Going Beyond the Implementation Guide: Why and How to Use Global Data Standards When You Don’t Have To
December 4, 2019
In this webinar we will explore the value of using global, open data standards for clinical research when the data are not intended for a regulatory submission.
The presenter will provide practical tips and examples for applying global data standards to use cases beyond the typical regulatory submission dataset, including use cases for observational studies, public health databases, and disease data repositories.
References to other useful, global standards will be made throughout the presentation to build awareness of the scope of clinical and research data standards, and how they can be used to support each other.
WHAT YOU'LL LEARN
- Key aspects of the Study Data Tabulation Model Implementation Guide (SDTMIG) that are primarily for Regulatory Review (which can or should be ignored for other use cases)
- General awareness of the world of clinical data standards
- How other standards (e.g., FHIR, LOINC and CDASH) support clinical data management processes
WHO SHOULD ATTEND
- Academic Research and people working with Public Health data
- Clinical Data Managers
- Clinical Database Programmers
- Clinical Database Administrators
- Other Clinical Research Professionals interested in aggregating or sharing data
WHAT ARE THE BENEFITSParticipants will learn how to apply global data standards to use cases that go beyond the requirements in published Implementation Guides, so even if someone is already well-versed in using the SDTMIG for standardized data submissions to US FDA or Japan PMDA, they will learn how and why to apply different rules for other use cases.
- Build awareness of global data standards that support all kinds of clinical research (academic, public health, observational, retrospective, pragmatic)
- Apply data standards to their research process for higher efficiency and quality
- Explore examples from three different use cases for applying global data standards to academic and other non-registration clinical research
MEET THE PRESENTERShannon Labout, CEO & Principal Consultant of Data Science Solutions LLC
Shannon has 25 years’ global experience implementing and managing healthcare and research technologies, providing strategic and tactical organizational leadership, and developing, implementing and teaching best practices in clinical data management and data standards for industry, regulators, public health organizations and academia in multiple therapeutic areas of drug and medical device research.
Shannon is an enthusiastic volunteer in several industry organizations. She has served on the Board of Trustees for the Society of Clinical Data Management (SCDM) since 2014 and was the 2018 SCDM Board Chair; has been a CDISC CDASH volunteer since 2006; and has been actively involved in the PhUSE Data Transparency and Optimizing the Use of Data Standards Working Groups for several years. Most recently she led the PhUSE GDPR Project Data Collection and PII sub-team to collaborate on a PhUSE White Paper with recommendations for applying GDPR principles to clinical research data operations.
EARN CEUsParticipants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
|Group (max. 10 ppl.)||$960||$1,140|
Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.
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