• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Guidelines for requesting waiver to current supported clinical study data standard versions

 

At this time, submitting study data in standardized format is voluntary, so a waiver is not needed to submit study data in non-standardized format.  If standardized study data is submitted, it should use one of the currently supported versions identified in the Catalog below.

 

The currently supported versions of clinical study data standards are identified in the FDA Study Data Standards Catalog. 

Sponsors who submit standardized study data using a standard that is unsupported or retired, should request a waiver by sending an email to CDER-edata@fda.hhs.gov.  The subject line of the email should start with "waiver request" and contain the following:   

  • Contact person’s name (this will be the main contact)
  • Contact person’s company name
  • Contact person’s mailing address
  • Contact person’s phone number
  • Contact person’s email address
  • Relevant submission types and numbers
  • The standard(s) being used and a justification
  • A description of the submitter’s plan to become compliant with the guidance, including relevant timeframes.
     

The clinical study data submission coordinator will coordinate with the applicable review division, and contact the requestor concerning the status of the waiver request.