Smart Data Quality (SDQ)
Integrated Data Review Assist (IDRA)

Integrated Data Review Assist brings data-review-plan creation, collaborative review, and compliance tracking together — with check recommendations by therapeutic area and metadata.

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Smart Data Quality (SDQ) Integrated Data Review Assist (IDRA)

One platform for the data review plan

Integrated Data Review Assist (IDRA) helps study teams create, review, and track the data review plan efficiently, improving compliance with GCP and other regulations. It replaces disconnected plan documents and spreadsheets with a single platform used by every stakeholder.

IDRA recommends checks based on therapeutic area and metadata, supports collaborative review with modern UI components, and logs every change to the audit trail for full traceability.

Why teams choose IDRA

One platform

Create, review, and track the data review plan
Check recommendations by therapeutic area and metadata, with a full audit trail

One platform

Create, review, and track the data review plan

Check recommendations by therapeutic area and metadata, with a full audit trail

How IDRA works

IDRA follows a three-stage lifecycle: Draft, In-Review, and Reviewed.

Create

The owner builds an IDRA for a study using recommendations from the library and similar studies, inherits checks from other studies, or adds and imports custom checks.

Review

Assigned reviewers add plan- and check-level comments and request modifications; once all reviewers mark the plan reviewed, the owner closes open comments and moves it to Reviewed.

Track and report

Run compliance and execution reports and download the IDRA in CSV and PDF, with full version history including all previous report versions.

Metadata changes, handled. When study metadata changes, IDRA summarizes and flags the impacted checks and highlights updated values, so review stays accurate without starting over.

Create

The owner builds an IDRA for a study using recommendations from the library and similar studies, inherits checks from other studies, or adds and imports custom checks.

Review

Assigned reviewers add plan- and check-level comments and request modifications; once all reviewers mark the plan reviewed, the owner closes open comments and moves it to Reviewed.

Track and Report

Run compliance and execution reports and download the IDRA in CSV and PDF, with full version history.

Metadata changes, handled.

When study metadata changes, IDRA summarizes and flags the impacted checks and highlights updated values, so review stays accurate without starting over.

Features

Four tabs per IDRA

Overview, Checks, History, and Comments.

IDRA Library

Import an existing library via CSV and edit, activate, or inactivate checks individually or in bulk.

Metadata change handling

Automatic detection of impacted checks with quick filters for impacted and updated items.

Version history and downloads

Track every version and download in CSV and PDF.

Compliance and audit reports

A compliance report of data-review activity versus the expected review frequency, detailed metrics per IDRA check by review method, and a granular per-query audit trail with time-to-review metrics — downloadable in CSV and PDF.