form ethical clearance 13 manusia

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Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada SOP 3.2- 008.2012-02 Effective date: 1 October 2012 Page1 of 7 3.2. Submission of Protocol for Initial Review ANNEX 1 AF 3.2.01-008.2012-02 Page 1 of 2 INITIAL REVIEW SUBMISSION FORM Protocol Title: Protocol No.: Total Participants to be included: STUDY TYPE: (Mark “ whichever apply to the study) Survey Social Medical Community based Individual based Screening Observational Epidemiology Intervention study Clinical Trial: Phase I Phase II Phase III Phase IV Genetic Study Retrospective Prospective Others…………………………… STUDY POPULATION: Healthy Patient Vulnerable groups CHARACTERISTICS of PARTICIPANTS PARTICIPATED: Age Range: 0 -17 yrs 18 - 44 yrs 45 - 65 yrs > 66 yrs Pediatric None < 1 yr 1-3 yrs 4 -14 yrs Impaired None Physically Cognitively Mentally REQUESTED EXCLUSION OF PARTICIPANTS: None Male Female Children Other (specify): SPECIAL RESOURCE REQUIREMENTS (check all that apply): Intensive Care Isolation unit Surgery Pediatric Intensive Care Transfusion CAT scan

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Medical and Health Research Ethics Committee(MHREC)Faculty of Medicine Universitas Gadjah MadaSOP 3.2-008.2012-02Effective date:1 October 2012Page1 of 53.2. Submission of Protocol for InitialReviewANNEX 1AF 3.2.0100!.201202Page 1 of 2INI"IA# RE$IE% S&'(ISSI)N F)R(Protocol TitleProtocol !o" Total Partici#ants to $e included%TU&' T'PE (Mar() ) *hichever a##ly to the study) SurveySocial Medical Cou!ity ba"ed #!dividual ba"ed Scree!i!g Ob"ervatio!al E$ideiology #!terve!tio! "tudy Cli!ical %rial:P&a"e # P&a"e ##P&a"e ### P&a"e #' (e!etic Study )etro"$ective Pro"$ective Ot&er"***********%TU&' P+PU,-T.+! +ealt&y Patie!t 'ul!erable grou$"CH-R-CTER.%T.C% of P-RT.C.P-!T% P-RT.C.P-TE&,ge )a!ge: 0 -1- yr" 18 - .. yr" .5 - /5 yr"0 // yr"Pediatric 1o!e 2 1 yr 1-3 yr" . -1. yr"#$aired 1o!e P&y"ically Cog!itively Me!tallyRE/UE%TE& E0C,U%.+! +F P-RT.C.P-!T% 1o!e Male 3eale C&ildre! Ot&er 4"$ecify5:%PEC.-, RE%+URCE RE/U.REME!T% (chec( all that a##ly) #!te!"ive Care #"olatio! u!it Surgery Pediatric #!te!"ive Care %ra!"fu"io! C,% "ca! (e!e t&era$y Co!trolled "ub"ta!ce" 41arcotic"6 P"yc&otro$ic"5 Pro"t&etic" (y!ecological "ervice" Ot&er"7 "$ecify*****. Orga! tra!"$la!tatio!7 "$ecify*********************..+!.1.!G R-&.-T.+! U%E (02rays3 radioisoto#es3 etc)1o!e Medically i!dicated o!ly.!4E%T.G-T.+!-, !E5 &RUG (.!&) 6 &E4.CE (.&E)1o!e #18 #8E38, 1o.:****** 38, 1o:********1ae:*******. 1ae:*********S$o!"or:******. S$o!"or:*******...+older:******* +older:********...9P POM 1o:****. 9P POM 1o:******PR+CE&URE U%E #!va"ive 1o!-i!va"ive MU,T.2%.TE C+,,-7+R-T.+!:ES 1OF.!-!C.-, &.%C,+%URE :ES 1OMedical and Health Research Ethics Committee(MHREC)Faculty of Medicine Universitas Gadjah MadaSOP 3.2-008.2012-02Effective date:1 October 2012Page2 of 53.2. Submission of Protocol for InitialReviewAF 3.2.0100!.201202Page 2 of 2INI"IA# RE$IE% S&'(ISSI)N F)R(P-RT.C.P-T.!G .!4E%T.G-T+R% (add e8tra #a9es if necessary)First 6 ,ast !ame ,icense !o" .nstitution Tele#hone 6 Fa8 !o"1.2.3...5.RE%E-RCHC+!T-CT1ae:******************************** #!"titute6,ddre"": *******************************%ele$&o!e:****************3a;:*******************E-ail:*****************...%.G!-TURE 8ate: ******.. Pri!ci$al #!ve"tigator" T'PE +F .!.T.-, RE4.E5 -%%.G!E& RE4.E5ER% E;e$ted fro revie< E;$edited )evie< 3ull 9oard )evie