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New Deliverable Date for CDISC Implementation

All CTEP IND Studies activated on or after March 1, 2020 shall be CDISC compliant (submit to FDA in SDTM Format).

• Studies activated prior to February 28th, 2020 do NOT need to be CDASH compliant but LPOs are encouraged to launch CDASH compliant studies prior to the March 1st deadline, if possible.
  • Waivers will only be considered by the NCI for truly extenuating circumstances that meet both of the following criteria
  • The justification is for something beyond LPO control
  • AND the activation date was anticipated to be prior to January 1, 2020.

July 31, 2019:  NCI CDISC Deliverables Release

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• CTSU CDISC GLIB ALS v1.0 20190731
• CTSU CDISC GLIB ALS v1.0 Difference Report BETA-FINAL 20190731
• CTSU CDISC GLIB ALS v1.0 Release Notes FINAL 20190731

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Three CDISC CTSU Standard Forms documents are attached for the July 31, 2019 release;

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