Tag Archives: JReview

Top 3 Posts at (EDC Developer)

Fist, I would like to thank everyone who has read articles posted at {EDC} Developer. Especially, my colegas and friends from India. The highest reading and hits have come from people living in India.

New to the industry? Want to get in as clinical data manager or clinical programmer? Looking for a particular topic or an answer to a question? check the contact me section.

Here are the top most searched articles this past few months:

1- Data Management: Queries in Clinical Trials

2- How to document the testing done on the edit checks?

3- Why use JReview for your Clinical Trials?

Others most read articles:

Role of Project Management and the Project Manager in Clinical Data Management

4 Programming Languages You Should Learn Right Now (eClinical Speaking)

Data Management Plan in Clinical Trials

For the search term used to find {EDC} Developer:

1-types of edit checks in clinical data management

2-Rave programming

3- pharmaceutical terminology list

4-seeking rave training (better source is mdsol.com)

5- edc programmer

6-central design tips and tricks

Thank you for reading!

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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.

Why use JReview for your Clinical Trials?

Issues with existing database query tools:
– Limited resources for current database query tools (Crystal Report, SQLServer, etc.)
– Custom reports in SQL Servers required validation
– Reports are not globally accessible.

Why chose Integrated Review?

  • Offers flexibility to the users when viewing the data
  • Users can create their own reports without validation
  • Provides a way for Clinical Data Managers to have real-time access to query and browse clinical patient data in our databases
  • IReview/JReview can then reference the “nonnative” database object using the Foreign Panel and/or ImportSQL capabilities. The result is that the user can remain working in one environment and reference the data that is located in other environments.
  • Easy to setup – no programming, no data extraction or data manipulation required.
  • Generate PDFs directly – for all patients selected

“I-Review would be used solely for cleaning data – providing highest data integrity prior to stats analysis.”

Why use a Patient Profile

  • When you want to review data from multiple Tables for a single subject Describe the factors or characteristics that are deemed critical to the success of a project, such that, in their absence the project will fail.
  • Very powerful when used with a Cross Tab report to provide the detail needed to investigate a finding.
  • Special case review such as SAEs or event adjudication.
  • Provides data to support the narrative writing team.

Advantages

  • Easy to build
  • Excel exportable file
  • Multiple subjects in a single report

Limitations

  • Poor readability
  • Output limited to 13 columns of data per row
  • Can’t edit column headers
  • Page header data is limited to 3 items
  • There is no option to use free text in the header or footer

Formatted Style
Advantages

  • High readability PDF style output which also prevents the manipulation of data
  • Free text entry for page header and footer can be used to add key notations to the report
  • Column header text can be edited to enable use of intuitive labels instead of database codes
  • Scheduling feature allows for running batches of patients and exporting outputs as a group
  • Bookmarks in output allow for quick navigation to data
  • Limitations
  • Creation of profile can be slow in the tool use scheduler
  • Can be very time consuming to develop (use a global template)

Object Storage

  • Private (local accessible by the user only) vs Public (accessible by all users)
  • Usergroup (i.e. CDS, CDM, Clinical, biostat, etc)

Object Level

  • Study (at least one view (object) at the study level)
  • Project (a mixture of project and global level and available across the entire project)
  • StudyGroup
  • Global

Keys to Success

  • Think about your audience – Clinical or Data Managers
  • The goal is to provide a report which is easy to read
  • Develop a “template” using standard modules and data items
  • Establish standard formats all parts of the report
  • Font size
  • Text alignment
  • Page margins
  • Use the same formatting for protocol specific elements


Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.