July 15, 2020
Common Clinical Study Report (CSR) – Basic Word Edition
Document template with common structure and proposed model content, aligned with ICH E3 and CORE. Integrates with CPT and SAP templates.
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Harmonize Process
July 15, 2020
Data Mapping (FHIR-SDTM) for Labs, AEs, and SOA
Mapping of data elements between the HL7 FHIR standard and CDISC SDTM standard for labs, AEs, and SOA to enable interoperability between clinical data standards and healthcare data standards. Output was provided to HL7 to put through public comment.
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July 15, 2020
Digital Data Flow Communications Materials
Materials (DDF Overview, FAQs, CDISC Unified Study Definitions Model, GitHub page, and “What is Digital Data Flow?” video) to provide relevant stakeholders with a clear understanding of DDF’s value proposition.
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July 15, 2020
eTemplates (eCPT, eCSR, eSAP)
The eTemplates are Word templates with technical functions to enable automation and clinical content re-use to downstream documents, processes, and registries.
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July 15, 2020
A Model Approach and De-Identification and Anonymization of Individual Patient Data in Clinical Studies (Paper)
Provides guidance and model approaches for redacting privacy information found in clinical study reports, anonymizing patient level data shared with the broader healthcare community and preparing and distributing layperson summaries to the general public and study participants. Now maintained by PHUSE.
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