According to the Study Data Technical Conformance Guide (October 2024), sponsors should prepare a document called the study data standardization plan (SDSP) for each of their development programs to describe the submission of standardized non-clinical and clinical study data to the FDA. For New Drug Applications (NDA) and Biologics License Applications (BLA), the SDSP should be located in Electronic Common Technical Document (eCTD) section 1.13.9 General Investigational Plan. For Investigational New Drugs (IND), the SDSP should be located in eCTD section 1.20 General Investigational Plan for an Initial IND.
Sponsors are encouraged to start the SDSP early, even in pre-IND stage, to identify potential standardization issues early in the development process. It should be shared with the FDA during key regulatory interactions and when deemed necessary by either the sponsor or the FDA. The SDSP should then be updated in subsequent communications with the FDA as the development program expands and additional studies are planned. The document is often used as part of briefing packages for pre-NDA and pre-BLA meetings to confirm agreement on what and how study data will be submitted, but can be shared for earlier FDA interactions as needed.
The SDSP contains tabular lists of non-clinical and clinical studies in the development program with details about each study such as protocol number, study title, study type, study status, start date, and standards used for study data. The example below shows the column headings for the table for clinical studies:
- The exchange standards column is meant to detail if legacy, SEND, SDTM, and/or ADaM data will be submitted as well as which versions of these were used.
- The terminology standards column is expected to indicate controlled terminology versions as well as versions of applicable standard dictionaries (e.g., MedDRA).
There is also a section for details for any pooled data to be submitted such as data pool identifier, list of studies included, description of the pool, and standards used. The example below shows the column headings for this section:
In addition, the SDSP contains sections for justifications for non-conformance to supported standards and details around any discussions with the FDA related data standards for this development program, as applicable.
Lastly, for submissions through CBER, an appendix with tables of SDTM domain/variable usage, supplemental domain usage, and proposed analysis is expected.
For more details, PhUSE has a template for the SDSP with completion guidelines, implementation guide, and examples at Study Data Standardisation Plan (SDSP) Package – WORKING GROUPS – PHUSE Advance Hub.
If your development program does not yet have an SDSP, especially if you are nearing, or have already initiated your Phase 3 studies, reach out to the submissions experts at Rho to help you put your SDSP together now!
Hilary Wall, Principal Biostatistician, holds advanced degrees in Statistics and Biomedical Statistics. Since arriving at Rho in 2007, she led the biostatistics and statistical programming teams providing for clinical trials, with a specific focus on late-stage regulatory submissions. She has served as a lead or supporting statistician on upwards of twenty NDAs/BLAs, often working as the primary author of integrated statistical analysis plans and CDISC-compliant integrated analysis (ADaM) specifications for the ISS/ISEs. Ms. Wall also acts as a data standards expert, reviewing and updating study data packages to ensure compliance with the latest FDA requirements, technical rejection criteria, and CDISC/legacy guidelines. She has collaborated with clinical researchers and medical writers in many therapeutic areas, including respiratory, psychiatry, otolaryngology, hepatology, oncology, rare/genetic diseases.