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1. Extended MDR RequirementsV10.12.docx

   Denise Warzel1/13/2015Revised/reorganized Add Functional Requirements Added content4.1Aras Eftekhari1/14/2015Format edits, Add notes from meetings.4.2Aras Eftekhari1/16/2015Formatting edits from Scrum call.4.3Denise Warzel1/19/2015Added Advisory Group List V54.4Denise Warzel1/25/2015Edits
   caDSR / … / SI MDR Infrastructure Summary Requirements Outline • Apr 20, 2016

2. Copy of Complete Trial Data Elements and Field Formats - Include v4.4 - ALT 2/15/2024 v2.0

   Each row in a batch file is associated with a single record in the database. The first field in each line identifies the name of the table that a record belongs to. Subsequent fields contain different data element values for the same table. The number of fields required in each record, and the values they must contain,
   CTMS - CTRP Documentation • Feb 22, 2024

3. 20190402-LPO-Webinar-ControlledTerminology-V2.pdf

   Terminology is published quarterly ▪ March, June, September and December ▪ Terms may be added, removed or modified (mostly they are added) ▪ Multiple file formats … Basics ▪ Other codelists are more general and can be used for multiple purposes: CDISC Controlled Terminology Basics ▪ Some values may appear in more than one
   NCI CDISC Implementation / … / NCI CDISC Webinars • Apr 03, 2019

4. 20190402-LPO-Webinar-ControlledTerminology.pdf

   Terminology is published quarterly ▪ March, June, September and December ▪ Terms may be added, removed or modified (mostly they are added) ▪ Multiple file formats … Basics ▪ Other codelists are more general and can be used for multiple purposes: CDISC Controlled Terminology Basics ▪ Some values may appear in more than one
   NCI CDISC Implementation / … / NCI CDISC Webinars • Apr 02, 2019

5. Complete Trial Data Elements and Field Formats

   - Include v4.4
   CTMS - CTRP Documentation • Nov 01, 2017

6. Complete Trial Record Data Field Formats

   Accrual Data Field Formats for Complete Trials - Include v4.4
   CTMS - CTRP Documentation • Nov 01, 2017

7. Accrual Data Record Formats for Complete Trials - Include v4.5

   ",,,,,,,,,,,, Special Characters in Accrual Reporting - Include v4.4 ICD-O-3 Study Format for Topography Codes For studies using ICD-O-3 codes, use … codes, separate them by a semi-colon as per the example below. Format:  site code; histology code Code: C64.9;8000/3 Examples: SDC Topography PATIENTS
   CTMS - CTRP Documentation • Jul 06, 2020

8. Accrual Data Record Formats for Complete Trials - Include v4.4

   -03861",873222899999999,05 "PATIENT_RACES","NCI-2011-03861",1,01 Special Characters in Accrual Reporting - Include v4.4 ICD-O-3 Trial Format for Topography … codes). When you use both Topography and Morphology codes, separate them by a semi-colon as per the example below. Format:  site code; histology code Code
   CTMS - CTRP Documentation • Jul 02, 2019

9. CTS2_URI_508_c.pdf

   come in multiple syntaxes and formats, be pulled from multiple servers, etc.) CTS2, not unexpectedly, focuses on one “syntax”— the standard CTS2 representation … have two very different meanings— the first being “Is the current SNOMED CT description of 223658005 correctly formatted and meet the Solbrig HR REST, CTS2
   EVS - LexEVS / … / LexEVS 6.x REST CTS2 Service • Nov 30, 2014

10. LPO-Webinar-CDISC_Overview.pdf

    codelists • Connected to the NCI Thesaurus - many terminologies published and linked • Published in multiple file formats (xls, CSV, ODM, HTML, PDF…) • Additional … Terminology directly from NCI EVS 5 CDISC Standards - Why ▪ Defined, consistently formatted data concepts and structures increases predictability, understanding
    NCI CDISC Implementation / … / NCI CDISC Webinars • Mar 07, 2019