Faculty and staff from Duke Center for Health Informatics (DCHI), Duke Translational Medicine Institute (DTMI), and Duke Clinical Research Institute (DCRI) were active at the Annual Meeting for the Society of Clinical Data Management (SCDM), held September 10-13, 2013 at the Sheraton Chicago Hotel & Towers in Chicago, IL. The details regarding these presentations are included below.
Meredith Nahm Zozus, PhD, Associate Director for Academic Programs for DCHI, gave a presentation titled “Core Competencies: Foundations for Curricula and Job Descriptions”. Dr. Nahm also led a workshop titled “Post-Conference Workshop II: Therapeutic Area Data Standards in Development – What’s New and How to Use Them.”
Anita Walden, Senior Informaticist at the Duke Translational Medicine Institute (DTMI), chaired a session titled “Data Management Remix: Different Tools, Techniques and Terminologies for Various Types of Studies.” In the past, SCDM has focused primarily on presenting topics for those submitting data to regulatory agencies such as the Food and Drug Administration (FDA), but as the need for training increases, conference attendance is growing from individuals representing academic institutions, foundations, and other types of organizations. Anita’s session covered topics not specific to clinical trials but applicable to all types of data management. This was another in a series of sessions to introduce informatics tools and techniques to the data management
community. Topics included data mining and natural language processing, design of data entry screens in local languages, and standard terminologies.
Anita Walden and Rachel L. Richesson, PhD were invited to deliver a panel presentation at the conference. The panel, titled “Implementing Standard Terminologies in Clinical Research,” described federally available data standards (LOINC, RxNorm,
NDF-RT, and SNOMED CT) and how they can be used by study designers and data managers to improve data quality and research efficiency.
SCDM Conference Agenda details are noted below.
Data Management Remix: Different Tools, Techniques and Terminologies for Various Types of Studies
This session explores novel and some freely available tools, techniques and terminologies that empower data managers to leverage Electronic Health Record data, increase sites and patient enrollment in special populations and trials globally. During this session the data manager will be introduced to concepts that can be used in the industry, academic, non-profit or government settings.
The rapidly changing landscape of clinical research is requiring data managers to expand their knowledge beyond the familiar to utilize data from diverse sources, implement new technology and develop robust data acquisition tools that increase the value of datasets. Each of these presentations is unique but has a common informatics thread that demonstrates the use of non-traditional tools and techniques to meet the needs of a wider audience of data managers performing various types of trials and studies.
- Find out how a data manager is facilitating global participation using tools in local languages that can increase enrollment and potentially improve data quality.
- Learn more about data mining text in electronic health records using Natural Language Processing tooling which is becoming a hot topic in clinical research adding to the sources of available electronic data.
- Learn how this informaticist is increasing the value of data using national and international public data standards and software, some that are open source or freely available in various countries. Find out where you can obtain these available tools and resources.
Anita Walden, Senior Informaticist and Project Manager, Duke Translational Medicine Institute
Implementing Standard Terminologies in Clinical Research
Rachel Richesson, PhD, MS, MPH, Informaticist and Professor, Duke University School of Nursing
A Clinical Information Management Platform for Semantic Exploitation of Clinical Data
Christian Seebode, PhD, Physician MD and Computer Scientist, Diploma Informatics, CTO ORTEC Medical, Health Intelligence Platform
Implementation of a Redcap Project in Multiple Languagues
Heather Lansky, BS, Clinical Research Data Manager, Center for Clinical and Translational Science, Department of Biomedical Informatics, The Ohio State University
Project Management: Momentum
The purpose of this presentation is to cognitively and affectively impact the audience by addressing the importance of project management in the CDM discipline. Through the speaker’s real life stories, this session will straightforwardly discuss how good project management creates positive momentum in the discipline of CDM. In today’s contemporary CDM work environment the make or break principle is coming out successful and on top may hinge on how well one gains momentum through the proper understanding and execution of project management skills. These skills are often over looked or assumed to be understood; however improperly applying project management skills can prevent risk to successfully reaching ones goal. It is the speakers hope that the audience will be encourages and challenged to see how project management impacts their professional lives.
Stephen Starr, BS Business Administration with Concentration in Management Sciences, Lead Clinical Data Manager, Duke Clinical Research Institute
Becoming a Top Notch Data Manager: Resources, Tools and Qualities to Cultivate
Ms. Chandra Wooten, CCDM, Senior Clinical Data Manager, Statistics & Data Corporation
Project Management and Clinical Endpoint Studies
Suellen Bertram, BS Biology MT (ASCP), Clinical Data Associate, Eli Lilly & Company
Positive Project Data Management Conduct Impacts a Project’s Success
Christina Bordick, B.S., Lead Clinical Data Manager, RPS (Research Pharmaceutical Services Inc)
Training the Next Generation of Clinical Data Managers: The Industry/Academia Interface
Only recently have academic institutions attempted to emulate industry-based models with respect to Good Clinical Data Management Practices and modify them for use in academic settings. With few programs at either the undergraduate or graduate levels, education of clinical data managers has largely been conducted at the discretion of the employer. The purpose of this session will be to offer models of instruction and evaluation that can be used to facilitate and enhance the training of clinical data managers across a range of employment settings.
Richard F. Ittenbach, PHD, Research Professor of Pediatrics, CCHMC
Developing and Evaluating a Comprehensive Educational Program for Clinical Data Managers in an Academic Medical Center
Richard F. Ittenbach, PHD, Research Professor of Pediatrics, CCHMC
Training Data Managers in Industry
Kit Howard, MS, CCDM, Senior Director, Education, CDISC
Core Competencies: Foundations for Curricula and Job Descriptions
Meredith Nahm, PhD, CCDM, Assoc. Director Clinical Research Informatics, Duke Translational Medicine Institute, Duke Center for Health Informatics
Post-Conference Workshop II: Therapeutic Area Data Standards in Development – What’s New and How to Use Them
Meredith Nahm, PhD, Assoc. Director Clinical Research Informatics, Duke Translational Medicine Institute, Duke Center for Health Informatics