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Meeting NameMeeting DocumentationMeeting DateMeeting TimeDescription
CDISC Overview Webinar Session 1 CDISC Overview Webinar Slides March 7, 201910:00am - 11:30am ESTDescribe the CDISC organization and purpose

Explain the high-level principles of CDASH, SDTM and Controlled Terminology (CT) standardization

Demonstrate finding and downloading the standards documentation, including how to create a CDISC online account and access SHARE documentation

Brief demos of ALS to show how CDISC standards are built in
CDISC Overview Webinar Session 2CDISC Overview Webinar SlidesMarch 7, 20193:00pm - 4:30pm ESTDescribe the CDISC organization and purpose

Explain the high-level principles of CDASH, SDTM and Controlled Terminology (CT) standardization

Demonstrate finding and downloading the standards documentation, including how to create a CDISC online account and access SHARE documentation

Brief demos of ALS to show how CDISC standards are built in
CDISC SME Meeting
March 20, 20192:00pm - 4:00pm ESTCANCELLED due to lack of agenda items
Variable Naming, NSV Session 1Variable Naming, NSV SlidesMarch 28, 201910:00am - 11:30am ESTVariable naming conventions

Non-standard variables
Variable Naming, NSV Session 2Variable Naming, NSV SlidesMarch 28, 20193:00pm - 4:30pm ESTVariable naming conventions

Non-standard variables
Controlled Terminology Webinar Session 1Controlled Terminology SlidesApril 2, 201910:00am - 11:30am ESTUsing Controlled Terminology
New Term Requests
Controlled Terminology Webinar Session 2Controlled Terminology SlidesApril 2, 20193:00pm - 4:30pm ESTUsing Controlled Terminology
New Term Requests
CDISC SME Meeting
April 8, 20192:00pm - 4:00pm ESTCANCELLED due to lack of agenda items
CDISC SME Meeting
April 16, 20193:30pm - 5:30pm ESTCANCELLED due to lack of agenda items
Custom Domains Webinar Session 1Custom Domains Webinar SlidesApril 17, 201910:00am - 11:30am ESTCustom Domains
Custom Domains Webinar Session 2Custom Domains Webinar SlidesApril 17, 20193:00pm - 4:30pm ESTCustom Domains
Using QRS Supplements Webinar Session 1Using QRS Supplements SlidesMay 3, 201910:00am - 11:30am ESTUsing QRS Supplements
Using QRS Supplements Webinar Session 2Using QRS Supplements SlidesMay 3, 20193:00pm - 4:30 ESTUsing QRS Supplements
CDISC SME Meeting
May 10, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
Validating Submission Data Webinar Session 1Validating Submission Data SlidesMay 20th, 201910:00am - 11:30am EST

Explain the use of validation tools to support FDA submissions
Review different sources for validation rules on which the validation tools are based
Good practices for reviewing and dispositioning validation report results
Prepare a Study/Analysis Data Reviewer’s Guide
Understand what validation tools can and cannot do

Validating Submission Data Webinar Session 2Validating Submission Data SlidesMay 20th, 20193:00pm - 4:30pm ESTExplain the use of validation tools to support FDA submissions
Review different sources for validation rules on which the validation tools are based
Good practices for reviewing and dispositioning validation report results
Prepare a Study/Analysis Data Reviewer’s Guide
Understand what validation tools can and cannot do
Overview of FDA Submission Process Webinar Session 1Overview of FDA Submission Process SlidesMay 22, 201910:00am - 11:30am ESTFDA Submission Process
Overview of FDA Submission Process Webinar Session 2Overview of FDA Submission Process SlidesMay 22, 20193:00pm - 4:30pm ESTFDA Submission Process
CDISC SME Meeting
May 24, 20192:00pm - 4:00pm ESTCANCELLED DUE TO LONG HOLIDAY
CDASH/SDTM/ADaM Webinar Session 1CDASH/SDTM/ADaM SlidesMay 28, 201910:00am - 11:30am ESTHow to get from CDASH to SDTM to ADaM
CDASH/SDTM/ADaM Webinar Session 1CDASH/SDTM/ADaM SlidesMay 28, 20193:00pm - 4:30pm ESTHow to get from CDASH to SDTM to ADaM
Using TA User Guides Webinar Session 1Using TA User Guides SlidesMay 29th, 201910:00am - 11:30am ESTUsing TA User Guides
Using TA User Guides Webinar Session 2Using TA User Guides SlidesMay 29th, 20193:00pm - 4:30 ESTUsing TA User Guides
CDISC SME MeetingReview Standard AE Form (CTSU_AE)July 9, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME MeetingSME SlidesAugust 23, 20191:00pm - 3:00pm EST
  • Review and discuss additional SDTM Implementation Guides
  • Review and discuss Codetable Mapping Files
  • Q&A
FA Domain vs Supplemental Qualifiers FA Domain vs Supplemental QualifiersMay 19, 20202:00pm - 4:00pm EST

LPO Webinar Series: CDASH Conformance Session 1

CDASH Conformance Session 1January 14th, 20211:00pm - 2:00pm EST

Using CDASHIG Domains to find the right Rave Form in the GLIB ALS

LPO Webinar Series: CDASH Conformance Session 2CDASH Conformance Session 2January 14th, 20211:00pm - 2:00pm EST

CDASH Conformance Rules for Naming EDC Variables

LPO Webinar Series: CDASH Conformance Session 3LPO Webinar Series: CDASH Conformance Session 3February 10th, 20211:00pm - 2:00pm ESTCDASH Conformance Rules for Using Controlled Terminologies
LPO Webinar Series: CDASH Conformance Session 4LPO Webinar Series: CDASH Conformance Session 4February 25th, 20211:00pm - 2:00pm ESTCDASH Conformance Rules for CRF Question Text and Prompt












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