What is X7 Insight EDC

X7 Insight EDC 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 participant data, monitors verify it against source documents, investigators sign, and data managers lock the database and export data into regulatory formats. Every change is written to an immutable audit trail — you can always answer the question “who, when, and why.”

Who this documentation is for

This guide is written for clinical staff, not programmers. No technical knowledge is required. It will be useful if your role is one of these:

Who	What they do in X7 Insight
Coordinator (CRC)	enrolls participants, enters visit data, responds to queries
Monitor (CRA)	verifies data against source (SDV), opens and closes queries
Investigator (PI)	signs data with an electronic signature
Data Manager (DM)	runs data cleaning, locks the database, launches exports
Medical Monitor	performs the medical review of safety data
Study Builder	assembles the study design: forms, code lists, rules
Administrator	manages access, roles, and tenant modules
Inspector / auditor	views data and the audit trail in read-only mode

A role is not a job title

In X7 Insight, roles are configurable sets of permissions, not hard-coded “job titles.” Exactly what you can access depends on the permissions granted to you in a specific study or site. Learn more in Roles and access.

How the data journey is structured

Work in a study moves from left to right — from a clean design to a locked, signed, and exported database:

1. Designpublished
2. Capturedata entered
3. Cleaningsigned & locked
4. Closeout

The study journey: from a clean design to a signed and exported database.

What happens in each phase:

1. Design. The Study Builder assembles electronic forms (CRFs), code lists, validation rules (edit checks), and the visit schedule (SoA). The design goes through review and approval, then is published. A published version is immutable — this is the foundation of reproducibility. See Study design.
2. Capture. The coordinator enrolls a participant, opens a visit and a form, and enters values. Editing an already-saved value requires stating a Reason for Change (RfC). See Data entry.
3. Cleaning. Queries are opened and resolved, the monitor performs source data verification (SDV), the medical monitor performs the medical review, and the coder codes terms. See Monitoring and cleaning.
4. Closeout. The investigator signs the data, the data manager locks the database (soft → hard lock) and exports a snapshot into regulatory formats. When the protocol is amended, subjects migrate to the new design version. See Signatures, locks, export.

Note

Data is never silently deleted. A “not done” flag, a consent withdrawal, an erroneous entry — all of it remains in the value’s history and in the audit trail. Only availability and status change, not the fact that a record once existed.

Three principles you will feel right away

• “Where am I / what’s next / what can I do.” Every screen answers three questions: breadcrumbs show where you are; status badges and hints show what to do next; the action panel shows what you are allowed to do.
• Permission = visibility. You see only the buttons and sections you have the right to. If an action is not on the screen, it means it is not available to you in this context.
• Statuses are independent. A single record has several status “axes” at once: data entry, SDV, queries, signature, lock, medical review. They do not merge into one “overall status” — each is shown as a separate badge.

Brief glossary

The full glossary is in the reference section. The essentials to start with:

Term	What it is
Study	an entire clinical trial
Site	a research site (clinic) within a study
Subject	a study participant
Visit	a schedule point (StudyEventInstance) that forms are attached to
CRF / form	an electronic form for entering visit data
Casebook	a “visits × forms” matrix for a single subject
Query	a question about the data: a discrepancy, clarification, or remark
SDV	Source Data Verification — reconciling data against source documents
RfC	Reason for Change — a mandatory reason when editing a saved value
Signature	an electronic signature (21 CFR Part 11) over a snapshot of data
Lock	locking data against changes (soft and hard)
Scope	the reach of a permission: study → site → subject → form
Audit trail	an immutable log of all changes with a cryptographic chain
Module	a pluggable capability on top of the core (coding, export, RTSM, etc.)

Signing inEmail and password, the second factor (TOTP), invitations, and SSO.

How the interface worksAreas, breadcrumbs, language, theme, permission-gated UI.

Your task queueA cross-cutting list of work: queries, signatures, SDV.

Roles and accessWho can do what and where your access comes from.