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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published three new FAQs! They have answered two FAQs within Data Submission, the FAQ answered looks at the ‘Upversioning SDTM and ADaM Datasets for Older Studies’ and ‘Annotated CRFs for EDC and eCOA’. They have also answered a FAQ within SDTM/ADaM IG Nuances, that FAQ answered looks at the “ADAE dataset: AESEQ or SRCDOM and SRCSEQ' You can view these questions and see the FAQ's this project has answered so far here. Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. |
The Submitting Real World Data project within the Real World Evidence Working Group, has published a Blog. This Blog post explores possible approaches for submission of real world data to regulatory bodies. Real world data, as defined by the Food and Drug Administration in their guidance, comprises data collected from non-interventional study designs. (1) From project group discussions, ‘claims’ and ‘electronic health records’ comprise most real world data used in providing clinical evidence. Fast Health Interoperability Resources, or FHIR, is a platform used by HL7 for health information exchange. (2) This platform is widely used to exchange healthcare information, as far as claims and EHR data is concerned. As a result, a significant portion of real world data used by the pharma/biotech industry follows HL7-FHIR. |
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The Using OMOP and Other Real World Data Standards to Support Regulatory Submissions, a new project within the Real World Evidence Working Group, is calling for volunteers.
The project includes developing awareness of data standards specific to real-world data to support regulatory purposes. Common data models (CDMs) and taxonomies that are specific to the most commonly used real-world data sources by industry, member companies and regulatory bodies across the globe will be in scope, such as electronic health record sources, patient-reported outcomes, widely accepted claims data sources, and other commonly used observational data. OMOP and the OHDSI community will be the focus, and will be evaluated against other CDMs and standards (such as PCORnet, Sentinel and CDISC).
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 March.
The Kick-Off Meeting for this project will be held 6 March at 14:00-15:00 (GMT) / 9:00-10:00 (EST).The SEND Coding Bootcamp is a new project within the Nonclinical Topics Working Group, is calling for volunteers. The 4-day SEND Coding Bootcamp aims to help those working with SEND datasets become more productive by teaching basic coding and plotting skills. Over the course of a series of separate hands-on coding sessions, participants will learn the basics of programming and plotting using the R programming language. The course will be oriented around SEND datasets and will include reading, writing, plotting, and manipulating SEND datasets stored in .xptformat. Basic knowledge of the SEND standard is expected. No previous knowledge about programming or the R programming language is needed. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 1 April. |
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