The NIH Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, “Assessing Fitness-for-Use of Real World Data Sources,” describes several approaches for determining whether real-world data are fit for their intended purpose in pragmatic clinical trials.

“Real-world data” are collected for clinical care, insurance claims, administrative purposes, registries, or are generated directly by the patient. Because these data are collected for a purpose other than a specific research project, an investigator must understand the characteristics and limitations of the data to determine whether they can be used in a pragmatic trial.

The new chapter includes the following sections:

• Introduction
• Defining Fitness for Use
• Data Quality Measures
• Data Provenance
• Operationalizing Fitness-for-Use Assessments

The new chapter updates a previous resource based on work by experts in the NIH Collaboratory’s Electronic Health Records Core Working Group.