Sharing Data on caGrid at the Mayo Clinic Cancer Center

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Sharing Data on caGrid at the Mayo Clinic Cancer
Center

• Issues and Challenges

Sharon Elcombe, Mayo Clinic Cancer Center May 15,
2007
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Background

• Mayo Clinic Cancer Center has been an active
  participant in multiple workspaces, this
  presentation will focus on the formal adoption of
  the caBIG Adverse Event Reporting System caAERS
  in the CTMS Workspace
• Part of the adoption process includes sharing
  adverse event data on caGrid
• MCCC has no previous experience in this arena
  regarding clinical trials data uncharted
  territory

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Background (2)

• Anticipate
• policy,
• privacy,
• technology issues
• Related to
• Cancer Center
• Mayo Clinic

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Policy Issues

• Cancer Center
• What data can be shared (adverse event data
  inherently sensitive)
• When can it be shared (during the active phase of
  the trial?, only after publication?, etc.)
• With whom authorized roles (sponsors,
  investigators, public, etc.)
• Approval candidates Biostatistics, Cancer Center
  Operations and Management Committee, DSMB

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Policy Issues (2)

• Institution
• What data can be shared
• When can it be shared
• With whom (sponsors, investigators, public)
• Approval candidates Institutional Research
  Committee

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Privacy Issues

• Institution
• Regulatory Requirements (HIPAA, institutional
  privacy policy, etc.) Compliance Office
• May potentially be referred to the IRB

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Technology Issues

• Institution
• Appropriate hardware
• Appropriate architecture
• Appropriate security model (authentication,
  authorization)
• Safeguard data inside and outside of the firewall
  and data transmissions
• Data Security Committee