ABSTRACT
B. The Investigators, Study Coordinators, and other appropriate site personnel will review the protocol to ensure the following: 1. The study objectives are clear. 2. The study design is feasible. 3. The study will not expose subjects to undue risk. 4. The study is ethically acceptable. 5. The study is financially and logistically feasible. 6. There are a sufficient number of potential subjects available for the study. 7. There are sufficient staff to conduct the study. 8. The site has the appropriate equipment to conduct the study.
