EDC · Electronic Data Capture
Every value entered once.
Signed for good.
Design the study, release it through a tested and signed version, then enrol, capture, clean, verify, sign and lock, all on one audit trail.
The study, start to finish
Eight stages, one record.
- 01
Design
Draw the case report forms, or draft one with AI or copy it from the form library. Add the visit schedule with its windows, map forms to visits and write the cross-form rules.
- 02
Test and release
Forms, visits, mapping and rules are sealed into one version and tested in a UAT workspace. It goes Live only after three sign-offs: author, QA and approver.
- 03
Open sites
Record the ethics approval, confirm GCP training and activate the site. The investigator signs the delegation of authority for site staff.
- 04
Enrol
Consent, screening and the investigator's eligibility decision, then each participant's visit schedule is generated. Sites and participants can be imported by CSV.
- 05
Capture
Checks run on every save, each with a severity: block, warn or raise a query. The server repeats every check and recalculates every formula. It never trusts the browser.
- 06
Clean
Queries keep duties apart: whoever raises one cannot answer it, and whoever answers cannot close it. Automatic queries close themselves once the check stops firing.
- 07
Verify
A targeted source-verification plan sets what monitors check. A verification goes stale, and back to the monitor's queue, the moment its value changes.
- 08
Sign and lock
The investigator signs each record; a later change is a controlled correction that withdraws the signature. Close with a two-person database lock.
Separation of duties
The raiser cannot answer. The answerer cannot close.
| Act | Who may | Who may not |
|---|---|---|
| Enter and change data | Coordinator, Investigator | Data management, administrators |
| Raise a query | Data Manager, CRA, Medical Officer, Monitor | The site |
| Answer a query | Investigator, Coordinator | Whoever raised it |
| Close a query | Data Manager, Medical Officer, Data Coordinator | The site, and whoever answered |
| Verify against source | Clinical Research Associate | Whoever wrote the plan or entered the value |
| Sign a record | Principal Investigator | Everyone else |
Also in the EDC
The parts a study needs around the data.
Amendments
A new version is built and tested beside the Live one. Participants move to it after re-consent, where the amendment asks for it.
Safety trail
Serious events with a reporting clock, follow-ups, medical review and a reconciliation record.
Document register
Study and site documents, versioned and controlled inside the study.
Exports
Excel, CSV and CDISC ODM-XML, each with a checksum and an audit entry.
Built for open-label studies today. Randomisation, drug supply, coding and expedited safety reporting stay in the systems you already run.
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