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IRB Management

Automating the IRB Renewal Process

Don't clinical studies have enough headaches without worrying about compliance issues? One important facet of compliance is ensuring that IRB/EC annual renewal approvals take place in a timely fashion. Sites need well-documented and auditable reminders to conduct the renewal process. How are you currently doing this? Most people use a manually updated spreadsheet, but long for something better.

The MedNet ENLIGHTEN^TM IRB Management solution has been built to simplify and automate the entire IRB renewal process. It substantially decreases the manual work effort required while simultaneously raising the level of site compliance to extremely high standards.

Managing IRB renewals suddenly becomes far easier. Using the IRB approval date captured within Site Documents in MedNet's ENLIGHTEN eClinical Solution, the IRB Management functionality automatically communicates upcoming renewal dates to sites via email and/or fax. Sites continue to receive reminders on a daily basis until they either acknowledge message receipt or submit their renewal approval. If a site does not forward IRB approval by the required date, the system can be configured to automatically preclude further enrollments while still permitting completion of existing patient follow-ups and tasks. Automatically. With full audit trails. No headaches.

Key Features

• High degree of sponsor/CRO configuration capability:
  • Message recipient(s) (PI, RC, others)
    
  • Communication media (email, fax, both)
    
  • Message text
    
  • Message effects (bold, italics, etc.)
    
  • Insertion of graphics (logos, tables, etc.)
    
  • Automatic, site-specific message personalization via database variable insertion
    
  • 1-4 automatic message triggers (based on days until renewal).
  • Non-compliant site enrollment restrictions and messaging (on/off)
• Full audit trails include date/time stamped messages and site responses
• User configurable reports detailing renewal dates, days until renewal, notifications sent, etc.

Key Benefits

• Promotes excellent compliance in a highly automated fashion
  
• Significantly reduces burden of work and regulatory risks
  
• Increases site satisfaction and motivation through clear and meaningful communications