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Clinical Data Management

Clinical data management (CDM) consists of various activities involving the handling of data or information that is outlined in the protocol to be collected/analyzed. CDM is a multidisciplinary activity. This module will provide an overview of clinical data management and introduce the CCR’s clinical research database. The content of this module is the Data Management in Clinical Research course developed by Vanderbilt University. The course teaches important concepts related to data planning, standards, collection, storage and dissemination. The instructors offer information and best-practice guidance for many types of research studies including investigator-initiated, sponsored studies, and multi-site studies. The National Cancer Institute Center for Cancer Research received permission to use these videos for orientation. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.

Module Objectives

At the conclusion of this module, learners will be able to:

  • Discuss what constitutes data management activities in clinical research.
  • Describe regulations and guidelines related to  data management practices.
  • Describe what a case report form is and how it is developed.
  • Discuss the data capture processes.
  • Discuss quality management activities related to CDM.

 

Required   

Part 1

Data Collection - Research Data Planning (2 videos ~ 40 minutes)
http://vimeopro.com/redcap/bmi391-research-data-planning

Part I Handout

 ResourcesEvaluation
Part 2Fundamental Concepts - Electronic Data Capture (3 videos ~ 45 minutes)
http://vimeopro.com/redcap/bmi-391-edc-fundamentals

NOTE: The order in the link for the 3 videos is reversed. Please start with the video on the right and work towards the 3rd video on the right. 
Part 2 Handout  
Part 3Real World Study Planning - Morphine/Marinol Example (5 videos ~ 45 minutes)
http://vimeopro.com/redcap/bmi-391-putting-it-all-together
Part 3 Handout  
Part 4Research Planning - Standardizing Process (1 video ~ 14 minutes)
http://vimeopro.com/redcap/bmi-391-standardizing-process
Part 4 Handout  
Part 5Regulatory Compliance (2 videos ~ 25 minutes)
http://vimeopro.com/redcap/bmi-391-regulatory-compliance
Part 5 Handout  
Part 6 Using Data Standards (video #1 ~ 15 minutes; video #2 ~ 15 minutes)Video #1 Handout Video #2 Handout  
Part 7Data Quality Monitoring (video #1 ~ 11 minutes; video #2 ~15 minutes)  Video #1 Handout Video #2 Handout  
Recommended   
 Optional
Last updated by Ness, Elizabeth (NIH/NCI) [E] on Jul 24, 2016