Sponsor-Investigator Responsibilities
    • Study design and research protocol development
    • Study implementation and oversight
      • Participant inclusion
      • Obtaining proper informed consent
      • Compliance with protocol
    • Maintenance of study documents
    • Ensure data integrity and protect the privacy, rights, safety, and welfare of study subjects
    • Regulatory Submissions and Compliance
      • IRB/EC approvals
      • Regulatory Agency approval (e.g. U.S.FDA IDE) if required
      • Protocol amendment submissions
      • Continuing reviews
      • Final study reports
      • Safety reporting
    • Contract with third-party vendors
    • Database development and data analysis
    • Provide regular (at a minimum quarterly) updates to Apyx Medical on the study progress
    • Publications
Apyx Medical Responsibilities
    • Evaluate the proposed study for funding based on scientific merit, business alignment, and regulatory compliance
    • Provide and distribute updated, approved product information
    • Provide research grant funding
    • Monitor trial progress in accordance with agreed upon milestones and protocols
    • Review the protocol and any protocol amendments
    • Review study manuscripts prior to publication
Part A: Grant Proposal


    • Study overview
      • Rationale
      • Design
      • Objectives and Hypothesis
      • Study Duration
    • Principal Investigator CV
    • Proposed Budget
Part B: Full Application


    • Complete Protocol
    • Detailed and Itemized Budget with justification
    • Current medical license for Principal Investigator
    • Co-Investigator CVs (if applicable)
    • Enrollment projections
    • Site W-9


    • Case Report Forms
    • IDE/IRB/EC Approval, if approval has already been received.  If approval has not been obtained, the approval may be provided after the application is submitted, once obtained 
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