2 part webinar
The FDA strongly encourages submissions in standard form for regulatory applications. The Clinical Data Interchange Standards Consortium (CDISC) is a standards development organization which has collaborated with the FDA. The first part of this two part webinar will examine the basic components of the CDISC standard that have been accepted by the FDA since 2004. These basic components will include the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM). The relationship between SDTM and Clinical Data Acquisition Standards Harmonization (CDASH) will also be examined. The second part of this webinar will discuss the experience of the FDA with submissions using the CDISC standards. Topics in part two will include controlled terminology, coding, variables, common errors and areas where the FDA and CDISC are not in agreement.
What You’ll Learn
Attendees will be able to:
1. Describe the basic components of the SDTM.
2. Explain the relationship between the SDTM and CDASH.
3. Describe the basic components of the ADaM.
4. Explain the relationship between the SDTM and the ADaM.
5. Describe the common challenges with CDISC data standards submissions to the FDA.
Participants will gain a basic understanding of the CDISC SDTM and ADaM. In addition, participants will learn common issues from the perspective of the FDA with respect to CDISC data standards submissions.
Who Should Attend
Advanced, experienced CDMs, CRAs, biostatisticians, regulatory and clinical programmers.
Dawn Kaminski has over 15 years of experience in the pharmaceutical industry. She has worked within every level of clinical data management, from Data Coordinator to Director where she participated in or had oversight for over 250 clinical trials. During her tenure at Octagon, Ms. Kaminski has lent her expertise to the development of products such as Data JumpStart, a combination of expert consulting with standardized libraries and templates to assist organizations in the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter. Dawn serves as a member of the CDISC-CDASH core team. She has also played an essential role in the development of Octagon's EDC Software platform FUSE™. Dawn currently serves as Product Manager for FUSE where she is responsible for all releases and enhancements to the EDC system as well as future product planning.
Dan Crawford is currently the Director of Clinical Data Strategies at Octagon Research Solutions. Dan has been in the pharmaceutical industry for 25 years in both large Pharma and CROs. Dan spent fifteen years in Data Management where he managed or had oversight on more than 250 clinical trials as the Director of Data Management. Currently at Octagon, Dan provides training and consulting on the implementation of data standards and their role in submissions to the FDA. He supports the business development efforts as a Subject Matter Expert on areas such as SDTM, Data Management, EDC, Programming, Statistics and overall process and program management of clinical trials. He is integral in creating FUSE™, Octagon's EDC solution. Dan is also a core team member of CDASH and actively participates in authoring and presenting educational materials for the Society of Clinical Data Management.
Participants are eligible to receive CEUs upon attendance and succesful completion of a web-based assesment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program. Each part of this 2 part webinar carries 0.2 CEUs.
Registration for this webinar is now closed.