SCDM Education Portal

The DMP (Data Management Plan) and its significance within CDM

 


 

Overview

The DMP is the core documentation tool within CDM for a given study. It can and should be used as main reference during audits. However, even though the DMP is broadly used in most CDM groups, the actual content, level of detail, or required oversight sometimes remains unclear even for industry veterans.
During this webinar, the Instructor will
(a) present the advantages of using a DMP template,
(b) show the value of the DMP in an audit situation,
(c) suggest content for standard DMPs, and
(d) show the value of proper oversight and maintenance of DMPs beyond their typical usage.

 

Learning Objectives

  • Understand the significance of the DMP for CDM in a clinical study
  • Understand the (minimal) content required for a DMP
  • Use a DMP to his/her advantage in an audit situation
  • How to use a DMP in a cross-functional setting

Who Should Attend:

Beginners will learn the basic building blocks of a DMP and its importance within CDM.

Intermediate/Advanced attendees will learn new ways of how to use a DMP within a CDM group, beyond its traditional role in a given study

 

Meet the Instructor

 

Michael Goedde, VP Global Data Operations, PAREXEL Intl.

 

Michael Goedde is a Certified Clinical Data Manager with more than 24 years of experience in the pharmaceutical and biotechnology industry. 

He started his career in 1990 at Hoechst, a predecessor company of Sanofi-Aventis, in Frankfurt (Germany). After supporting numerous submissions and leading programs through all stages of clinical development, Michael then chose to join the Aventis Headquarters in Bridgewater, New Jersey (US) in 2001 as a Global Project Data Manager and Global Therapeutic Area Lead for Oncology and Neurology. After leaving Aventis in 2005 he joined Kos Pharmaceuticals in Florida for 2 years before accepting the position of Senior Director of Clinical Data Management at Human Genome Sciences (HGS) in Rockville, Maryland. After the GSK takeover of HGS in 2012, he joined MedImmune(Astra Zeneca) as Head of CDM, where he re-built the CDM department. In 2014 he decided to join PAREXEL International as VP, Global Data Operations. Michael holds a degree in Computer Sciences and is a recognized member of the Society for Clinical Data Management (SCDM). He has presented and chaired sessions on numerous occasions at conferences including an invitation from the FDA in 2010 to present on “Industry Best CDM Practices” at the Center’s Bioresearch Monitoring course.

 

Earn CEUs

Participants are eligible to receive CEUs upon attendance and
successful completion of a web-based assessment within 30 days after the
webinar. 


SCDM is authorized by IACET to offer 0.2 CEUs for this program.