can I view unblinding details during an open-label period?
- Why are barcodes useful in a study?
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Subjects and visits FAQs
- Can I remove a visit from a subject's schedule?
- How is the visit schedule affected when I skip a visit or update a visit start date?
- How do visits display in subject listings view, when integrations populate a future visit?
- What actions impact subjects?
- What does each icon mean for signing, verifying, or freezing data?
- What do I do when a subject has reached their dosing limit?
- What statuses can a visit have?
- What time zone is subject data in?
- When is a visit considered complete?
- How do I get training in Oracle Clinical One Platform?
- What keyboard shortcuts can I use?
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Forms FAQs
- 12 Revision history