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.