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Page History
| Meeting Name | Meeting Documentation | Meeting Date | Meeting Time | Description |
|---|---|---|---|---|
| CDISC Overview Webinar Session 1 | CDISC Overview Webinar Slides | March 7, 2019 | 10:00am - 11:30am EST | Describe 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 2 | CDISC Overview Webinar Slides | March 7, 2019 | 3:00pm - 4:30pm EST | Describe 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, 2019 | 2:00pm - 4:00pm EST |
| CANCELLED due to lack of agenda items | |
| Variable Naming, NSV Session 1 |
| Variable Naming, NSV |
| Slides | March 28, 2019 | 10:00am - 11:30am EST | Variable naming conventions Non-standard variables |
| Variable Naming, NSV |
| Session 2 | Variable Naming, NSV Slides | March 28, 2019 | 3:00pm - 4:30pm EST | Variable naming conventions Non-standard variables |
| Controlled Terminology Webinar Session 1 | Controlled Terminology Slides | April 2, 2019 | 10:00am - 11:30am EST | Using Controlled Terminology New Term Requests |
| Controlled Terminology Webinar Session 2 | Controlled Terminology Slides | April 2, 2019 | 3:00pm - 4:30pm EST | Using Controlled Terminology New Term Requests |
| CDISC SME Meeting | April |
| 8, 2019 | 2:00pm - 4:00pm EST |
| CANCELLED due to lack of agenda items | |||
| CDISC SME Meeting | April 16, 2019 | 3:30pm - 5:30pm EST |
| CANCELLED due to lack of agenda items | ||||
| Custom Domains Webinar Session 1 | Custom Domains Webinar Slides | April 17, 2019 | 10:00am - 11:30am EST | Custom Domains |
| Custom Domains Webinar Session 2 | Custom Domains Webinar Slides | April 17, 2019 | 3:00pm - 4:30pm EST | Custom Domains |
| Using QRS Supplements Webinar Session 1 | Using QRS Supplements Slides | May |
| 3, 2019 | 10:00am - 11:30am EST | Using QRS Supplements |
| Using QRS Supplements Webinar Session 2 | Using QRS Supplements Slides | May |
| 3, 2019 | 3:00pm - 4:30 EST | Using QRS Supplements | ||
| CDISC SME Meeting | May 10, 2019 | 2:00pm - 4:00pm EST | Pre-planned agendas based on requests the week before |
| Validating Submission Data Webinar Session 1 | Validating Submission Data Slides | May 20th |
| , 2019 | 10:00am - 11:30am EST |
Creation of Define-XML
Explain the use of validation tools to support FDA submissions | ||
| Validating Submission Data Webinar Session 2 | Validating Submission Data Slides | May 20th |
| , 2019 | 3:00pm - 4:30pm EST |
Creation of Define-XML
| 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 |
| Overview of FDA Submission Process Webinar Session 1 |
| Overview of FDA Submission Process |
| Slides | May |
| 22, 2019 | 10:00am - 11:30am EST | FDA Submission Process |
| Overview of FDA Submission Process Webinar Session 2 |
| Overview of FDA Submission Process Slides | May 22, 2019 | 3:00pm - 4:30pm EST | FDA Submission Process |
| CDISC SME Meeting | May 24, 2019 | 2:00pm - 4:00pm EST |
| CANCELLED DUE TO LONG HOLIDAY | ||||
| CDASH/SDTM/ADaM Webinar Session 1 | CDASH/SDTM/ADaM Slides | May 28, 2019 | 10:00am - 11:30am EST | How to get from CDASH to SDTM to ADaM |
| CDASH/SDTM/ADaM Webinar Session 1 | CDASH/SDTM/ADaM Slides | May 28, 2019 | 3:00pm - 4:30pm EST | How to get from CDASH to SDTM to ADaM |
| Using TA User Guides Webinar Session 1 | Using TA User Guides Slides | May 29th |
| , 2019 |
| 10: |
| 00am - |
| 11: |
| 30am EST |
| Using TA User Guides | |||
| Using TA User Guides Webinar Session 2 | Using TA User Guides Slides | May 29th, 2019 | 3 |
| :00pm - 4: |
| 30 EST |
| Using TA User Guides |
| CDISC SME Meeting |
| Review Standard AE Form (CTSU_AE) | July 9, 2019 | 2:00pm - 4:00pm EST | Pre-planned agendas based on requests the week before |
| CDISC SME Meeting | SME Slides | August |
| 23, 2019 |
| 1:00pm - |
| 3:00pm EST |
| ||
| FA Domain vs Supplemental Qualifiers | FA Domain vs Supplemental Qualifiers | May 19, 2020 |
| 2:00pm - 4:00pm EST |
| CDASH Conformance Session 1 | January 14th, 2021 | 1:00pm - 2:00pm EST | Using CDASHIG Domains to find the right Rave Form in the GLIB ALS | |
| LPO Webinar Series: CDASH Conformance Session 2 | CDASH Conformance Session 2 | January 14th, 2021 | 1:00pm - 2:00pm EST | CDASH Conformance Rules for Naming EDC Variables |
| LPO Webinar Series: CDASH Conformance Session 3 | LPO Webinar Series: CDASH Conformance Session 3 | February 10th, 2021 | 1:00pm - 2:00pm EST | CDASH Conformance Rules for Using Controlled Terminologies |
| LPO Webinar Series: CDASH Conformance Session 4 | LPO Webinar Series: CDASH Conformance Session 4 | February 25th, 2021 | 1:00pm - 2:00pm EST | CDASH Conformance Rules for CRF Question Text and Prompt |
