What is SDTM?
SDTM (Study Data Tabulation Model) is one of the requirements for data submission to the FDA (U.S) and PMDA (Japan). To facilitate data collection, management, analysis, and reporting procedures, SDTM offers a standard for organizing and presenting data. Implementing SDTM helps with data warehousing and aggregation, encourages mining and reuse, makes sharing easier, supports due diligence and other crucial data review tasks. It enhances the regulatory review and approval process. Additionally, SDTM is utilized in pharmacogenomics and genetics investigations, medical devices, and non-clinical data (SEND).
What is the role of SDTM?
The SDTM format is the accepted format for tabulation data submission to the FDA. The SDTM was designated in 2011 as the standard format for reporting data for non-clinical trials after being declared the standard format for data submission for clinical research in 2004. Data managers must become proficient in SDTM to ensure seamless data submissions, because clinical and nonclinical data submissions must follow the SDTM standards.
PointCross releases Xbiom™ SDTM Generator
PointCross provides dashboards for curating and integrating auxiliary studies and biomarker assays (CT). In order to automatically produce SDTM datasets with the chosen Implementation Guide (IG) and Controlled Terminology from EDC and eCRF data stored in a F.A.I.R. Unified Data Model (UDM).
SAP prescribes analysis on periodic EDC data lockouts; however, translational requirements are frequent or ad hoc to fulfill the analysis of bench to bedside data. To keep an ever fresh and curated data picture of the trial in the UDM, it is simple to continuously curate new patient and visit data using Xbiom.
What is the difference between SDTM and ADaM?
Two important standards are supported by CDISC: SDTM (Study Data Tabulation Model) and ADaM. (Analysis Data Model). Although the adoption of CDISC standards may increase development costs, you can reduce those costs by choosing the appropriate technology and implementation strategy. SDTM and ADaM datasets in the adoption of CDISC standards not only simplifies procedures but also stimulates innovation, efficiency, betters data quality, reduces costs, and boosts predictability.
In comparison to SDTM and SEND, CDISC’s Analysis Data Model (ADaM) is a little different. Although the model is less prescriptive, it still comprises a core model and an implementation guide. Within specific limitations established by the model, more variables may be added. This provides a level of standardization that enables it to be easily understood by reviewers, while giving it the flexibility to be used for any type of study.
SDTMIG – How is it different from SDTM?
SDTMIG (Study Data Tabulation Model Implementation Guide SDTM IG) is designed to provide guidance for the organization, structure, and format of standard clinical trial tabulation datasets, whereas SDTM provides a standard model for organizing and formatting data for human and animal trials. Although not limited to usage in regulated submissions, it was created to support data submitted to regulatory authorities like the US Food and Drug Administration (FDA). As stated in the FDA’s Data Standards Catalog for NDA, ANDA, and some BLA submissions, SDTM is one of the standards that sponsors are required to use.
With reference to a particular SDTM model, a Study Data Tabulation Model Implementation Guide (SDTMIG) is created. SDTM, on the other hand, builds on each new release of the model. The models can therefore be used with older hardware. For instance, SDTMIG-AP version v1.0 was created with SDTM version v1.4 in mind, but it can be used with SDTM v1.7 in a submission.
SDTM Domain Classes
The UDM performs a number of key functions:
- Find, access, and choose the data for stratified cohorts.
- Identify cohorts or subjects for analysis and produce TFLs as needed.
- Generate SDTM on demand with chosen IG and CT.
Biometricians, Biostatisticians, and Clinical Ops can all benefit from the Xbiom SDTM generator. Within 24 hours, a typical read cycle of the EDC and biomarkers can result in a curated UDM and SDTM. When used with the eDataValidator, which is also part of Xbiom, this can save time, become a valuable resource for the biometrics team, and aid in the quality checking and validation of the data.