When it becomes time to submit a marketing application, individual studies in the program along with their corresponding SDTM datasets, ADaM datasets, and define files, may have been completed 10+ years ago. As newer versions of CDISC standards become supported and/or required by the FDA for electronic submissions, the FDA Data Standards Catalog (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog) is routinely updated.  

Do I need to up-version to the most recent versions of the standard from the current Catalog when preparing to submit clinical study data? In most cases, if the specified versions of SDTM, ADaM, and define files were supported when your study started, you do not need to up-version.  

Okay, but how can I figure this out? Let’s use the rows for ADaM from the current v10.4 of the FDA Data Standards Catalog as an example: 

The version of the standard allowable for an individual study is based on the study start date, which will be in your SDTM TS domain. If the study start date is before ‘Date Support Ends’ date and ‘Date Support Begins’ is not empty, the study can still use the specified version of the standard. If ‘Date Support Begins’ is listed as ‘Ongoing’, it just means the FDA supported that version as of the initial Catalog release date, which was 13Jun2011. In contrast, if the study start date is after the ‘Date Support Ends’, the study can no longer use the specified version of the standard. Therefore, looking at our example above, it would be acceptable to submit clinical study data in ADaMIGv1.0 for a study that started prior to 15Mar2019. 

What if multiple versions of the standard were available during my study? 

If the ‘Date Requirement Ends’ column is empty for a row, the version of the standard indicated by that row is acceptable even for a study starting today. If multiple versions of a standard have a blank value for ‘Date Requirement Ends’, then all of these versions of a standard are acceptable, but it is recommended to try to use the most current version of the standard. For our example above, a study starting 01Jan2019 could use ADaMIGv1.0, ADaMIGv1.1, ADaMIGv1.2, or ADaMIGv1.3. Given that ‘Date Support Begins’ is after the study started, it is not likely this study was completed initially in ADaMIGv1.2 or ADaMIGv1.3. Moreover, it would not be expected that you up-version to one of these versions. In contrast, a study starting 01Jan2021 could use ADaMIGv1.1, ADaMIGv1.2, or ADaMIGv1.3. ADaMIGv1.0 would not be acceptable since the study started after ‘Date Support Ends’ for this version and it also started after the ‘Date Requirement Begins’ for ADaMIGv1.1. The same would be true for a study starting 01Jul2024 even though the study started after ‘Date Requirement Begins’ for ADaMIGv1.2 and ADaMIGv1.3. 

Earlier you said “in most cases”, so how can I be sure? Need help deciding on your data standards versioning and if up-versioning is needed?  Reach out to the submissions experts at Rho to help! 

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.