Abstract
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.
Original language | English (US) |
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Pages (from-to) | 29-37 |
Number of pages | 9 |
Journal | Ethics and Human Research |
Volume | 42 |
Issue number | 5 |
DOIs | |
State | Published - Sep 1 2020 |
Keywords
- Good Clinical Practice (GCP)
- Health Insurance Portability and Accountability Act (HIPAA)
- informed consent documentation
- institutional review board (IRB)
- noncompliance
- pragmatic clinical trials
ASJC Scopus subject areas
- Health(social science)