Responding to Site Findings

At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees it:

Site Perspective:

Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re often the ones best positioned to analyze what went wrong.
 The site team (usually led by QA or compliance professionals) needs to:

• Conduct a root cause analysis
  
  
• Propose corrective and preventive actions (CAPAs)
  
  
• Coordinate with the Principal Investigator (PI), who should always be aware of and often sign off on the response
  
  
• Demonstrate that they are taking ownership of the issue
  
  

But here’s the challenge: responding without oversharing or accidentally implicating the sponsor/CRO can be tricky. Sites want autonomy, but also need alignment to avoid missteps.

Sponsor/CRO Perspective:

Sponsors and CROs carry the risk for the overall study. So if a site submits a response that reflects poorly on the sponsor—whether intentionally or not—that’s a problem.
 From their perspective, they want:

• Visibility into the response, especially if it relates to protocol design, training, or oversight
  
  
• The ability to review and edit before submission, to avoid legal or regulatory fallout
  
  
• Assurance that site responses don't point fingers at them unnecessarily
  Sponsors also need to assess if the issue points to a breakdown in their own oversight—and if so, they must acknowledge and fix it. But as Darshan pointed out, no sponsor wants to "sink so the site can swim." It’s about mutual accountability.

The Real Answer: "It Depends"

Whether a finding is the site's responsibility or the sponsor’s comes down to the root cause:

• Did the site fail to follow their SOPs or hire unqualified staff? That’s on the site.
  
  
• Did the sponsor fail to provide adequate training or resources? That’s on the sponsor/CRO.
  
  

Both Edye and Darshan agree: most findings land in a gray zone. That’s why collaboration, transparency, and clear communication are key.

Want more of these insights? Let us know—we’ve got more hot topics on deck. 

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