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Policies Institutional Policies and associated Standard Operating Procedures that govern research and at Wake Forest Baptist Health

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    Key Institutional Policies 

    • Conflict of Interest

    • Conflict of Commitment

      • No Retaliation policy
      • Biosafety Levels for Human Research Involving Cell Lines
      • Use of Controlled Substances in Research

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    Regulatory Policies

    • Quality Conduct of Clinical Research (Policy)
      • Compliance in the Conduct of Human Research
      • Retention and Destruction of Human Subjects Research Data and Records (SOP)
      • Internal Post-Approval Monitoring of Human Subjects Research (SOP)
      • Sponsor Monitoring of Human Subjects Research (SOP)
      • External Audits of Human Subjects Research (SOP)
      • Registration of Clinical Trials in clinicaltrials.gov (SOP)
      • Investigational/FDA Conditionally Approved Medical Devices (SOP)
      • Quality Conduct of Research Policy (SOP)
      • Training of Human Research Principal Investigators
      • Training of Human Research Coordinators
      • Export Controls (SOP)
    • Research Integrity Policy
    • Institutional Oversight of Animal Research and Teaching Policy
    • Institutional Oversight of Human Research Policy 
    • Data Ownership Policy
    • Authorship Policy

    Related External Resources

    NIH Bioethics Resources on the Web

    Incidental Findings Guidance

    Clinical Research Policies

    • Billing Compliance for Human Subjects Research (Policy)
      • Coverage Analysis for Human Subjects Research (SOP)
      • Revenue Cycle and Order Entry for Human Subjects Research (SOP)
      • Review, Segregation and Processing of Claims for Human Subjects Research (SOP)

    • Documentation in the Medical Record for Human Subjects Research (Policy)
      • Documentation in the Medical Record for Human Subjects Research (SOP)
    • Intake, Review and Approval of Industry-Sponsored Human Subjects Research (Policy)
      • System Access for Industry-Sponsored Human Subjects Research (SOP)
      • Research Intake for Industry-Sponsored Human Subjects Research (SOP)
      • Study Feasibility for Industry-Sponsored Human Subjects Research (SOP)
      • Study Start-Up for Industry-Sponsored Human Subjects Research (SOP) 
      • Budget Development and Negotiation for Industry-Sponsored Human Subjects Research (SOP)
      • Site Initiation Visits for Industry-Sponsored Human Subjects Research (SOP)

    Interdisciplinary Policies

    • Service Center Policy

    Sponsored Programs Policies

    • Study-Project Closeout Standard Operating Procedure
    • Timeline for Establishing New Chartfields for Newly Sponsored Awards (Update coming soon.) 
    • Residual Funds Policy
    • Wake Forest School of Medicine Proposal Submission Deadline Policy
    • Effort Certification Policy
    • Establishing Clinical Trials Accounts
    • Financial Management of Activities Related to Research
    • Graduate Student Tuition on Sponsored Projects
    • Cost Sharing Policy 
      • Cost Sharing (SOP)
      • Continuation Account Request for Sponsored Programs
    • Cost Transfer Policy
      • Cost transfer (SOP)

    Related External Resources

    National Science Foundation (NSF) Grants Policy Manual

    Uniform Guidance

    Amended NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

    Connect with CTSI

    CTSI Administration
    486 North Patterson
    Winston-Salem, NC 27101
    CTSI@wakehealth.edu
    Phone: 336-716-1195 | Fax: 336-716-1358

    Office of Sponsored Programs (OSP)
    1st Floor, Meads Hall
    1 Medical Center Boulevard
    Winston-Salem, North Carolina, 27106
    Phone: 336-716-2382 | Fax: 336-716-4480 

    Institutional Review Board (IRB)
    8th Floor, Hanes Building
    1 Medical Center Boulevard
    Winston-Salem, North Carolina, 27106
    Phone: 336-716-4542 | Fax: 336-716-9902 

    Institutional Animal Care and
    Use Committee (IACUC)
    2nd Floor, Lockland Avenue
    Winston-Salem, North Carolina, 27106
    Phone: 336-716-3540 

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    Disclaimer: All research and clinical material published by Wake Forest School of Medicine on its site is for informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider. Wake Forest School of Medicine will not be liable for any direct, indirect, consequential, special, exemplary, or other damages arising therefrom.

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