Overview of Emerging and Established Standards

1 part webinar
60-minute presentation followed by 30-minute Q&A

The intent of this webinar is to provide attendees with a high level overview of current and emerging data standards impacting the clinical research industry. This webinar will orient attendees to the Good Clinical Data Management Practices chapter that has been produced by SCDM addressing standards impacting the data management realm of the clinical research industry. An understanding of CDISC standards, including CDASH, SDTM, ODM, LAB and AdAM and HL7 standards will be among the standards addressed in this webinar. Additionally, the convergence of electronic health records and clinical research will be discussed with an emphasis on standards initiatives currently underway.

This is the precursor webinar for the detailed 3 part webinar series, July 9, 23, & 30, entitled "From Protocol to Collection to Submission – Putting CDISC Standards to Work for You!"

Presenters

Jonathan Andrus, CCDM, Vice President, Data and Study Operations, manages data and study operations for BioClinica, Inc. In this role he is responsible for overseeing the design, development, implementation and management of all clinical studies. This includes forms design, standards and standards management, edit check programming, clinical data review and medical coding.

Prior to joining PDS, Mr. Andrus managed clinical system validations and Part 11 & HIPAA assessments, and conducted computer system audits with Taratec Development Corporation. He also served in a number of different data management and business process management roles at Premier Research, a contract research organization located in Philadelphia, PA.

Mr. Andrus has a Masters of Science in Quality Assurance and Regulatory Affairs from Temple University ’s Graduate School of Pharmacy, a Bachelor of Arts from Temple University ’s College of Arts and Sciences, and he is a certified quality auditor (CQA) and certified clinical data manager (CCDM). His professional affiliations include the Drug Information Association (DIA), the Society for Clinical Data Management (SCDM) (where he serves on its board of trustees and is currently the immediate past chair), the American Society for Quality (ASQ) and the EHR Value Case Working Group. Mr. Andrus is a frequent speaker on topics related to electronic data capture, quality assurance and regulatory topics.

Jennifer Price is the Senior Director of Clinical Solutions at Phoenix Data Systems. In this role, Jennifer assists PDS clients with developing and executing strategies to successfully implement eClinical technologies and standards within their organizations. She has 20 years of Pharmaceutical Industry experience and had focused exclusively on EDC implementations for 5 years. Jennifer is a Certified Clinical Data Manager (CCDM) and a certified SAS Programmer.

Her professional affiliations include the Clinical Data Acquisition Standards Harmonization Initiative (CDASH) Initiative Working Group, Drug Information Association, PharmaSUG (executive committee emeritus), and the Society for Clinical Data Management (SCDM).

Prior to joining PDS, Jennifer was a Senior Manager of the Clinical Systems Department responsible for implementing and validating all clinical systems at Cephalon Inc.

Target Audience

Executives, C Level Management, Senior Management within Data Management and Clinical Research

Continuing Education Credit Opportunity

Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.
SCDM is authorized by IACET to offer .2 CEUs for this program.