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U.S. Department of Health and Human Services

Drugs

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Submit a Sample eCTD or Standardized Data Sample to the FDA

Sample Submission Process

 FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process.  The agency also offers a process for submitting sample standardized datasets for validation.  Sample submissions are tests only and not considered official submissions.  They are not reviewed by FDA reviewers at any time.   Follow the steps below to submit a sample: 

  1. Review the eCTD Specifications and/or Study Data Specifications prior to proceeding. 
  2. Request a Sample Application Number

    To initiate the process of submitting a sample, email the Electronic Submission Support Team at ESUB@fda.hhs.gov to inform us of your plans. When sending an email please include the following:

    a.  Contact Person Name - this will be the main contact during the sample submission phase
    b.  Contact Person's Company Name
    c.  Contact Person's Mailing Address
    d.  Contact Person's Phone Number
    e.  Contact Person's Email Address
    f.   Date When You Plan To Submit An Actual Application
    g.  Description of Sample to be evaluated including application type if known (e.g., eCTD/IND, ANDA, NDA, or DMF; eCTD Cross Application Linking; CDISC/SDTM, CDISC/ADaM or CDISC/SEND dataset)

    Note:  The information you provide in your email request for a sample number should also be provided in the cover letter of your sample.

    Once you have submitted your contact information, a technical representative from the FDA will contact you and assign a number for the sample, along with additional instructions.
  1. Submit your sample submission using the specifications

    If you are testing an eCTD sample, please review the recommended contents of the sample submission.  For standardized data samples, please review the appropriate CDISC Implementation Guide (IG) and version.  You may also find additional information in the Study Data Specifications. 

    The Electronic Submission Support Team will process the sample submission to ensure that it conforms to FDA guidance and specifications as well as ICH specifications and guidelines.  eCTD validation tests include, but are not limited to, DTD validation, verification of file checksums, verification of the presence of the modified file, and identification of missing files.  When testing is complete, you will be provided with a report highlighting the errors found during the initial processing of the sample submission.

    The CDISC/SDTM, CDISC/ADaM or CDISC/SEND validation for sample submissions will produce an error report created by OpenCDISC, along with any additional observations by the Team. 
  2. Resolve any technical issues with the submission

    You should correct all errors identified by the FDA and seek clarification if necessary.

  3. Resubmit the sample submission

    For eCTD, you should resubmit the corrected sample submission in a revised sample submission with the same sequence number.

    After the successful completion of these steps, the submissions should be technically ready to be officially submitted to the Agency. This testing phase does not involve any review of the content of the submission and is intended to only resolve technical issues. For additional information about eCTD sample validation, contact the Electronic Submission Support Team at ESUB@fda.hhs.gov.  For standardized data submission questions, contact EDATA@fda.hhs.gov.