Polaris

CompanyReviewer’s ChecklistProtocol Number: Investigator/Site #:Protocol Date orVersionNumber:Reviewer:Sponsor:Date:Regulatory Review Requirement1. The proposed research design is scientifically sound and will not unnecessarily expose subjects to risk.Yes No (a) Is the hypothesis clearly stated?Yes No (b) Is the study design appropriate to prove the hypothesis?Yes No (c) Will the research contribute to generalizable knowledge and is it worth exposingsubjects to risk?Yes No (d) Is the scientific rationale for the study (history and background) clear?Yes No (e) Are the treatment arms clear (active, placebo, crossover)?Yes No (f) If a placebo arm is used, is this appropriate?Yes No (g) Are visits and procedures clearly described?Yes No (h) Are experimental procedures differentiated from standard treatment?2. Risks to subjects are reasonable in relation to anticipated benefits to subjects, and to the importance ofknowledge that may reasonably be expected to result.Yes No (a) What does the IRB consider the level of risk to be?Yes No (b) What does the Investigator consider the level of risk/discomfort/inconvenience to be?Yes No (c) Is there prospect of direct benefit to subjects?Yes No (d) Are risks minimized as much as possible?Yes No (e) Are foreseeable risks clearly defined, including likelihood, severity, and duration(including reversibility)?Yes No (f) Are the benefits clearly stated?3. Subject selection is equitable.Yes No (a) Who is to be enrolled? Men? Women? Ethnic minorities? Children (rationale forinclusion/exclusion addressed)? Seriously ill people? Healthy volunteers?Yes No (b) Are these subjects appropriate for the protocol?Yes No (c) Do the eligibility criteria minimize risks to subjects?Yes No (d) Are there groups of people who should be excluded from this study because they might bemore susceptible to risks presented in this research?Yes No (e) Would it be possible to conduct the study with less vulnerable subjects?Review Cklist.doc© 2004 by CRC Press LLC