The following documents provide basic information about the upcoming changes to the Form I file format:
Overview of Form 1 Changes, 03.2012 (PDF: 104KB/1 page)
The following data dictionaries describe the requirements for the Form I, Form II and clinical data file formats:
Form I Data Dictionary 03.01.2013 (PDF: 279KB/24 pages)
Form II Data Dictionary 9.10.2010 (PDF: 526KB/71 pages)
Clinical Data Dictionary 12.13.2011 (PDF: 252KB/22 pages)
Data files must be submitted using the appropriate Excel templates:
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