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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"□","医薬品",null,null,"□","医療機器",null,null,null,"□","再生医療等製品",null,null,null,null,null,"□","医療機器"]
[]
[null,"【新規治験依頼票】　新規予定治験・製造販売後臨床試験の実施確認事項"]
[]
[null,null,"この試験の調整医師",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," 治験責任医師：　　　　　　　　　　　　　　　　　　　　　　    "]
[null,null,"□","当センターの医師が担当",null,null,null,null,null,null,null,null,"□","他施設の医師が担当"]
[]
[null,"課題名："]
[]
[null," 課題名　略称："]
[null," 対象とする癌腫：",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," 実施診療科："]
[null,"特記事項："]
[null,"※特記事項には対象が、がん腫を特定しない臓器横断的なものや希少疾患の場合にご記入ください。"]
[null," 治験薬名：",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"□","完全新規薬剤",null,null,null,null,null,"□","がん腫適応拡大",null,null,null,null,null,null,"□","治療ラインの拡大"]
[null," 治験薬：",null,null,null,"□","免疫チェックポイント阻害薬（ICI)",null,null,null,null,null,null,null,null,null,null,"□","分子標的薬",null,null,null,null,"□","殺細胞性薬剤",null,null,null,null,null,"□","支持療法",null,null,null,"□","その他"]
[null,null,null,null,null,"特徴：　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　"]
[null,null,null,null,null,"※特徴には治験薬の特殊性についてご記載ください。（例えば、-80℃保存/ウィルスベクター製剤/カルタヘナ法適用/再生医療製品等）"]
[null," 治験実施計画書番号：",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," 治験依頼者："]
[null," CRO社名：",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," 国内管理人："]
[null," 治験の相：",null,null,null,null,"□","Ⅰ相",null,null,"□","Ⅰ/Ⅱ相",null,null,null,"□","Ⅱ相",null,null,"□","Ⅱ相前期",null,null,null,"□","Ⅱ相後期",null,null,null,"□","Ⅱ/Ⅲ相",null,null,null,"□","Ⅲ相",null,null,"□","Ⅳ相"]
[null,"段　　階：",null,null,null,null,"□","First in human",null,null,null,null,null,null,null,"□","First in Japanese",null,null,null,null,null,null,null," 国際共同治験：",null,null,null,null,null,"□","国内",null,"（参加施設数：",null,null,null,null,null,null,null,null,"）",null,"□","国際"]
[null," 目標とする症例数：",null,null,null,null,null,null,"▪試験全体：　　　　　　例　　▪日本国内：　　　　　例　　　▪当センターへの依頼：　　　　　例",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," 審査希望IRB（月）：    ",null,null,null,null,null,null,null,null,"月IRB"]
[null,"基本的確認事項","書式2に記載が必須なスタッフ",null,null,null,null,null,null,null,null,null,null,"□","無",null,null,"□","有（職種：　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　）※SI,CRC以外"]
[null,null,"盲検・非盲検スタッフの設定",null,null,null,null,null,null,null,null,null,null,"□","無",null,null,"□","盲検・非盲検医師",null,null,null,null,null,null,"□","盲検・非盲検スタッフ（職種：　　　　　　　　　　　　　　　　　　　　　　）"]
[null,null,"治験薬の投与方法",null,null,null,null,null,null,null,null,null,null,"□","経口",null,null,"□","点滴静注",null,null,null,"（インラインフィルターの使用",null,null,null,null,null,null,null,null,null,"□","無",null,"□","有）"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,"□","皮下注",null,null,"□","静注",null,null,"□","貼付",null,null,"□","その他（　　　　　　　　　　　　　　　　　　　　）　　　　　　　"]
[null,null,"治験薬投与",null,null,null,null,null,null,null,null,null,null,"投与期間：",null,null,null,null,null,null,null,null,null,null,"ヵ月",null,null,null,"入院・外来：",null,null,null,null,"□","外来",null,null,null,"□","入院外来どちらでも可"]
[null,null,"20歳未満の組み入れ",null,null,null,null,null,null,null,null,null,null,"□","無",null,null,"□","有","（対象年齢：　　　　　　",null,null,null,null,null,null,null,"歳",null,"～",null,null,null,"歳","）"]
[null,null,"治験期間",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"年",null,null,"月",null,null,"日",null,"～",null,null,null,null,null,"年",null,null,"月",null,null,"日"]
[null,null,"うちエントリー期間",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"年",null,null,"月",null,null,"日",null,"～",null,null,null,null,null,"年",null,null,"月",null,null,"日"]
[null,null,"血液検査：",null,null,null,"中央測定",null,null,null,"□","無",null,"□","有",null,"薬物動態採血",null,null,null,null,"□","無",null,"□","有",null,"その他の特殊検査（",null,null,null,null,null,null,null,null,null,null,null,null,null,"）","□","無",null,"□","有"]
[null,"≪備考≫"]

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