An eCRF is the questionnaire filled in by the clinical team to document a subject's clinical data, visit by visit. It replaces the paper Case Report Form. This article covers the vocabulary and what each study status allows, so the rest of the guides make sense.
Definitions
eCRF (Electronic Case Report Form): a digital questionnaire completed on site or remotely, on a tablet or a computer, by clinical staff or investigators. Unlike an ePRO, which the subject answers themselves, an eCRF is filled in by the clinical team.
eCRF form: the questionnaire you design in the eCRF Builder. A study contains one eCRF form.
eCRF record: one subject's eCRF, listed in the Inclusions list.
eCRF Builder: where you design the structure, the sections and the questions. It is open only when the study is Draft or Suspended.
Inclusions list: every subject's eCRF in the study, and the place you open a subject's forms from.
Monitoring: the review tools built on eCRF data, covering queries, data review, SDV and missing data. See Data monitoring.
How the structure translates
In Datacapt | In your study | What it holds |
Section | A visit | The forms to complete at that visit |
Sub-section | A form | The questions of that form |
Question | A data point | The value the site records |
The platform says section and sub-section everywhere, because the same builder serves eCRF, ePRO, eConsent and recruitment surveys. In a clinical study, read them as visits and forms. The eCRF itself uses the second vocabulary: the buttons at the bottom of a form say Previous form and Next form, and they move you between sub-sections.
What the study status changes
The study status decides whether you can edit the eCRF at all, and whether the data you collect is test data or real. It governs the prerequisite of almost every other eCRF guide.
Status | What you can do |
Draft | Build the eCRF, add test subjects, and test everything. Test data can be collected, signed and excluded. |
Live | Add real subjects and collect real data. The eCRF Builder is closed. |
Suspended | The eCRF Builder reopens and data collection is locked. This is how you change an eCRF mid-study, then return to Live. |
Ended | The database is locked in one click. eCRF, ePRO and eConsent data and queries all become read-only. You can move back to Live, but you must give a reason, which is recorded in the audit trail. |
Archived | The study appears only when Archived is checked in the study list filter. |
⚠️ Warning: moving from Draft to Live deletes every test subject and all their data, so that real data is never mixed with test data. Be sure the eCRF is validated before you confirm the change.
Frequently asked questions
Can a study contain more than one eCRF form?
Can a study contain more than one eCRF form?
No. One clinical EDC study contains one eCRF form. Use sections and sub-sections inside it to organize visits and forms.
How do I change the eCRF once the study is Live?
How do I change the eCRF once the study is Live?
Set the study status to Suspended. The Builder reopens and data collection is locked while you work. Set the study back to Live once your changes are implemented.
What happens to my test subjects when the study goes Live?
What happens to my test subjects when the study goes Live?
They are deleted, along with any data recorded against them. Only add test subjects while the study is in Draft.
Can I reopen a study after ending it?
Can I reopen a study after ending it?
Yes. A study in Ended status can be moved back to Live. You must give a reason, and it is recorded in the audit trail.