Running Your Study on Qualtrics? Here Is the Compliance Gap
Qualtrics is a widely used enterprise survey and experience-management platform, and many academic and small research teams reach for it because their institution already has a license. It was built for market research and experience surveys, not for regulated clinical trial data. Capture.Study is a purpose-built EDC with a clinical-grade audit trail, e-signature workflow and edit checks included from day one.
Who This Comparison Is For
This page is not "Qualtrics vs Capture" in the usual sense; Qualtrics was not built to be a clinical EDC. It is useful if:
You're collecting trial data in Qualtrics because your institution already has a license
- Fine for a simple internal opinion survey with no participant PII
- A regulated or sponsor-facing study needs more than that
You just need a quick internal survey, not a regulated study
- If there is no IRB, no sponsor, and no participant PII involved, Qualtrics may still be the right tool
- This page is for the moment that stops being true
Quick Comparison Table
| Feature | Capture.Study | Qualtrics |
|---|---|---|
| Purpose-built for regulated clinical trial data | General-purpose survey and experience-management platform | |
| Field-level audit trail (who, when, old value, new value, reason) | Standard survey response logging, not a clinical-grade audit trail | |
| Investigator e-signature with countersignature | Not a clinical e-signature workflow | |
| Edit checks that auto-raise a query | No clinical query management workflow | |
| Role-based access with participant PII segregation | General survey access controls, not clinical role separation | |
| AI drafts CRFs from a protocol or description | Not applicable; general-purpose survey builder | |
| 21 CFR Part 11-aligned controls | Not positioned around Part 11 for clinical trials, per their own site | |
| Free sandbox to test with sample data | Requires an existing license, typically institutional |
We built this table from Qualtrics' own general product positioning as a survey and experience-management (XM) platform. If anything here is out of date, let us know.
Why Teams Start on Qualtrics
Most academic and small research teams do not choose Qualtrics for its clinical fit; they choose it because their university or organization already has a license and the survey builder is familiar. That works well for a quick internal survey. It stops working the moment a study needs an audit trail a monitor will accept, an e-signature workflow, or edit checks that catch a bad value automatically.
Scope
Qualtrics is a horizontal survey and experience-management (XM) platform used across market research, employee experience and customer experience, per its own general product positioning. The clinical data capture controls a regulated trial needs, a field-level audit trail, an e-signature workflow, and edit checks that raise a query automatically, are not part of what a general survey tool is built to do. Capture.Study is purpose-built for exactly that.
Compliance
Qualtrics carries broad enterprise security certifications for general survey and experience data, but nothing on its public site positions it specifically as a 21 CFR Part 11 clinical EDC. Capture.Study provides 21 CFR Part 11-aligned controls today: a field-level audit trail that cannot be edited from the app, OTP-verified electronic signatures with countersignature, and role-based access, with documentation to support your own validation on Enterprise plans.
Pricing
Qualtrics is typically already covered by an institutional license, so it can feel free to the individual researcher, but that licensing isn't built around per-study clinical trial pricing or clinical-grade controls. Capture.Study includes a free sandbox to build and test a full study, with paid plans that scale by study size once you go live.
When Qualtrics Is Still Fine
A quick internal survey with no participant PII
If there is no IRB, no sponsor, and no participant PII involved, and you are not planning to submit the results anywhere regulated, Qualtrics can be the simpler tool.
A non-regulated, market-research-style questionnaire
General opinion or experience surveys outside a clinical protocol are exactly what Qualtrics was designed for.
When Capture.Study Is the Better Choice
Your study will go in front of an IRB, a sponsor, or a regulatory submission
Any of these means you need an audit trail and e-signatures a monitor will actually accept.
You need edit checks and auto-queries, not manual review
Configurable rules raise a query automatically when a value breaks a check, instead of a manual pass through responses.
You want to migrate an existing survey into a compliant CRF
Rebuild your existing Qualtrics questions as a CRF or ePRO form, or let the AI draft a first pass from a description.
Frequently Asked Questions
Is Qualtrics 21 CFR Part 11 compliant?
Qualtrics is a general-purpose survey and experience-management platform. Nothing in its own public positioning claims Part 11 compliance for clinical trials, so most regulated studies need a purpose-built EDC alongside or instead of it.
Can we migrate an existing Qualtrics survey into Capture.Study?
Yes. You can rebuild an existing survey as a CRF or ePRO form, or upload a description or file and let the AI draft a starting point for your team to review.
Is Capture.Study free to test?
Yes. The free sandbox includes every feature with sample data, no credit card and no time limit.
Is Capture.Study 21 CFR Part 11-aligned?
Yes. Capture.Study provides a field-level audit trail, OTP-verified electronic signatures with countersignature, and role-based access control, with documentation to support sponsor validation on Enterprise plans.
Move Your Study Off a Survey Tool
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