RWD Lineage
To generate reliable RWD in SDTM for regulatory use, additional information is needed to audit source data and quantify the information loss and performance of data transformations to calculate error bounds. RWD Lineage, will be a standardized and comprehensive representation of source data containing lineage for each source patient data element that specifies either:
- The location of the element in the output analysis dataset (Positive Lineage).
- That the element was not used in the output analysis dataset (Negative Lineage).
Furthermore, RWD Lineage will be represented in a standard metadata model that can be used along with SDTM to support the use of RWD with SDTM. This standardization will allow lineage to be combined across disparate data sources and will enable the unification of downstream tools, workflows, and analytics for validation and audit activities.
How to Participate
We invite your organization to participate in this collaborative initiative. Please visit the Participate tab to learn more.
RWD Lineage
We are looking for volunteers with expertise and skills in the following areas:
Essential Skills
- All volunteers must have JSON and/or XML knowledge.
- Experience working with RWD.
- Experience with CDISC standards such as CDASH or SDTM.
“Plus” Skills
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The expected time engagement is -----.
Please join us!
To participate, please complete our Volunteer Form and indicate the RWD Lineage as the Standards Development team.