Research Protocol

    1. Statement of objectives and purpose of the study.
    2. Name, address, and statement of qualification (e.g., CV) of each Investigator and Sub-investigator.
    3. Name and address of each research facility to be used.
    4. Name and address of each IRB/IACUC/IBC to be used.
    5. Subject selection criteria, exclusion criteria and estimated number to be studied, for IRB and IACUC applications.
    6. Summary of study design, including control(s) and steps to reduce bias risks.
    7. The materials, compounds, etc. to be used and why, when applicable.
    8. For drug studies, methods to determine dosing, expected maximum dosage, and duration of exposure to drug.
    9. Study procedures.
    10. Observations and measurements to be made during the study.
    11. Clinical procedures, laboratory tests and other measures to be taken to monitor the test article’s effects and minimize risks to subjects for IRB studies.
    12. Summary of data analysis and statistical methods to be used.