FAQs

	Presentations FAQ FDA Welcome XForms

	FAQs
	IMPORTANT INFORMATION
	Q1. How can I Download and work with XForms on my Desktop ? A. After ensuring that all of the correct prerequisites are met for your browser, and MozzIE is installed and operating correctly, follow these general steps to open up and work with an XForm locally: After login, go to the “XForms” page and click on button “Download XForms”. You will be re-directed to a page with a link titled “Download Here”. Click on this link. You will be prompted to open or save the file named “XForms_Templates.zip”. Choose to save the folder in location on your machine. After the file is saved, navigate to the newly downloaded folder, right click on the compressed folder “XForm_Templates” and select “Extract All” or “Unzip” (IMPORTANT), depending on your software. You will be prompted to save the extracted files to a new location. If the folder is not automatically created and named for you, create a folder and extract all of the files to this location. Navigate to the newly un-zipped folder and right click on it. Please make sure that the folder is available to your local user account, the attribute "read only" is unchecked, and that these permissions are applied to all of the folders contents. Please refer to your machine's software documentation on how to perform this operation. Open the folder and you will then see a "README.txt" file. This will show you the path to each listed XForm. Otherwise open XForm_Templates\SPL_Xform\SPL\XForms and then select the desired XHTML (XForm) document. When opening each form, you may see a list of available programs to open the file with including Internet Explorer and/or Firefox. Highlight the circle indicating this as the program to open the file with and select "Ok". You may be prompted by Windows to "Open" or "Save" the file. Choose "Open". You are now ready to work locally with XForms. Once you are finished, remember to save your file with an explicit ".xml" extension, i.e. "filename.xml". If you want to work with a file you were storing on our server, or one recently saved to your destop, follow the directions above to navigate to the correct Xforms Template and open it, select "Open" from the form, and navigate to the specified xml file and select "Open".
	Q2. I have followed the instructions above, but I am still having issues? A. The most common issue support deals with is educating users on file and browser permissions. We have provided some basic information for Windows users that will aid you troubleshooting local issues here : http://www.globalsubmit.com/xportal/help/Troubleshooting%20XForms%20Locally.pdf. We will add similar instructional troubleshooting for Firefox shortly, but some quick tips for Firefox users include When working with XForms local or online, navigate to "Tools" in the browser's toolbar. Select "Options" and navigate to the "Security Tab". Ensure that you have checked off "Allow XForms to access different domains" (Make sure the FDA and GlobalSubmit domains are added). Another common mistake is to have your XForm plug-in Disabled. Make sure this is enabled by navigating to "Tools" > "Add-ons" > and checking that Xforms support is available and installed.
	Q3. What features are retired ? A. Currently, the ability to add or upload any new files through the site has been retired due to needed site upgrades and usability. XForm Users may still download any existing form they have online, and work with the destop version of the software.
	Q4. How long do I have to download any xml I am currently storing on the server ? A. We will be sending out emails as needed to our users alerting them of any changes.
	Q5. Will this affect how I submit to the FDA ? A. This will in no way affect the process by which you submit any Xform created data to the FDA. This is just an announcement stating you will need to work with XForms locally as the site undergoes changes.
	Q6. How can I work with a form I was not finished with yet ? A. You may log on, download the XForms Software, as well as your file. To download your file, select it and click "Package", from the Package Form screen click "Download XML", save the file to your computer. To work with the file refer to the instructions and information below.
	Q7. What if I dont have the prescribed browser versions you have listed on the homepage ? A. If you are using a different version of Internet Explorer and the MozzIE add-on, you should not have many, if any issues at all, as long as you go over the steps listed below. Note: Turn on Compatability mode for IE8. However, using a later version of Firefox will cause security issues, unless you make certain browser setting chages in addition to those already discussed below and on the login page. It is recomended that you download the prescribed versions of each browser, however, there is information regarding the necessarry changes needed when working in a later version of Firefox, found here, at the bottom of the article. Unless you are adept with Firefox's advanced settings, we highly suggest you simply download the correct version found for free from a number of sites, one of them is http://www.brothersoft.com/firefox-download-111819.html.
	Q8. 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.
	Q9. How do I insert pictures into an SPL file? A. Enter the information about the image in the Observation Media fields. After you successfully entered this information, then place the computer mouse cursor in the location of the section where the image should appear once rendered by the SPL stylesheet. Then choose the image second from the right in the section toolbar. (looks like a landscape) You will then be prompted to select the image. Follow the prompts. Do not forget to save the section in which the image "placeholder" was entered. You will be able to view the image once you export the SPL from the Xforms and place this document in the same location as the image file. NOTE: Blank information in the Observation Media section may prevent the user from adding images. Please open the XML text and remove the blank fields.
	Q10. I reveive an error message and am unable to launch GUIDGen.exe locally? A. Microsoft .NET Framework needs to be installed on your machine in order for GUIDGen to operate. Please install .NET Framework if it is not on your machine. Microsoft .NET Framework Version 2.0.
	Q11. What are the benefits of using XForms to a sponsor organization? A. Some significant benefits include: 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 Reduces the time to prepare and submit by eliminating the need to create paper Supports public health and safety initiatives by allowing the submission of critical data electronically
	Q12. What are the benefits of using SPL to the FDA? A. SPL files improve the efficiency for processing registration and listing information.
	Q13. Where can I find instructions on the SPL XForms? A. FDA published instructions for using the SPL XForms along with the draft guidance document on July 10th, 2008. This has since been updated as of June 6th, 2009. The new link is here http://www.fda.gov/ForIndustry/DataStandards/default.htm.
	Q14. 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.
	Q15. What is the difference between Package 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.
	Q16. Where is my XForm stored? A. The XForms are stored on a secured server online.
	Q17. 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.
	Q18. 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.
	Q19. Is my information secure? A. Your information is held on a secure server and is not accessible by other XPortal users or the FDA.
	Q20. How do I send my completed SPL file to the FDA? A. SPL xml file is submitted to the FDA using the FDA Gateway.
	Q21. When will the FDA start accepting SPL XML files for registration and listing? A. FDA has been accepting SPL XML files for registration and listing submissions in place of paper since July 10, 2008.
	Q22. 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.
	Q23. 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.
	Q24. 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.
	Q25. How can I print a form? A. From the Preview page, choose File -> Print from your browser menu.
	Q26. 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.
	Q27. How do I create a new version of a completed form? A. Click the Add button and then choose to copy an existing form.
	Q28. 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.
	Q29. 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
	Q30. What training is available for XForms? A. The FDA has recently updated it's site. Please refer to http://www.fda.gov/ForIndustry/DataStandards/default.htm for any updates regarding this.
	Q31. What support programs are available for XForms? A. Email support is available at xportal@globalsubmit.com for technical issues. For specific SPL questions and filling out the forms please contact spl@fda.hhs.gov