Software for clinical data managers, from build to lock
Data managers design the forms, write the checks, chase the queries and sign off the lock. Capture gives you the tools for each step in one system, without waiting on a vendor for every change.
- Build it yourself
- Queries at entry
- Freeze and lock by field or in bulk
Free sandbox · No credit card · 21 CFR Part 11 aligned
What data managers get
- Build: AI drafts visits and forms from the protocol, and forms or lab tables from a description or file, for your review.
- Checks: range and custom-value edit checks with configurable priority raise auto-queries the moment a value breaks a rule.
- Cleaning: one query list with status, priority and age, answerable in place from the casebook and exportable to CSV.
- Lock: freeze and lock data field by field or in bulk; unfreezing or unlocking requires a reason.
- Outputs: CSV and Excel exports with a data dictionary, raw and decoded files, blank eCRF PDFs and configuration export for the next study.
Build
Specifications that become the study
In many organisations, data managers write CRF specifications and edit check specifications in documents, and someone else builds them. Every round trip adds time and room for error. In Capture, the specification and the build are the same thing: forms, fields, calculated values and edit checks are configured directly, tested in the sandbox, and approved.
Forms move from draft to approved. Approved forms are locked for live use and only approved forms appear in the casebook, so an amendment is a deliberate, recorded step. The blank eCRF PDF gives reviewers and ethics committees the full casebook to review. See the data management plan template.
Calculated fields
BMI, BSA, eGFR (CKD-EPI 2021), creatinine clearance, QTc corrections, age from date of birth and time between two date-times are available as calculated fields shown read-only during entry, which removes a common source of manual errors.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
Cleaning
One query list for everyone
Edit checks raise queries as data is entered, and monitors raise their own. Everyone works the same list, with status, priority and age visible. Queries can be answered in place from the casebook, and the whole list exports to CSV for reporting.
- Auto-queries with priority.
- Manual queries from monitors.
- Query list export.
Lock
Freeze and lock as you go
Freeze and lock cleaned data field by field or in bulk, so the final lock is a confirmation rather than a sprint. Unfreezing or unlocking requires a reason, and every change is recorded in the audit trail.
- Freeze and lock by field or in bulk.
- Reason required to unlock.
- Status overview of every subject and visit.
Build, break and clean a sample study
Set edit checks and work the query list in the free sandbox.
Day to day
Data management tasks and where they happen
| Task | In Capture |
|---|---|
| CRF design | Visual builder with AI drafting; ten question types plus table sections |
| Edit check specification | Range and custom-value rules configured per field |
| Query management | One list with status, priority and age; CSV export |
| SDV coordination | SDV set per field for monitors |
| Data review | Status overview and dashboard filters by site and country |
| Lock | Freeze and lock by field or in bulk, with reasons for unlocking |
| Exports | CSV and Excel with data dictionary, raw and decoded |
External data
Reconciliation and coding
Most studies have data that does not start in the EDC: central laboratory results, ECG readings, imaging reads and the safety database. Data managers reconcile these against the EDC at agreed intervals, checking that participants, visits and dates match and that serious adverse events agree between the clinical and safety databases.
Medical coding of adverse events, medical history and medications, usually with MedDRA and WHODrug, is another data management step to plan: who codes, when, and how coding is reviewed. Write these processes into the data management plan so they run throughout the study, not only before lock.
Getting started
Data manager evaluation checklist
Build a real form
Including calculated fields and a table section.
Write edit checks
Range and custom-value rules with priorities.
Work the query list
Raise, answer and close queries.
Freeze and lock
Try field-level and bulk operations.
Export
Check the data dictionary and decoded files.
Reuse
Export a configuration and import it into a new study.
How is external data reconciled?
At agreed intervals, by checking participants, visits, dates and SAEs against the external source.
Where does medical coding happen?
Plan it in the data management plan: who codes with MedDRA and WHODrug, when, and how it is reviewed.
Can data managers build studies without the vendor?
Yes. Forms, edit checks, calculated fields and schedules are configured in the visual builder, with AI drafting for review.
How are queries handled?
Edit checks raise auto-queries at entry, monitors raise manual queries, and everyone works one list with status, priority and age.
Can data be locked before the end of the study?
Yes. Data managers can freeze and lock data field by field or in bulk at any time.
What exports are available?
CSV and Excel exports with an automatic data dictionary, raw and decoded files, and date-range and site filters.
Can I reuse a study build?
Yes. A study configuration can be exported and imported into a new study as a starting point.
Can I try it free?
Yes, in the free sandbox with every feature.
Data management without the wait
Build, clean and lock in one system. Free sandbox.