Key Clauses in PI Contracts to Review

Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can expose sites to financial, legal, and operational danger if not carefully reviewed.

Key Risks to Watch Out For:

• Compensation Structures: Incentives tied to patient enrollment can raise anti-kickback and fraud concerns. Payments should reflect fair market value for time and expertise, not results.
  
  
• Data Ownership: If not explicit, investigators may claim ownership of trial data, patient lists, or publication rights. Agreements should clarify that the site owns study data and records.
  
  
• Non-Competes & Moonlighting: Overly broad restrictions may be unenforceable, while too weak protections allow PIs to compete directly. Clauses must be narrow, specific, and tied to legitimate business interests.
  
  
• Exit Strategies: Standard agreements often miss compliance safeguards. Sites need termination rights for events like loss of medical license, federal program exclusion, FDA disqualification, or protocol non-compliance.
  
  

Takeaway:
 Physician agreements are not just HR paperwork—they determine a site’s survival. Poorly drafted contracts can act like ticking time bombs. Sites should ensure agreements protect data, comply with regulations, and safeguard operations.

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