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22, 2019:00am - 11:30am ESTMay 24How to get from CDASH to SDTM to ADaM
Meeting NameMeeting DocumentationMeeting DateMeeting TimeDescription
CDISC Overview Webinar Session 1CDISC Overview Webinar SlidesMarch 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 1
May 3, 201910:00am - 11:30am ESTUsing QRS Supplements
Using QRS Supplements Webinar
May 3, 20193:00pm - 4:30 ESTUsing QRS Supplements
CDISC SME MeetingMay 10, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week beforeOverview of FDA Submission Process Webinar
May 10FDA Submission ProcessOverview of FDA Submission Process WebinarMay 22, 20193:00pm - 4:30pm ESTFDA Submission ProcessCDISC SME Meeting, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week beforeCDASH/SDTM/ADaM WebinarMay 28, 201910:00am - 11:30am ESTHow to get from CDASH to SDTM to ADaMCDASH/SDTM/ADaM WebinarMay 28, 20193:00pm - 4:30pm EST
Validating Submission Data Webinar Session 1
July 9May 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 2
July 9May 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
May 22, 201910:00am - 11:30am ESTFDA Submission Process
Overview of FDA Submission Process Webinar
May 22, 20193:00pm - 4:30pm ESTFDA Submission Process
CDISC SME Meeting
July 9May 24, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDASH/SDTM/ADaM Webinar
May 28, 201910:00am - 11:30am ESTHow to get from CDASH to SDTM to ADaM
CDASH/SDTM/ADaM Webinar
May 28, 20193:00pm - 4:30pm ESTHow to get from CDASH to SDTM to ADaM
Using TA User Guides Webinar
July 10thMay 29th, 201910:00am - 11:30am ESTUsing TA User Guides
Using TA User Guides Webinar
July 10thMay 29th, 20193:00pm - 4:30 ESTUsing TA User Guides
CDISC SME Meeting
July 9, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
July 23, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
August 6, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
August 20, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
September 3, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
October 1, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
October 15, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
October 29, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
November 13, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
December 3, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before
CDISC SME Meeting
December 17, 20192:00pm - 4:00pm ESTPre-planned agendas based on requests the week before

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