Regulatory teams need study data systems that support submissions, amendments, safety reporting and inspections without a scramble. Capture produces the documents you need and records the evidence regulators ask for.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
What regulatory teams need
Submissions
Ethics committees and some authorities ask to see the case report forms and participant-facing materials. Capture exports a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form, and a blank ePRO PDF showing each questionnaire as it appears on a phone, with answer options, skip logic and schedule. Because they come from the live configuration, they match what sites and participants will actually see.
For trials under the EU Clinical Trials Regulation, the application goes through CTIS; in the US, IND submissions and IRB review follow their own processes. See the IRB submission checklist and EU CTR clinical trial software.
Forms move from draft to approved, approved forms are locked for live use, and changes are recorded in the audit trail. Plan form changes alongside protocol amendments so that new versions go live only after the amendment is approved.
Blank ePRO · patient questionnaires
Evening diary
Daily 18:00 to 24:00, Visit 1 to Visit 15
2. Did you take your study medication today?
○ Yes○ NoQuestion 3 shown only if No.
Safety reporting
A serious event raises a routed safety alert straight away. Capture tracks the SAE timeline from site awareness, collects the site attestation and investigator sign-off, and records who acknowledged the alert. Safety listings and E2B export support reporting to safety databases and authorities.
SAE timeline
SAE reported
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
AE sign-off (PI / Sub-I)
Awaiting signature
Build a sample study in the free sandbox and export it.
Tasks
| Task | Supporting record |
|---|---|
| Ethics and authority submissions | Blank eCRF and blank ePRO PDFs |
| Protocol amendments | Draft and approved form versions; audit trail of changes |
| Expedited safety reporting | SAE timeline from awareness, sign-off, E2B export |
| Registry and results reporting | Exports with data dictionary for analysis |
| Inspections | Audit trail, signatures and access records by participant and date |
| Country requirements | Hosting region, encryption and data separation answers |
Inspections
Inspectors ask practical questions: show me who entered this value, when it was changed and why; show me the signed consent for this participant; show me who had access to the unblinded data. The faster those questions are answered, the smoother the inspection. A field-level audit trail with readable descriptions, filters by participant and date, and exports on demand make the difference.
Prepare by running a retrieval drill before the inspection: pick participants at random and pull their consent, eligibility, key efficacy data and safety data with the audit trail. See the FDA inspection checklist.
Transparency
Most trials must be registered in a public registry before enrolment, and many must post summary results within set timelines, for example on ClinicalTrials.gov for applicable US trials and through CTIS for trials under the EU regulation. Medical journals also require registration before publication.
Results reporting draws on the same data as the clinical study report: participant flow, baseline characteristics, outcome measures and adverse events. Clean exports with a data dictionary make those tables faster to produce. Plan who owns registration and results reporting from the start of the study.
Evaluation
Check it matches the live forms.
Draft, approve and lock a form change.
Report a test SAE and follow the timeline.
Listings and E2B export.
Pull one participant's records with audit trail.
Region, encryption and access for each country.
Most must be registered in a public registry before enrolment, and many must post summary results.
Yes. Exports with a data dictionary support participant flow, baseline and outcome tables.
Yes. The blank eCRF PDF includes a cover page, form index, visit-by-form matrix and every approved form.
Forms move from draft to approved, approved forms are locked for live use, and changes are recorded in the audit trail.
Yes. SAE timelines are tracked from site awareness with investigator sign-off, and safety listings and E2B export are available.
In the EU (Frankfurt) or the US (N. Virginia), chosen at study setup.
Yes. The audit trail can be filtered by participant and date and exported, along with signed consent PDFs.
Yes, in the free sandbox with every feature.
Keep exploring
Blank eCRFs, controlled amendments and safety exports. Free sandbox.