Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  • CDISC Controlled Terminology (available at https://www.cdisc.org/standards/terminology/controlled-terminology), which provides consistent semantics for use across standards.
  • CDISC QRS Supplements (available at https://www.cdisc.org/foundational/qrs), which provide information on how to structure the data in a standard format for public domain and copyright-approved instruments.
  • Version 1.0 of the CDISC TIG Conformance Rules (available at <placeholder, link pending>), with which to assess tabulation and analysis datasets conformance to TIG standards.
  • CDISC eCRF Portal (available at https://www.cdisc.org/kb/ecrf) and Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), which provide a platform from which to download standard CRFs including metadata standardized per ODM-XML. ODM-XML is a standard, vendor-neutral, platform-independent format for representing and exchanging CRF content in electronic data capture (EDC) tools.
  • CDISC Library (available...)
  • Version 2.1 of the CDISC Define-XML (Define-XML, available at https://www.cdisc.org/standards/data-exchange/define-xml/define-xml-v2-1), which provides a metadata standard used to describe any tabular dataset structure.
  • Educational materials, (available at <placeholder, link pending>), to support understanding and use of the TIG v1.0.


...

The TIG is a stand-alone, implementation guide that is not intended to be inherently related to or dependent on other implementation guides published by CDISC. However, for alignment across implementations and efficiency, the TIG was developed leveraging implementation approaches described in the in part by leveraging the currently published CDISC implementation guides listed below. Given this ,   

...

approach, users of these guides will be be familar 

Pagenav