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.

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