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["様式　阪院－臨床12（2024.11改訂）",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"整理番号"]
["（生命・医学系指針_他機関用）",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"西暦　　　年　　月　　日"]
[]
["臨床研究終了報告書"]
[]
["独立行政法人国立病院機構大阪医療センター"]
["受託研究審査委員会第２委員会　委員長　殿"]
["院長　殿",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"研究責任者　所属・職名："]
[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,"氏名：",null,null,null,null,null,null,null,null,null,null,"印"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"今年度の教育・研修：",null,null,null,null,null,null,null,null,null,null,"□有　□無（不可）"]
["下記のとおり研究を終了しましたので報告します。"]
["記"]
["研究課題名"]
["研究期間",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,"終了日（当院）",null,null,null,null,"：","西暦　　　　　　年　　　　月　　　　日"]
["同意取得数（当院）",null,null,null,null,null,null,null,"文書により同意を取得する研究である（研究開始～報告時点までの全症例数を下記に記載すること）"]
[null,null,null,null,null,null,null,"文書同意取得数",null,null,null,null,null,null,null,null,"例",null,null,null,null,null,null,"同意取得後未実施数",null,null,null,"例",null,null,null,null,"同意撤回数",null,null,null,"例"]
[null,null,null,null,null,null,null,null,"文書同意が該当しない研究である"]
["実施症例数（当院）",null,null,null,null,null,null,"実施症例数",null,null,null,null,null,null,null,"例"]
[]
["倫理指針遵守状況\n",null,null,null,null,null,null,"◎研究計画書からの逸脱（倫理、安全性確保上問題のある逸脱）"]
[null,null,null,null,null,null,null,null,null,"なし",null,null,"あり→",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,"◎安全性（有害事象）の発現状況"]
[null,null,null,null,null,null,null,null,null,"侵襲を伴わない、又は、軽微な侵襲のみの研究である。"]
[null,null,null,null,null,null,null,null,null,"侵襲（軽微を超える）を伴う研究である。"]
[null,null,null,null,null,null,null,null,null,"⇒",null,"有害事象なし",null,null,null,null,null,"有害事象あり（非重篤）"]
[null,null,null,null,null,null,null,null,null,null,null,"重篤な有害事象あり⇒",null,null,null,null,null,null,null,"IRB報告済",null,null,null,null,"IRB報告未（速やかにIRBに報告すること）"]
[]
[null,null,null,null,null,null,null,"◎補償保険への加入"]
[null,null,null,null,null,null,null,null,null,"加入済",null,null,null,"未加入",null,null,null,"該当せず"]
[]
[null,null,null,null,null,null,null,"◎モニタリング・監査の実施"]
[null,null,null,null,null,null,null,null,null,"モニタリング実施が規定されている。"]
[null,null,null,null,null,null,null,null,null,"⇒",null,"実施/受入なし",null,null,null,null,null,"実施/受入あり（モニタリング報告書を添付すること）"]
[null,null,null,null,null,null,null,null,null,"モニタリング実施の規定がない。"]
[null,null,null,null,null,null,null,null,null,"⇒",null,"侵襲（軽微を超える）、介入研究ではないため該当しない。"]
[null,null,null,null,null,null,null,null,null,null,null,"「人を対象とする医学系研究に関する倫理指針」施行前に開始した研究である。"]
[null,null,null,null,null,null,null,null,null,null,null,"その他（",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,null,null,null,"監査実施が規定されている。"]
[null,null,null,null,null,null,null,null,null,"⇒",null,"実施/受入なし",null,null,null,null,null,"実施/受入あり（監査報告書を添付すること）"]
[null,null,null,null,null,null,null,null,null,"監査実施の規定がない。"]
["研究の結果\n（研究全体の結果を記載すること）\n",null,null,null,null,null,null,"【空欄不可】"]
[]
[]
[]
["発表\n（学会名・演題名・発表年月日／雑誌名・論文タイトル・ページ数も記載すること）",null,null,null,null,null,null,"【空欄不可】"]
[]
[]
[]
["添付書類",null,null,null,null,null,null,"モニタリング･監査：",null,null,null,null,null,null,"モニタリング報告書",null,null,null,null,null,null,"監査報告書"]
["公開データベースへの研究結果の登録",null,null,null,null,null,null,null,null,"登録済",null,null,null,"未対応→",null,null,"研究結果公開後、臨床研究の結果の公表に関する報告書（様式　阪院-臨床13）を提出すること"]
[null,null,null,null,null,null,null,null,null,"該当せず"]
["文書の保管期間\nについて",null,null,null,null,null,null,null,null,"西暦　　　　　　　年　　　　　月　　　　　日まで保管"]
[null,null,null,null,null,null,null,null,null,"※侵襲（軽微な侵襲を除く）を伴う介入研究は、少なくとも研究終了報告から5年を経過した日又は当該研究の結果の最終の公表について報告された日から3年を経過した日まで保管すること"]
[null,null,null,null,null,null,null,null,null,"保管期間未定(様式　阪院-臨床13結果の公表に関する報告書提出時に保管期間を明示する）"]