SCDM Education Portal

Data Standards in Clinical Research

Course runs September 11 - October 15, 2017
 
Overview
 
This five week instructor facilitated online course is an introduction to the CDISC, HL7 and associated data standards including:
  • BRIDG domain model
  • Clinicaltrials.gov data elements
  • Therapeutic area-specific Data Elements including: 

     

    • National Cancer Institute’s CaDSR Common Data Elements
    • CDASH data elements
    • CDISC SDTM
    • CDISC LAB
    • CDISC ODM
    • Individual Case Safety Report (ICSR)
    • Annotated ECG waveform standard
  • A general overview of data models such as:
    • The National Patient-Centered Clinical Research Network (PCORnet)
    • Observational Medical Outcomes Partnership (OMOP) 
Instruction on specific standards is bookended by an overview of standards development and practical methods for standards adoption and implementation. The course provides awareness of the standards relevant to Clinical Research. Topics covered include the purpose, scope (information content), format (information structure) and level of authority of each covered standard. Opportunities for additional training, documentation for each standard, and related resources are emphasized.
A combination of online discussions, activities and assignments will support the objectives of this course.
 
What You’ll Learn
 
Participants completing the training should be able to accomplish the following objectives:
  • List the content and structure of a standard
  • Compare and contrast the various standards
  • Describe how to use the standard in a clinical trial
  • Indicate where to find the documented standard
  • List the clinical research standards
The course addresses how data standards impact practice in the following CCDM certification core competencies: protocol review, CRF design, clinical database design, coding, lab data processing, and SAE reporting.
 
Who should attend
 
This course is intended for all clinical data managers who must be aware of standards and how to use them in clinical trials. Experience level: intermediate.
 
Meet the Instructor
 
Anita Walden has a background in Clinical Research Data Management in Academic, Pharmaceutical and Contract Research Organizations. She has managed national and international clinical trial databases for over 25 studies along with serving as a project facilitator for developing international therapeutic data standards. Currently, she is facilitating and managing informatics projects for Duke Translational Medicine Institute and a data management consultant for other organizations. She is serving a Co Chair and Publishing Facilitator of the HL7 Clinical Interoperability Council Working Group and Trainer for Society of Clinical Data Management (SCDM) University Training program. 
 
Course Tuition
 
$1020 members/$1140 nonmember
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the course start date. If cancellation occurs by the end of week one of the course, students will be allowed to apply 50% of the course fee to the next offering of the same course. No refunds will be offered after that time. 
 
Earn CEUs
 
Participants are eligible to receive CEUs upon successful completion of the course.
SCDM is authorized by IACET to offer 2.0 CEUs for this program. 
CDISC fully supports this professional development opportunity for clinical data managers and those involved in related activities. To receive technical training on the CDISC standards, SCDM recommends authorized CDISC training. Visit their website http://www.cdisc.org/education-and-events for a full description of opportunities.