Study Data Standards are required in clinical and nonclinical studies that start after December 17, 2016.1 Technical rejection criteria is being added to the existing eCTD validation criteria to enforce the deadlines (see below). FDA will give the industry 30 days’ notice on the eCTD website prior to the criteria becoming effective.
The FDA may refuse to file (RTF) for NDAs and BLAs, or refuse to receive (RTR) for ANDAs, an electronic submission that does not have study data in conformance to the required standards specified in the FDA Data Standards Catalog.
The standards apply to the following types of submissions to CDER and CBER:
- NDAs, ANDAs, BLAs, and all subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect.
- Commercial INDs (for products that are intended to be distributed commercially).
Deadlines: Sponsors whose studies start after December 17, 2016 must use the data standards listed in the FDA Data Standards Catalog for NDAs, BLAs and ANDAs. For Commercial INDs, the requirement starts after December 17, 2017.
Although CDER and CBER can RTF or RTR submissions that do not conform to the required standards, FDA will implement a process to assess high-level study data standards conformance at the time the submission is submitted and validated. The criteria to be used to assess conformance are listed in the tables on page 2. If the submission fails these criteria, it will be rejected and the sponsor will be notified.
Also, a Trial Summary dataset (ts.xpt) must be presented for each study in sections identified below even if the study started prior to December 17, 2016. Nonclinical legacy data submitted in PDF format should be submitted with a TS dataset.
Study data validation WILL APPLY to the following eCTD sections, except the sections noted below:
- 4.2 Study Reports
- 5.3 Clinical Study Reports and Related Information
Study data validation WILL NOT APPLY to the following eCTD sections:
- 4.2.1 Pharmacology
- 4.2.2 Pharmacokinetics
- 220.127.116.11 Genotoxicity
- 18.104.22.168 Reproductive and Developmental Toxicity
- 22.214.171.124 Local Tolerance
- 126.96.36.199 Other Toxicity Studies
- 4.3 Literature References
- 188.8.131.52 Reports of Bioanalytical and Analytical Methods for Human Studies
- 184.108.40.206 Reports of Analyses of Data from More than One Study
- 220.127.116.11 Other Study Reports and Related Information
- 5.3.6 Reports of Postmarketing Experience
Technical Rejection Criteria for Study Data