Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

Journal Article (Journal Article;Pragmatic Clinical Trial)

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.

Full Text

Duke Authors

Cited Authors

  • Roberts, MK; Fisher, DM; Parker, LE; Darnell, D; Sugarman, J; Carrithers, J; Weinfurt, K; Jurkovich, G; Zatzick, D

Published Date

  • September 2020

Published In

  • Ethics Hum Res

Volume / Issue

  • 42 / 5

Start / End Page

  • 29 - 37

PubMed ID

  • 32937035

Electronic International Standard Serial Number (EISSN)

  • 2578-2363

Digital Object Identifier (DOI)

  • 10.1002/eahr.500066


  • eng

Conference Location

  • United States