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Webinars

THU, 24 AUG 2017 12:30PM CDT
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Members Only Mini-Trainings are a benefit of CDISC membership. All employees of CDISC members may participate in Members Only Mini-Trainings. If your organization is not a CDISC Member, join us to support the development and adoption of global standards and reap the many benefits of CDISC membership. Should you have membership-related questions, please contact membership@cdisc.org.

Title
Governance for Data Capture Standards

Description
Good governance is critical for ensuring consistent and “fit-for-use” data. Data governance standards should begin with the data capture environment and designing well-defined elements. While some aspects will be customized to a company, many are general and apply across organizations. Join CDASH experts to explore considerations and best practices in data capture standards governance.

Date and Time
THU, 24 AUG 2017 
12:30 PM - 2:00 PM CDT

Webinar Language
English

Panelists

  • Gary Walker, Associate Director, Quintiles 
  • Michael Ward, Data Standards Consultant, Eli Lilly 
  • Melissa Binz, Business Process Owner - Study Data Management, Pfizer 
  • Judy Tran, Manager, Medidata Solutions 
  • Trisha D. Simpson, Director, Global Biometry Standards, UCB Pharma

Click here to ensure your machine has the necessary requirements to run CDISC webinars (run by Citrix).

Please register for this members only webinar using your organizational e-mail address. If you aren't sure whether your organization is a CDISC Member, please review the member list here and confirm before you register. 

 

 


THU, 28 SEP 2017 10:00 AM CDT
REGISTER NOW

Members Only Mini-Trainings are a benefit of CDISC membership. All employees of CDISC members may participate in Members Only Mini-Trainings. If your organization is not a CDISC Member, join us to support the development and adoption of global standards and reap the many benefits of CDISC membership. Should you have membership-related questions, please contact membership@cdisc.org.

Title

CDISC Members Only Mini-Training Series - Define-XML v2.0 Completion Guidelines and Style Sheet Recommendations

Description

Define-XML transmits metadata for SDTM, SEND and ADaM datasets; it is the metadata file sent with every study in each submission, which tells the regulatory authorities what datasets, variables, controlled terms, and other specified metadata were used.

Define-XML is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.   

Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page

Date and Time
THU, 28 SEP 2017 
10:00 AM - 11:30 AM CDT

Webinar Language
English

Panelists:

  • Marcelina Hungria, Data Submission Consulting Services, Dlcore Group, LLC 
  • Dmitry Kolosov, Principal Statistical Programmer, PAREXEL 
  • Lex Jansen, Principal Software Developer, SAS Institute Inc. 
  • Prafulla Girase, Principal Analyst, Biogen
  • Sally Cassells, Owner, Next Step Clinical Systems LLC 

Click here to ensure your machine has the necessary requirements to run CDISC webinars (run by Citrix).

Please register for this members only webinar using your organizational e-mail address. If you aren't sure whether your organization is a CDISC Member, please review the member list here and confirm before you register.