iReview in Clinical Data Management

JReview® is the web-enabled version of Integrated Review™ (iReview). It allows users to view, create, print, and interact with their Integrated Review™ objects locally on an Intranet or securely over the Internet. JReview® can be run in two different modes of operation (authoring and non-authoring) in addition to two modes of communication (clear-text and SSL).

iReview Common Development Practice:

• iReview allows you to saved the library of objects to be deployed at “Global” level in the production environment.
• Create separate categories (folders for DEV/QC/UAT) before approval (deployment into production)
  – “Development”
  – “QC”
• Create study specific folders under those categories (e.g. DEV/QC/UAT)
• Configure UserGroups to manage privileges appropriately at the category level– – “Developers can access – Development”
  – “QR/QT can access QC”

QC/UAT PROCESS

• You can query iReview metadata
• Business rule verification by checking

– “Panel names, item names”
– “Object location e.g. Public, private or usergroup”

• Use of SQL to query iReview objects metadata
• The information in CONTENTBLOCK is parsed to get
  additional metadata information for a particular iReview
  object
• Define a detailed QC checklist for each object in the Global Library

• Maintain a lessons learned document (knowledge base) to improve the development process

• Continuously improve processes by collecting Metrics

  – Development time

  – QC time

  – Rework time

Advance Functionality

• Deploy reports with dynamic Filter values
• Filter values are not static and change during trial conduct
• Deployment for non-technical end-users
• Provide easy access to report
• Create Lookup table(s) in the backend

• Populate Lookup table(s) with study specific Filter values

• Using “Filter Output” in IR, add appropriate nested queries to the WHERE clause

• The use of ImportSQL, more complex dynamic filtering so no need to hardcode values in the front end

• Saves development time by avoiding the creation of study specific filters and increases re-usability

• Flexibility to activate/inactivate filter values via backend

Import SQL

• Modify an Import SQL panel by adding more items will not impact existing reports already using this Import SQL

• Import SQL has a limitation with max of 2000 characters (will result in the error below)

A workaround would be to create a stored procedure or a view

Patient Selection Criteria

• Modifying a PSC has no impact on already saved existing reports using this PSC

Object Specifications window

• Removing Objects (missing folders)
  – When all the objects are removed from a folder in the Object
  Specifications window, the folder with no objects will be hidden but
  not removed
  e.g. Drug Safety ..> All AEs ..> SAE Reports ..>SAE reconciliation
• Removing all objects under “SAE Reports” folder will result in the “SAE Reports” folder being hidden
• The workaround would be to use the Category section of Object Management tool to remove these hidden folders

Navigating iReview Windows

• If you have hundreds of saved objects, typing the first few letters (similar to Windows Explorer) will help with easy scrolling and navigation in the Object Specifications window

Reference: Integrated Clinical Systems, Inc.