Content in this article relates to:
eCOA Solutions
NxT Platform
Swift Product
Use this guide to create a Data Change Request (DCR) for a participant when you need to request a change to submitted study data in NxT.
You start from the participant's subject details page, open Create DCR from the Queries / DCRs menu, choose the context for the request, then complete and submit the DCR form.
Summary of Process Steps
Open the participant
Select your study, press Subjects, then open the participant who needs a DCR.
Start Create DCR
On the subject details page, press Queries / DCRs and select Create DCR.
Choose DCR context
Confirm the subject and, if helpful, add visit, date, or data point details.
Complete the DCR form
Select a Reason, enter a Description, and press Submit.
Before you begin
Confirm your role includes permission to create DCRs for the participant.
Request one DCR per participant. If multiple participants need changes, repeat this process for each one.
Do not include participant-identifying information (such as name, address, or initials) in the Description field.
Write the Description in English and include enough detail for your study team to process the request—for example, form name, visit, visit date or time, current entry, and corrected entry.
If you do not see Queries / DCRs or Create DCR, contact your sponsor or CRO study management team about your permissions.
Open the participant
From Clario's Global Dashboard, open your study—for example, select it from Recently Accessed or press Select Study or Organization and choose your study from the list.
Press Subjects to open the Subjects dashboard.
Select the participant whose data you need to change.
The participant's subject details page opens. You see the participant ID, site information, and visit or data tabs such as Visits and View Data.
Start Create DCR
From the participant's subject details page:
Press Queries / DCRs.
Select Create DCR from the menu.
The Choose DCR Context window opens.
Choose DCR context
In the Choose DCR Context window:
Confirm Subject shows the correct participant ID.
Optionally, select Visit / Session, Date, and Data Point(s) to narrow the request to specific study data.
Press Submit.
The Create DCR window opens with the study, site, and subject details filled in.
Complete and submit the DCR
In the Create DCR window:
Review the guidelines at the top of the window.
Confirm Study Name, Site ID, and Subject ID are correct.
Open the Reason drop-down and select the reason that best matches your request.
In Description, explain the change you need. Include form name, visit, visit date or time, the current value, and the corrected value when applicable.
Press Submit.
Complete: NxT submits your DCR. You can monitor its status from the Queries & DCRs dashboard or by selecting View Relevant from the Queries / DCRs menu on the same participant page.
Write an effective description
Form entry correction: Form name, visit, visit date or time, incorrect response, corrected response
Visit removal: Visit name or number, date, and time of the visit to delete
Participant status: Date participation stopped and reason (for example, screen failure or early termination)
Demographics: Field to change and the correct value
Frequently Asked Questions
How do I create a DCR?
Open the participant from the Subjects dashboard, press Queries / DCRs, select Create DCR, choose the context, then complete the Reason and Description fields and press Submit.
Do I have to fill in Visit / Session, Date, or Data Point(s)?
No. Those fields are optional in Choose DCR Context. Use them when they help your study team locate the data faster.
Why don't I see Create DCR?
Your role may not include permission to create DCRs, or the option may not be available for your study configuration. Contact your sponsor or CRO study management team.
Can I create a DCR without opening a participant first?
This guide covers creating a DCR from the participant's subject details page. Some data edits in View Data also generate a DCR automatically when you sign off a change. Read the editing study data guide for that workflow.