The CRF path: from design to archive
This page is a map: the whole path of the electronic case report form (eCRF) in X7 Insight, step by step, with who does it, where the button is and which documentation page covers it in detail. If you are looking for “how do I export…” or “where do I get…”, start with the Where it is in the interface table.
The eCRF path
Section titled “The eCRF path”-
Design. The study builder assembles forms, fields, codelists, edit checks, skip logic and the visit schedule in a draft version — CRF builder, Edit checks, Skip logic, Schedule of activities. Lab forms and reference ranges — the Laboratory reference ranges module.
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eCRF documents. A version is used by the server to build the CRF blank (for the site), the annotated CRF (aCRF) and the specification (PDF and Excel) — all from one design, so they never diverge. For exchange with OpenClinica — export to CRF 3.x templates. See eCRF documents.
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Configuration testing. The tester sets form risk and keeps test cases for every rule with expectations from the specification, another person confirms them, and a run records the design fingerprint — the eCRF configuration testing module. Without evidence for the current design a version is approved only with a reason.
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Review, approval, publication. The version goes Draft → In review → Approved → Published; the author and the approver are different people. Then sites are activated, UAT runs and the study goes live — Publish and launch. What was deployed and how is captured by the deployment report.
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Data entry. The coordinator enrolls subjects, randomizes them (by list, if one is uploaded) and fills in forms; changing a saved value requires a reason — Enrolling subjects, Entering data, Reason for change.
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Monitoring and cleaning. The monitor verifies data against source documents (SDV is on for new forms by default) and handles queries; the data manager follows the reports — SDV, Queries, Monitoring.
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Sign, lock, export. The investigator signs, the data manager locks the database and exports the data — Signatures, Locks, Exports.
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Inspection and archive. The sponsor’s auditor is granted view-only access with no exports; copies for inspection are prepared by the data manager — Inspector access.
Where it is in the interface
Section titled “Where it is in the interface”| What you need | Where |
|---|---|
| CRF blank for the site (PDF) | Design → version document buttons (CRF blank (PDF)) |
| Annotated CRF — aCRF (PDF) | Design → version document buttons (Annotated CRF (PDF)) |
| eCRF specification (PDF) | Design → version document buttons (Specification (PDF)) |
| Specification in Excel | Design → ⋯ → Specification (Excel) |
| Design package (JSON) for transfer | Design → ⋯ → Study package (JSON) |
| Deployment report (ZIP) | Design → version document buttons (Deployment report) |
| Export to OpenClinica (.xls) | Draft builder → the “OpenClinica: import and export” panel in the inspector |
| eCRF configuration test report | Design → Version documents → eCRF configuration testing → Report |
| Lab reference ranges, Excel import and export | Study menu → Setup → Lab ranges |
| Randomization list and code-break log | Study menu → Randomization |
| Emergency code break for a subject | Subject ⋯ menu → Emergency code break… |
| Query export (Excel / PDF) | Queries → the Export XLSX / Print PDF buttons (by the current filters) |
| SDV verification report (Excel / PDF) | SDV → the Export XLSX / Print PDF buttons (honors the selected site) |
| Subject casebook (PDF) | Subject card → ⋯ menu → Subject documents |
| Subject audit trail (PDF) | Subject card → ⋯ menu → Subject documents |
| Site data copy (ZIP) | Locks → Site data copies |
| Sponsor auditor access (read-only) | Team → Add to team → the Auditor (read-only) role and a “valid to” date |
Who does what
Section titled “Who does what”Each step of the eCRF path has its own role: the study builder and the configuration tester prepare and check the forms, the coordinator enters data, the monitor runs SDV and queries, the investigator signs and performs emergency code breaks, the data manager locks the database and exports, the unblinded statistician keeps the randomization list, and the sponsor’s auditor gets view-only access. The full table of roles and their permissions is in Roles and access.