This Guide provides technical recommendations to sponsors4 for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs.
The Guide is intended to complement and promote interactions between sponsors and FDA review divisions. However, it is not intended to replace the need for sponsors to communicate directly with review divisions regarding implementation approaches or issues relating to data standards.
Because of the inherent variability across studies and applications, it is difficult to identify all data needed by a review division prior to a scientific regulatory review. We recommend that as early as the pre-IND meeting, sponsors should use the established regulatory process to discuss with the review division the key data necessary to support a submission, the data elements that should be included in each dataset, and the organization of the data within the datasets.
Not every data element included in a standard’s underlying data model is fit for purpose for every trial. The use of the word ‘required’ in this document generally indicates a requirement by the Agency and not any external organization. Any use of the word ‘required’ that would have a different meaning will be explained in the text. For example, the Study Data Tabulation Model Implementation Guide (SDTMIG)6 classifies variables as required, expected, or permissible. This use of the word ‘required’ by the Standards Data Organization does not necessarily indicate an Agency requirement. What data are collected and submitted is a decision that should be made based on scientific reasons, regulation requirements, and discussions with the review division. However, all studyspecific data necessary to evaluate the safety and efficacy of the medical product should be submitted in conformance with the standards currently supported by FDA and listed in the Catalog.
This document applies to submissions to CDER and CBER, however some review offices and multi-disciplinary review teams may have specific technical guidance which provides additional details on preparing and submitting information that may differ from this document. In those cases the specific technical guidance should be followed instead of the information contained herein. If there is a question regarding a specific submission or a particular data standard implementation, the sponsor should contact the review division for specific submission questions or the appropriate contact for data standards issues ([email protected] or [email protected]).