Clinical Research Operations

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, the development of case report forms, data privacy and security, and quality control. The required content of this module is from the “Introduction to the Principles and Practice of Clinical Research (IPPCR): Data Management Overview,” a four-part video series presented by Christine Gordon, Clinical Data Management Project Manager, CCR, NCI, NIH, in September 2023. There is one recommended video.  

Once you have completed the four required videos, please complete 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.
• Discuss the data handling processes.
• Describe what a case report form is and how it is developed.
• Discuss quality management activities related to CDM.