A reminder to PIs: The Buck Stops Here
Principal investigators (PIs) are ultimately responsible for everything that occurs on research at their sites. Few things irk monitors and auditors (including those from agencies such as the Food and Drug Administration) than hearing, “Well, that’s not my fault. That’s the study coordinator’s responsibility,” from a PI, in response to a finding.
The Duke Clinical Research Institute recently made available online a handy recap of PI responsibilities in clinical research. The full article can be accessed here. A summary is:
- The PI must know the protocol inside and out, and ensure that study tasks are appropriately delegated to qualified staff.
- The PI ultimately oversees the informed consent process, even if other staff conduct the actual process.
- The PI must ensure that source documents are available and that information about trial endpoints and adverse events are collected in a timely fashion.
- The PI is responsible for ensuring that all required IRB reporting is completed within the required timeframes.
If you’re a PI, please take a look at this full article at the link above. It contains good information about everything expected of PIs. While some of it may not be applicable to people who don’t work in clinical research, many of these requirements pertain to other types of investigators as well. And if you’re a study team member, the article is a good refresher on what you’ll need to make sure your PI stays on top of.