SDTM



Public Review - SDTM

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.



Statement:

Coordinate across standards teams and within SDS. Refer to guiding priniciples, published models, implementation guides (IGs), and therapeutic area user guides (TAUGs) when debating how to model data.

Rationale:

Decision consistency during consultation and development leads to the production of higher quality products. Inconsistent decision making leads to incorrect usage or inconsistent use of standards. This, in turn, leads to confusion within the user community.

Key Benefits:

Ensures that the IGs, conformance rules, and TAUGs are consistent. Facilitates alignment of decisions made by different foundation and therapeutic area teams.

Actions you can take:
  • Follow published rules
  • Be mindful of precedent setting
Statement:

Provide timely support for developing new projects and when teams approach SDS for consultation.

Rationale:

Timely support during consultation and development leads to the production of higher quality products.

Key Benefits:

Allows predictability and alignment with project timelines and publications.

Actions you can take:
  • Be accountable to complete support steps for given projects and consultation.
  • Read pre-reads as available for full-team meeting.
  • Bear in mind time provided for a topic of discussion.
  • Determine short- and long-term solutions as needed.
  • Form sub-teams as needed to address issues, but set goals and time limits for the decisions to be made.
Statement:

Coordinate across standards teams and within SDS. Be mindful of the impact of changes to the SDTM and SDTMIG and other CDISC standards.

Rationale:

Be aware of the impact of change to implementers before suggesting updates. Significant alterations to the SDTM and SDTMIG used by multiple user communities should be communicated to all stakeholders.

Key Benefits:

Decreases the amount of changes the user community has to implement, decreases the cost in time and money of versioning, and decreases the introduction of errors within company standards. This also minimizes unnecessary or unproductive changes.

Actions you can take:
  • Bear in mind the processes in place for requesting new domains or changes to the standard. 
  • Refer to the SDS Decision Tree for the appropriate steps to follow when considering new activities (e.g, an idea, a new project or proposal).
  • Change requesters should always check the most recent model, IG, and non-standard variable registry before submitting change requests.
  • Change requesters should check with the appropriate foundational teams to determine impact. Feedback should be solicited from all foundational teams.