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  6. Submit a Standardized Data Sample to FDA
  1. Electronic Regulatory Submission and Review

Submit a Standardized Data Sample to FDA

CDER would like to assist sponsors and applicants who have not previously submitted standardized study data and who are planning a submission to CDER. We offer a process to validate sample standardized study datasets. You must have an NDA, IND, BLA, ANDA, or DMF number and plan to submit an actual submission with standardized study data to the FDA within 12 months of your sample request. Sample submissions are not considered official submissions and are not reviewed by FDA reviewers at any time.

When testing is complete, you will be provided with feedback, highlighting the errors found during the processing of the sample submission.

Sample Submission Validation Process

Please follow the steps below to submit a sample submission:

1. Request a Sample Application Number

To initiate the process of submitting a sample submission, notify the electronic submissions staff at ESUB-Testing@fda.hhs.gov to request a Sample Application Number.

Please include the following in your email:

  • Contact’s Name - this will be the main contact during the sample submission phase
  • Contact’s Company Name
  • Contact’s Phone Number
  • Contact’s Email Address
  • NDA, IND, BLA, ANDA, or DMF number
  • Planned Date of Official Submission
  • Description of test requested, including application type: CDISC/SDTM, CDISC/ADaM or CDISC/SEND dataset

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

Once you have submitted your request and your contact information, a representative from the electronic submissions staff will contact you and assign a Sample Application Number, along with additional instructions.

2. Submit your sample submission according to supported specifications

Sample submissions should be submitted through the Test Electronic Submissions Gateway (WebTrader (fda.gov)) according to the instructions you will be provided with your Sample Application Number.

If you are testing a standardized dataset submission please review:

Please limit your sample submission to one study for each data standard: SEND and SDTM/ADaM.

Your sample submission will be validated that it conforms to the standard including the corresponding data definition file (define.xml).

The validation for sample submissions will produce an error report that was created by a publicly available free validator (e.g. Pinnacle21 Community), along with any additional observations by the electronic submissions staff.

When testing is complete, you will be provided with feedback, highlighting the errors found during the processing of the sample submission.

3. Resolve technical issues following FDA feedback

Sponsors and applicants should review FDA's comments and correct all data issues identified before making an actual submission to FDA. If there is an explanation for a data issue, it should be documented in the study data reviewer’s guide. Do not resubmit any sample information after you have received results from FDA as it will not be further evaluated.

4. Submission and Study Data Validation Support

The sample submission validation process is limited to sponsors and applicants who plan to submit electronic standardized regulatory submissions using standardized study data. The validation of sample submissions does not involve scientific review of the content and is only intended to address conformance to FDA supported electronic submission and data standards.

Contact Information

For additional information, contact the electronic submissions staff at ESUB-Testing@fda.hhs.gov.

Please note: Your point of contact will be notified when the submission is received. Generally, feedback is provided within 30 days of receipt of the sample submission, except during periods of high volume.

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