The FDA strongly encourages submissions in standardized structure and format 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 as well as common errors in an FDA Submission. The newly released guidances will also be explored including Standardized Study Data in Electronic Format and Study Data Technical Conformance.
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.
6. Have an understanding of the newly released guidances from the FDA concerning clinical data in a submission.
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.
Meet the Instructors
Dawn Kaminski has more than 17 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 more than 250 clinical trials.
During her tenure with Accenture, formerly Octagon Research Solutions, Ms. Kaminski has provided consultation to organizations and developed standardized libraries and templates in the adoption of CDISC standards. Dawn 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 and Diabetes sub-team. She has also played an essential role in the development and productizing of FUSE EDC.
Dawn currently serves as Director, Clinical Data Strategies where she supports business development as a Clinical Subject Matter Expert.
Dan Crawford has been in the pharmaceutical industry for 25 years in Data Management capacities at both large Pharmaceutical and CRO organizations, and managed or had oversight on more than 250 clinical trials.
Dan is the Director of Clinical Data Strategies at Accenture Accelerated R&D Services. In this role, he supports clients through training and consulting services on the implementation of data standards and their role in FDA submissions.
Dan also supports business development activities as a Clinical Subject Matter Expert.
Dan is an active member of SCDM as a GCDMP SME, course designer and webinar presenter. Dan serves as a member of the CDISC-CDASH core team and Diabetes sub-team
Participants are eligible to receive CEUs upon attendance and succesful completion of a web-based assesment.
SCDM is authorized by IACET to offer 0.2 CEUs for this program. Each part of this 2 part webinar carries 0.2 CEUs.