Documentation
X7 Insight EDC
Electronic data capture for clinical trials — from protocol design to a signed, reproducible export.
- Designed for GxP requirements
- Immutable audit trail
- Electronic signatures and locks
What is X7 Insight EDC
Section titled “What is X7 Insight EDC”X7 Insight is an electronic data capture (EDC) platform for clinical trials. In it, the study team designs electronic forms (CRFs) and the visit schedule, coordinators enter patient data, monitors verify it against source documents, investigators sign, and data managers lock the database and produce a reproducible export with checksums. Every change is recorded in an immutable audit trail.
This documentation is for clinical staff: coordinators (CRCs), monitors (CRAs), data managers, investigators (PIs), medical monitors, coders, and administrators. No technical knowledge is required.
Signing in, how the interface is laid out, your task queue.
Roles & accessWho can do what, assigning roles, separation of duties.
Study designCreating a study, the visual CRF Builder, checklists, go-live.
Data entryEnrolling subjects, the casebook, entering and editing values.
Monitoring & cleaningQueries, source data verification, medical review.
Signatures, locks, exportElectronic signatures, database lock, exports, amendments.
ModulesDomain features are modules on top of the core — with no core changes.
Compliance & auditAudit trail, electronic signatures, blinding and privacy.
ReferenceGlossary, status lifecycles, permission catalog.
How work in a study is organized
Section titled “How work in a study is organized”The typical data journey in X7 Insight, left to right. Each phase carries the colour of its matching status axis in the platform itself.
Design
The Study Builder assembles forms, code lists, edit checks, and the visit schedule; the design goes through review and is published.
Collection
A coordinator enrolls a subject, opens a visit and a form, and enters data; edits to already-saved values require a stated reason.
Cleaning
Queries are opened and resolved; a monitor verifies data against source (SDV); a medical monitor performs a review; a coder codes terms.
Close-out
An investigator signs, a data manager locks the database and exports the data; when the protocol is amended, subjects migrate to a new design version.