ࡱ> JLI V1bjbj E8}c}c v v 8 | .ttt@ B B B B B B $"$Vf 9tttttf  t:@ t@ Pl^,  0 &&&tttttttf f ttt tttt&tttttttttv : ū Institutional Review Board SCIENTIFIC REVIEW WORKSHEET Scientific Reviewers can use this worksheet to systematically assess the scientific quality of a study prior to approving its submission to the IRB. Completed forms need not be submitted to the IRB. IRB #: PROTOCOL TITLE: PRINCIPAL INVESTIGATOR: ELEMENTREVIEWER RECOMMENDATIONS/COMMENTSINVESTIGATOR RESPONSEAre the objectives/hypotheses clearly stated and testable? Does the background section provide adequate information to judge the scientific merit of the proposed research? Has an appropriate search of the literature been completed to preclude unnecessary duplication of previous research? Is the experimental design (e.g., RCT, cohort study, cross-sectional study, etc.) adequate and appropriate for the study objective? Are the research methods clearly and sequentially stated? Is the chosen study population well-defined and appropriate for the study objective? Are the inclusion and exclusion criteria adequate? Is it clear how each variable will be defined operationally and from where each variable will be gathered? (For example, the variable chronic kidney disease may be defined in a study as  present if the subject has a GFR d" 60 cc/min/1.73 m2, as estimated by the MDRD equation using serum creatinine drawn within 30 days of enrollment and abstracted from CHCS,  absent if GFR is >60, and  missing if serum creatinine was not drawn during those dates.) Are there case report forms/data collection sheets/instruments provided onto which data will be systematically recorded? Has a power analysis been conducted? Are the assumptions on which the power analysis is based stated explicitly, and are they reasonable?Is the primary outcome measure stated clearly, and is it appropriate for the study objective? Are the statistical methods for anal<    2 6    k l   - X Z [ ʹʹʹʧەۄwwۄwwfwww h<HhJCJOJQJ^JaJh<HhtOJQJ^J h<HhtCJOJQJ^JaJ#h<Hh{5CJOJQJ^JaJ#h<Hhgd65CJOJQJ^JaJ h<HhFY,CJOJQJ^JaJ h<Hhgd6CJOJQJ^JaJ#h<Hht5CJOJQJ^JaJ#h<HhYy5CJOJQJ^JaJ(;<   6 $ (l$If]^`la$gd2 $$Ifa$gd2gd2$a$gdQ*q$a$gd2     pgggg $Ifgd2kd$$Ifl2F(8& t09    44 la^yt2  riiii $Ifgd2kd$$IflF(8& t09    44 la^yt2     riiii $Ifgd2kd*$$IflF(8& t09    44 la^yt2 riiii $Ifgd2kd$$IflF(8& t09    44 la^yt2 riiii $Ifgd2kdP$$IflF(8& t09    44 la^yt2 W X Y Z riiii $Ifgd2kd$$IflF(8& t09    44 la^yt2Z [ "#$%riiii $Ifgd2kdv$$IflF(8& t09    44 la^yt2#%&e-/00|000111F1G1H1I1K1L1N1O1Q1R1U1V1ʽʽʽʽܪʽʽʽܢhBxjhBxUU h<Hh53CJOJQJ^JaJh<HhtOJQJ^J#h<Hht5CJOJQJ^JaJ h<HhtCJOJQJ^JaJ#h<HhtCJH*OJQJ^JaJ"%&ri`WW $Ifgd2 $Ifgd53 $IfgdCa9kd $$IflF(8& t09    44 la^yt2-./ri`` $Ifgd2 $Ifgd53kd$$IflF(8& t09    44 la^yt2/0riiii $Ifgd2kd/$$IflF(8& t09    44 la^yt2{0|0}0~000riiiiii $Ifgd2kd$$IflF(8& t09    44 la^yt2ysis stated clearly, and are they appropriate for the study objective? Should this study undergo review by a statistician?  Is the principal investigator appropriately trained to conduct this study? Has the investigator brought appropriate expertise to the research team? 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