{"text_format":"1","workbook":"xlsx","n_sheets":1,"sheets":["実施状況報告書"],"not_rendered":{"charts":0,"images":0,"macros":1,"external_links":0,"defined_names":1,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"実施状況報告書","index":0,"n_rows":60,"n_cols":37,"rows_kept":60,"cut":false,"hidden":false,"merged":[[9,0,9,34],[10,0,10,6],[10,7,10,36],[4,0,4,11],[0,23,0,26],[0,27,0,36],[1,23,1,36],[3,0,3,11],[2,0,2,36],[7,15,7,25],[5,26,5,36],[6,26,6,35],[7,26,7,36],[8,0,8,34],[16,33,16,35],[15,0,17,6],[18,0,18,6],[16,24,16,26],[18,11,18,14],[18,30,18,33],[18,21,18,24],[16,12,16,15],[11,0,12,6],[12,8,12,35],[13,0,14,6],[13,8,13,18],[13,22,13,33],[60,0,60,36],[51,14,51,33],[20,0,29,6],[28,8,28,35],[25,8,25,35],[30,0,56,6],[31,15,31,32],[57,0,59,6],[26,7,27,36]]}
["様式　阪院－臨床９",null,null,null,null,null,null,null,"（2018.8改訂）",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"整理番号"]
[null,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"]
["臨床研究実施状況報告書"]
["独立行政法人　国立病院機構"]
["大阪医療センター　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,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,"印"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"臨床研究セミナー受講番号："]
["下記のとおり研究の実施状況を報告します。"]
["記"]
["研究課題名",null,null,null,null,null,null,""]
["臨床試験登録",null,null,null,null,null,null,"介入研究で、承認申請時に未登録の課題は記載必須"]
[]
["研究期間",null,null,null,null,null,null,null,"西暦　　　　　年　　月　　日",null,null,null,null,null,null,null,null,null,null,null,"～",null,"西暦　　　　　年　　月　　日"]
[null,null,null,null,null,null,null,null,null,null,null,null,"研究期間延長の有無",null,"なし",null,null,"あり⇒変更申請がまだの場合は直ちに研究変更報告書を提出すること"]
["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（内訳 ： 実施中",null,null,null,null,null,null,null,null,null,"例、終了・中止",null,null,null,null,null,null,null,null,"例）"]
[]
["進捗状況",null,null,null,null,null,null,"◎現在の状況"]
[null,null,null,null,null,null,null,null,null,"登録中",null,null,null,"登録終了、観察中",null,null,null,null,null,null,"データ収集中（非登録研究）",null,null,null,null,null,null,null,null,null,"観察終了、解析中"]
[null,null,null,null,null,null,null,"◎当院での進捗状況"]
[null,null,null,null,null,null,null,null,null,"計画通りの進捗である",null,null,null,null,null,null,null,"計画通りに進捗していない(注1)"]
[null,null,null,null,null,null,null,null,"(注1)「計画通りに進捗していない」又は「同意取得数0例」の場合は、下記に理由を記載すること。"]
[]
[null,null,null,null,null,null,null,"◎研究全体の進捗状況、発表等　　【空欄不可】\n（発表については、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。）"]
[]
[]
[]
["倫理指針遵守状況\n(研究の実施状況)",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,"◎研究実施計画書の変更"]
[null,null,null,null,null,null,null,null,null,"なし",null,null,"あり",null,"→",null,"IRB報告済",null,null,null,null,"IRB未報告（速やかに研究変更報告書を提出すること）"]
[]
[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。"]
[]
["添付書類",null,null,null,null,null,null,"同意書管理：",null,null,null,null,null,null,"同意書（すべての原本）",null,null,null,null,null,null,null,null,"被験者識別対応表（臨床10）の写し"]
[null,null,null,null,null,null,null,"個人情報取扱状況：",null,null,null,null,null,null,"登録票の写し",null,null,null,null,null,"CRF、EDC入力データの写し",null,null,null,null,null,null,null,"（過去1年間の登録例中1例分）"]
[null,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"]