The regulations surrounding clinical trials can be difficult to understand and interpret, even for monitors well-versed in the parts of the Code of Federal Regulations (CFR) Title 21 that relate to clinical research. When a monitor has a tiny epiphany while working through a difficult compliance issue with a site, or an “Ah-ha!” moment, we call that a “Regulation Revelation.”
Here are a few highlights:
- Waivers from the Sponsor require IRB approval for IDE studies
A monitor knows that waivers given to the site by the Sponsor require IRB approval, according to CFR Title 21 Part 312.66 for investigational drug (IND) studies. Likewise, significant changes to the protocol of device studies require supplemental approval by the FDA. But when supplemental applications are not required for device (IDE) studies, does the IRB need to approve waivers from the Sponsor?
- IRB Termination of Research
A monitor knows that 21 CFR 56.113 describes an IRB’s authority to close a study at a site when there are concerns about patient safety violations. However, can an IRB suspend or terminate approval of research in cases other than patient safety, like delinquent documentation and data reporting?
- HIPAA: Where do those requirements actually come from?
A monitor knows that patients must be informed of the uses of their Protected Health Information (PHI), particularly as it pertains to research studies. But where in the regulations does the foundation for HIPAA exist?
- Informed consent is more than a signature
Have the following requirements for proper consent , found in 21 CFR 312.62, 812.140 and 50.27, confused you or your colleagues in the past? Learn from our “Ah-ha! Moments!”
- Other questions answered in the whitepaper cover record retention, device accountability, responsibilities of IRBs, and more!
Regulations may trip us up from time to time, but they also remind us of the essential duty to protect patients at the center of these studies. Through discussions with peers and a sharp eye, certainly those moments of clarity, or “Regulation Revelations,” are possible!
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