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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.



Part 1

Data Collection - Research Data Planning (2 videos ~ 40 minutes)

Part I Handout

Part 2Fundamental Concepts - Electronic Data Capture (3 videos ~ 45 minutes)

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)
Part 3 Handout  
Part 4Research Planning - Standardizing Process (1 video ~ 14 minutes)
Part 4 Handout  
Part 5Regulatory Compliance (2 videos ~ 25 minutes)
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  
Last updated by Ness, Elizabeth (NIH/NCI) [E] on Jul 24, 2016