Sample Submission Validation Process

FDA would like to assist sponsors and applicants who have not previously submitted an eCTD and/or standardized study data, and who are planning a submission to the FDA. We offer a process to validate sample eCTD submissions and standardized study datasets. You must have an NDA, IND, BLA or ANDA number and plan to submit an actual submission 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.

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 Capability Team at ESUB-Testing@fda.hhs.gov to request a Sample Application Number.

   • Please include the following in your email:
     1. Contact’s Name - this will be the main contact during the sample submission phase
     2. Contact’s Company Name
     3. Contact’s Mailing Address
     4. Contact’s Phone Number
     5. Contact’s Email Address
     6. NDA, IND, BLA, or ANDA number
     7. Planned Date of Official Submission

     8. Description of test requested, including application type (e.g., eCTD/IND, ANDA, NDA, BLA, or DMF; 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 Capability Team will contact you and assign a Sample Application Number, along with additional instructions.

2. Submit your sample submission according to supported specifications
   Please do not submit eCTD / dataset samples via the Electronic Submissions Gateway. Sample submissions should be addressed and submitted according to the instructions you will be provided with your Sample Application Number.

   If you are testing an eCTD submission, please review the recommended contents of the sample submission and the eCTD Submission Standards. For standardized datasets, please review the appropriate CDISC Implementation Guide (IG) and FDA supported version(s). Please consult the Study Data Standards Resources web page for information on currently accepted data standards and related resources: Study Data Standards Resources.

   The Electronic Submissions Capability Team will process your sample submission and validate 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 feedback, highlighting the errors found during the processing of the sample submission.

   For standardized study data, please limit your sample submission to one of each data standard: SEND, SDTM/ADaM. Each standard should include 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. OpenCDISC Community), along with any additional observations by the Electronic Submissions Capability Team.

3. Resolve technical issues following FDA feedback
   Sponsors and applicants should review FDA's comments and correct all eCTD and 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 eCTD format and / or 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.

For additional information, contact the Electronic Submissions Capability Team 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.