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["Request For Quotation"]
[]
[" ※ 노란색 음영 표기된 칸을 필히 기재해주십시오. 작성하신 후 bd@kcsg.org로 메일을 보내주시기 바랍니다."]
["Study Type","Select"]
["Sponsor","Company or Institution Name"]
[null,"Department :",null,null,null,null,null,null,"Email :"]
[null,"Name :",null,null,null,null,null,null,"Tel :"]
["Contact Person","Department :",null,null,null,null,null,null,"Email :"]
[null,"Name :",null,null,null,null,null,null,"Tel :"]
[]
["1. Study Information"]
["KCSG Study No.",null,null,null,null,null,null,null,"Comments :",null,"KCSG Study No. 없는 경우, 사유를 기재해주십시오."]
["Protocol Title"]
["Study Phase","Select",null,null,null,null,null,null,"Comments :",null,"Other로 선택하신 경우, Study 종류를 기재해주십시오.",null,null,"Comments :"]
["Target No. of Subjects",null,null,null,null,"Subjects",null,null,"Comments :"]
["Estimated Schedule","Milestone",null,null,null,"Target End Date",null,null,"Comments"]
[null,"Protocol Development",null,null,null,"YYYY",null,"MM"]
[null,"IND Submission",null,null,null,"YYYY",null,"MM"]
[null,"IND Approval",null,null,null,"YYYY",null,"MM"]
[null,"IRB Initial Submission",null,null,null,"YYYY",null,"MM"]
[null,"FPI (First Patient In)",null,null,null,"YYYY",null,"MM"]
[null,"LPI (Last Patient In)",null,null,null,"YYYY",null,"MM"]
[null,"Treatment & Follow-up",null,null,null,"YYYY",null,"MM"]
[null,"DB Lock",null,null,null,"YYYY",null,"MM"]
[null,"CSR Wrting",null,null,null,"YYYY",null,"MM"]
["Current Study Status","위 Estimated Schedule의 Milestone 중 현재 해당되는 단계를 기재하십시오."]
["No. of Sites","서울/경기",null,null,null,"Sites",null,null,"Comments :"]
[null,"그외",null,null,null,"Sites"]
["Funding Information","Funding 여부",null,null,null,"Select",null,null," ※ Funding 여부에서 Yes를 선택하신 경우, 아래 Types of Funding을 필히 선택해주십시오."]
[null,"Types of Funding",null,null,null,null,"연구비",null,"Funding Source1",null,"Company Name"]
[null,null,null,null,null,null,"약제",null,"Funding Source2",null,"Company Name"]
[null,null,null,null,null,null,"기타 :","Fill in","Funding Source3",null,"Company Name"]
["CRF Type",null,"Paper CRF",null,null,null,"eCRF"]
["Comments"]
[]
["2. Scope of Tasks"]
["Full Scope","Select",null,null,null,"  ※ Full Scope 여부에서 Yes를 선택하신 경우, 아래에 나타나는 노란색 음영 칸을 필히 기재해주십시오."]
[" ※ Full Scope이 아닌 경우, 아래의 업무 중 위탁할 업무 범위를 선택해주십시오."]
["Study Management",null,"Overall Study Management"]
[null,null,"Kick-off Meeting",null,null,null,"Project Meeting with Sponsor",null,null,"Investigator Meeting",null,null,null,"Other Meeting :","Fill in"]
[null,null,"Newsletter",null,null,null,"Providing SAE Tracker"]
[null,null,"TMF Set-up & Management"]
[null,null,"Clinicaltrial.gov Registration"]
["Documents",null,"Protocol Development",null,null,null,"Protocol Amendment"]
[null,null,"ICF Development",null,null,null,"ICF Amendment"]
[null,null,"CRF Development",null,null,null,"CRF Amendment"]
[null,null,"Other Documents :","Fill in"]
["Regulatory Affairs\n(MFDS)",null,"MFDS IND Initial Submission",null,null,null,"MFDS IND Amendment Submission"]
[null,null,"MFDS Study Annual Progress Reporting"]
[null,null,"MFDS Other Reporting (FPE, LPE, Closing, Results, Amendment etc.)"]
["Site Management",null,"Site Feasibility (SIT의 경우)",null,null,null,"Pre-study Site Visit (SIT의 경우)"]
[null,null,"IRB Submission",null,null,null,"IRB 심의비 지급"]
[null,null,"Support for Submission to HIRA (요양급여)"]
[null,null,"Site Contract",null,null,null,"기관 연구비 지급"]
[null,null,"ISF Set-up & Distribution"]
[null,null,"Site Initiation Visit",null,null,"SIV Format",null,"Select"]
[null,null,"Site Monitoring Visit (SMV) ",null,null,"No. of SMV",null,"기관당 연 N 회","SDV",null,"Select",null,"Pharmacy Monitoring",null,"Select"]
[null,null,"Site Close-Out Visit"]
["Safety Management\n(Pharmacovigilance)",null,"SMP (Safety Management Plan)"]
[null,null,"MFDS SUSAR Reporting (Preparation)"]
[null,null,"MFDS DSUR Reporting"]
["Data Management",null,"EDC System","Select",null,":","Fill in","  ※ 기타를 선택한 경우, 어떤 EDC System을 사용할 예정인지 기재해주십시오."]
[null,null,"Data Management"]
[null,null,"External Data Handling",null,null,null,"EDC 내 Random Code 부여",null,null,"SAE Report 장착 :","Select"]
[null,null,"Raw Data Handling (논문 작성 시, 필요한 Data Summary를 위한 Data 가공 업무)"]
[null,null,"Interim Analysis",null,null,null,"Additional Analysis : ","Fill in"]
["Statistics",null,"Statistics Analysis ",null,null,null,"Randomization"]
["CSR",null,"CSR Writing"]
[]
["Optional Scope","  ※ 아래의 업무 중 위탁할 업무 범위를 선택해주십시오."]
["Vendor",null,"임상시험보증보험",null,null,null,"IP (Vendor Name : ",") ",null,"Central Lab (Vendor Name :",null,") ",null,"Other (Vendor Name :  ",null,") "]
["Translation",null,"번역이 필요한 문서의 종류를 기재해주십시오. (예, IRB 승인 통지서, Protocol 등)"]
["Miscellaneous",null,"Audit",null,null,null,"IDMC (Independent Data Monitoring Committee)"]