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Q. What are XForms?
A. XForms is an open standard that encourages a style of forms-based data entry. It has been
refered to as the “next generation of Web-based data processing”. It replaces traditional HTML
forms with an XML data model and presentation elements. For detailed information, see
http://en.wikibooks.org/wiki/XForms.
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Q. What are the benefits of using XForms to a sponsor organization?
A. Some significant benefits include:
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Allows the free preparation of FDA compliant submissions for Structured Product Labeling,
Regulated Product Submissions, Individual Case Safety Reports, and stability data, without
the need to purchase software or engage outsourcing partners that would otherwise be required
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Reduces the time to prepare and submit by eliminating the need to create paper
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Supports public health and safety initiatives by allowing the submission of
critical data electronically
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Q. What are the benefits of using XForms to the FDA?
A. XForms will allow the FDA to receive information directly from a sponsor in a standard form that
can be viewed, printed, or imported into a database or other software application. With paper
documents or PDF, this information is time-consuming to upload, analyze, etc.
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Q. What is MozzIE?
A. MozzIE is a plug-in for Microsoft Internet Explorer that allows the display of XHTML + XForms
using the Mozilla Gecko Rendering Engine. You must install MozzIE to use XPortal with IE. MozzIE is
a third party software product that is not supported by GlobalSubmit.
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Q. What is the difference between Download and XForms Download?
A. Download saves a copy of the data you entered into your form in XML format to a selected
location. XForms Download copies the form templates in a zip file to a selected location.
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Q. Where is my XForm stored?
A. The XForms are stored on a secured server online.
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Q. How long will GlobalSubmit retain my information?
A. We have not established any records retention schedule at this point, and although we would
never delete information without working with you first, please keep in mind that we are not under
formal contract to retain your information and you remain responsible for records management.
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Q. How do I get a copy of my XForm to retain for records management purposes?
A. Use the Download feature and store the downloaded file in a document management system or
other secure location.
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Q. Is my information secure?
A. Your information is held on a secure server and is not accessible by other XPortal users or
the FDA.
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Q. How do I send my completed XForm to the FDA?
A. Right now, you submit the form by downloading and attaching to an email. In the future, a
button will be added that will allow you to submit directly to the FDA.
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Q. When will the FDA start accepting XForms?
A. FDA is currently testing several standards and to refer to the FDA’s 5 year plan on when they
will be accepted. To see the plan, go to
http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0481-gdl0001.doc
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Q. What sort of validation is done on my data?
A. At this time, the only validation is performed is through the use of dropdown lists. Other
information is not validated and it is up to you to check for validity.
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Q. Where do I get the DUNS number for my company’s location?
A. Your company probably has an employee who is responsible for the Dunn and Bradstreet DUNS
number assignment. You can call your accounting department for the DUNS number or Human
Resources to identify the DUNS contact for your company.
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Q. Which DUNS number for my company do I use on the XPortal when filling out an SPL form?
A. A Dunn and Bradstreet DUNS Number identifies your companies specific geographical location.
You must use the DUNS number assigned to the specific location for your SPL submission.
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Q. How can I print a form?
A. From the Preview page, choose File -> Print from your browser menu.
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Q. Can I share my forms with my colleagues?
A. You can establish a shared ID that you use to access XPortal, or you can download files to a
location that can be accessed by multiple people. At this time, forms cannot be shared across user
IDs. In the future, we may add a capability to share forms among users affiliated with the
same company.
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Q. How do I create a new version of a completed form?
A. Click the Add button and then choose to copy an existing form.
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Q. Can I compare two forms?
A. If you have a tool that can compare XML files (such as XML Spy) then simply save the two forms
you want to compare (in XML format using the Download button) to a desired location. Then use
the program to compare. You may be able to find a freeware program to compare XML files, or to
experiment with using MS Word 2007.
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Q. I am not able to save forms – what should I do?
A.MozzIE may not be installed properly. Uninstall and reinstall MozzIE 1.8. To uninstall, use
Add/Remove programs from the Control Panel. To install, follow the link on the main XPortal
page: //www.globalsubmit.com/xportal/login.aspx
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Q. What training is available for XForms?
A. Getting started with XForms is quick and intuitive. FDA is presenting a series of training sessions
(see //www.fda.gov/oc/datacouncil/hl7_spl_wg_xform_training_04_09_08.html) for the first
one; more to be announced. GlobalSubmit is currently gathering feedback on what types of more
advanced training would benefit users and managers. If you have ideas or suggestions, please
contact us at xportal@globalsubmit.com.
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Q. What support programs are available for XForms?
A. Please contact us at xportal@globalsubmit.comto discuss your support needs.
We can arrange inexpensive support programs that will help you make the most efficient use of this exciting new tool.
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