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The CDISC ODMViewer (v.1.1)
What is it ?
Viewing Study Events information
Viewing all available forms
Clinical data information by ItemGroup
Creating and visualizing subsets
Saving views as PDF
New features of version 1.1
Tailoring with your required functionality
Pricing
Download the evaluation version
The ODM Viewer is the first tool on the market to visualize CDISC ODM 1.2 or 1.3 files in a very user-friendly way.
The data are visualized as neatly ordered HTML tables with hyperlinks and with easy navigation through the whole contents of the ODM file.
This means that the user never sees any XML !
For those knowing the tool, the ODM Viewer works similarly to the old PHT CDISC Viewer (which was however never adapted for CDISC ODM 1.2)
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How it works
After loading an ODM (1.1, 1.2 or 1.3 version), it displays the structure as a tree (left side pane), which the user can expand or collapse. If one
of the leafs of the tree is clicked, the corresponding data is collected from the ODM file and visualized in one or more tables (right pane). |
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For example, a full overview in tabular form of all study events (i.e. visits) described in the ODM file can be generated by expanding the tree
to the correct metadata version under Studies, and clicking the "Study events" leaf node. This then shows that there are two Study Events scheduled, with all the
available information about them, and with hyperlinks to additional information, i.e. which forms are used and in which order they shoud be used.
Enlarged screenshot ... |
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Similarly, by clicking on the "Forms" leaf node, a list of all available forms, whether they are repeating, which Item Groups they have, etc., is displayed.
As can be seen both the IDs of the forms as well as their assigned name is shown. The ODM terminology is as much as possibly hided for the user, so that
also users that are unknown to the structure of the ODM and its element and attribute names can use the ODMViewer very easily. For ease of navigating between tables, hyperlinks are provided. Enlarged screenshot ... |
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When scrolling in the HTML view, one can easily return to a previous scroll position using the navigation buttons near the bottom of the screen. This is a functionality that even commercial browsers do not provide. |
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For the Clinical Data, the software lists all the data by Item Group. It automatically finds all the available ItemGroup's in the ClinicalData section of the ODM file, collects the data for them, and shows them as a list in the left pane. The user can then choose for which Item Group he/she wants to see the data, which is then nicely formatted into tables. Also the Audit Records information, Signature information, and if present, the Annotations are shown. |
 The Demographics tables - a table is created for each subject / form combination. |
 If present in the file, also the Audit Record information is displayed |
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Working with subsets Special functions can easily be added to the application. By default, functionality has already been added to select specific studies, metadata versions, sites and investigators, subjects, visits (study events), forms and item groups. As such, an infinite number of subsets can be created for which the data is then visualized in a number of tables (one for each Item Group). |
 The "Subsets Panel" to make the selections |
 and the resulting set of tables. |
Some of the new features of version 1.1 are:
We have constructed the ODMViewer so, that additional functionality can easily be added. This can be already existing functionality, like the one for adding and verifying electronic signatures, or the CDISC ODM Checker, but it can also be functionality that is created according to your own specifications.
As such the ODMViewer can easily be extended into a veritable ODM Workbench, tailored to the needs of your companyA single copy of the ODMViewer is available for the price of Euro 750 (US$1100), when your company is a CDISC member. Non-members pay Euro 1000 (US$1500).
For larger quantities, or for a company license, please ask for a quote (considerable discounts apply).
If you would like a customization for your company, or would like additional functionality, please contact us.
If you would like to try out the ODM Viewer before you decide to buy a license, you can download an evaluation version of the software (9 MB).
After you have download and unzipped the distribution, look for the file ODMViewer_installation_instructions.pdf, or download the installation instructions from here. You will also need a temporary license file. Please just send us an e-mail with your full name and address.
