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  • Complete clean Protocol document.
  • IRB Approval.
  • List of Participating Sites (if not included in the protocol document). Multi-site trials require a list of participating sites and contact information.

  • Informed Consent (if not included in the protocol document).

Currently, the system requires you to supply each of your documents as one of the following formats:

  • Microsoft Word (.doc, .docx, or .docm).
  • Adobe PDF.
  • Microsoft Excel (.xls, .xlsx, .xlsm, or .xlsb).
  • WordPerfect.
Note
titleSpecial processing for PDF files

Adobe PDF files require special processing. For information about creating PDFs, refer to Converting Trial-Related Documents to PDFs.

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