CDISC SDTM Clinical Trial Data Submissions to the FDA: Frequently Asked Questions

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

18 December, 2019

Sofpromed CDISC

What is SDTM?

SDTM stands for “Study Data Tabulation Model”, and is a CDISC standard to structure (tabulate) clinical trial data to be submitted to regulatory authorities such as the Food and Drug Administration (FDA) of the United States.

What is the difference between SDTM and CDASH/ADaM?

SDTM, CDASH, and ADaM are all Clinical Data Interchange Standards Consortium (CDISC) standards. 

However, while SDTM focuses on providing a standard data tabulation model for regulatory submissions, CDASH (Clinical Data Acquisition Standards Harmonization) defines a standard manner to collect data at the eCRF (electronic case report form) or EDC (electronic data capture) level. 

On the other hand, ADaM (Analysis Data Model) specifies dataset and metadata standards for the generation, replication, and revision of clinical trial statistical analyses, as well as traceability among analysis results and data represented in SDTM.

Why is SDTM important for FDA data submissions?

SDTM is a data submission standard required by the FDA of the United States. Then, clinical trial sponsors must prepare and submit their data to the FDA in SDTM format.

Study data standards apply to the following submissions to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER):

  • Commercial Investigational New Drug (IND) applications (products to be commercially distributed)
  • New Drug Applications (NDAs)
  • Abbreviated New Drug Applications (ANDAs)
  • Biologics License Applications (BLAs)
  • All subsequent submissions to these applications, including amendments, supplements, and reports

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. 

Clinical trial sponsors can obtain additional information by looking at the FDA Guidance on Standardized Data. 

Is SDTM always mandatory for FDA submissions?

Yes. Sponsors whose clinical trials started after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog. The current FDA Data Standards Catalog specifies the use of CDISC standards.

Can data be adapted to meet the SDTM standard once the trial has started and even when it is in an advanced stage?

Yes. The data generated in a clinical trial, even after a long time after its initiation, can still be formatted to meet the SDTM standard. However, this may be quite challenging and is not an ideal scenario, as SDTM implementation should be considered before the study design.

What are the benefits of using SDTM and CDISC standards in general?

Using SDTM, and CDISC standards in general, provides several advantages, including increased efficiency, improved data quality, optimized processes, and better sharing of information. In addition, submitting standardized data helps regulatory reviewers receive and review submissions more effectively.

You can watch the following video to learn more about CDISC standards:

Who can help me with the preparation of SDTM-compliant data for my clinical trial?

Many companies (e.g. CROs) with data management capabilities can help clinical trial sponsors to implement the SDTM standard. Sofpromed, a full service CRO, offers advanced data management and statistical programming services to support sponsors in their FDA data submissions.

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com