When the U.S. Food and Drug Administration (FDA) comes calling, “it’s always the site’s fault,” said an only half-joking Ana Marquez, CEO of Marquez Clinical Site Partners, LLC, as she was conducting a full-day workshop at the ACRP 2017 Meeting & Expo on April 28 in Seattle, Wash.
“Sponsors will point their fingers at you, contract research organizations (CROs) will point their fingers at you,” she warned.
Armed with that information, it is vitally important for site leaders to take concrete steps to protect themselves and their staff throughout the clinical trial process.
For example, don’t accept a monitoring letter dated weeks before you actually received it. All too often, Marquez said, that letter must go through a slow internal review process at the other end before it is sent to your site. That means you might get a letter in your hand dated a month earlier. When the FDA comes to inspect, they’ll want to know why you took so long to address a problem raised in the letter, Marquez said, thinking you had known about the alleged shortcoming far longer.
Her shop won’t accept such a letter if it is dated three or more days before actual receipt. Push back and demand a letter that more accurately reflects when you were notified of something, she suggested. Sometimes the monitoring letter author will resist and you’ll have to go to a supervisor, Marquez added.
Another tip: Be wary of a sponsor waiver concerning any aspect of a study. In many cases, the FDA will still issue a Form 483 (observations of concern from an inspection) to a site even with that so-called protection. With that in mind, Marquez recently rejected a subject accepted by the sponsor because it didn’t feel right.
Another useful tool when it comes to maintaining data integrity and a defensible paper trail is the ALCOA model, Marquez said. It stands for:
- Attributable: Can you show who created the data and when?
- Legible: Is it easy to read?
- Contemporaneous: Is it timely?
- Original: Have you been able to maintain the “source” of the data?
- Accurate: Does it reflect what actually happened?
You’ve got to stick to your guns to protect your site, Marquez emphasized, because no one else is going to do it for you.
Author: Michael Causey