stdClass Object ( [id] => 1122 [parent_id] => 1120 [site_id] => 6 [account_id] => 4 [rank] => 229 [release_kbn] => 1 [release_start_date] => [release_end_date] => [format_type] => fixedFormat [format_id] => [name] => 製造販売後調査 [catch] => [comment] => [meta_description] => [meta_keywords] => [directory_name] => seizohanbaigochosa [template_name] => 2column_fixedFormat.tpl [url] => https://www.jiaikai.or.jp/imamura-general/Specialized-department/rinshoshiken-shienshitsu/seizohanbaigochosa [page_limit] => 20 [delete_kbn] => [update_date] => 2024-12-06 16:44:10 [created_date] => 2022-05-13 17:32:00 [site_directory] => imamura-general [domain] => [uri] => /var/www/html/site/imamura-general/Specialized-department/rinshoshiken-shienshitsu/seizohanbaigochosa [structures] => host\cms\repository\pageStructureRepository Object ( [_status] => 1 [_message] => [_valid] => [_invalid] => [_lastId] => [select:host\cms\repository\dbRepository:private] => ps.*, m.module_theme, m.module_type, m.template, ac.name as account_name [from:host\cms\repository\dbRepository:private] => page_structure_tbl ps LEFT JOIN m_page_module_tbl m ON ps.module_id = m.id LEFT JOIN account_tbl ac ON ps.account_id = ac.id [where:host\cms\repository\dbRepository:private] => Array ( [0] => Array ( [0] => ps.delete_kbn IS NULL [1] => ps.site_id = :site_id [2] => ps.navigation_id = :navigation_id [3] => ps.release_kbn = :release_kbn AND (ps.release_start_date IS NULL || DATE_FORMAT(now(), '%Y-%m-%d') >= DATE_FORMAT(ps.release_start_date, '%Y-%m-%d')) AND (ps.release_end_date IS NULL || DATE_FORMAT(now(), '%Y-%m-%d') <= DATE_FORMAT(ps.release_end_date, '%Y-%m-%d')) ) ) [value:host\cms\repository\dbRepository:private] => Array ( [:site_id] => 6 [:navigation_id] => 1122 [:release_kbn] => 1 ) [page] => 0 [limit] => [order:host\cms\repository\dbRepository:private] => ps.rank ASC [group_by:host\cms\repository\dbRepository:private] => [explode_columns:host\cms\repository\dbRepository:private] => [explode_separator:host\cms\repository\dbRepository:private] => [json_decode_columns:host\cms\repository\dbRepository:private] => [rowNumber] => 1 [totalNumber] => 1 [pageNumber] => 0 [pageRange] => Array ( [0] => 0 ) [row] => Array ( [0] => stdClass Object ( [id] => 3346 [site_id] => 6 [navigation_id] => 1122 [module_id] => [account_id] => 42 [rank] => 0 [release_kbn] => 1 [release_start_date] => 2023-07-03 [release_end_date] => [name] => ページ案 [html] => <div class="conatiner mb-5 pb-5"> <div> <p class="text-center fs-3 fw-bold my-5 mb-0"><span class="text-white py-3 px-md-5 px-3 shadow" style="background-color:#f68b1f">製造販売後調査実施の流れ </span></p> <div class="row justify-content-center mt-5"> <div class="col-md-10 text-danger fs-5 fw-bold">製造販売後調査を実施するには、実施する診療科主任部長の内諾及び当院薬事委員会の承認が必要です。</div> </div> <div class="row justify-content-start mt-5"> <div class="col-lg-4"> <p class="py-2 text-center mb-0 text-white w-100 fs-5 fw-bold shadow" style="background-color:#f68b1f">1.実施診療科との事前相談</p> </div> <div class="col-lg-8 mt-lg-0 mt-3"> <div class="p-3" style="background-color:#FEE3CA"> <p class="mb-0 fs-5">診療科主任部長に調査概要、調査票作成経費等をご説明のうえ、製造販売後調査実施の内諾を得られてください。</p> </div> </div> </div> <div class="row justify-content-center mt-5"> <div class="col-xl-8 col-md-10 fs-5 text-center"><span class="border-bottom border-dark">契約締結の事務手続きは臨床試験支援室で行います。</span></div> </div> <div class="row justify-content-center mt-5"> <div class="col-lg-4"> <p class="py-2 text-center mb-0 text-white w-100 fs-5 fw-bold shadow" style="background-color:#f68b1f">2.契約手続き</p> <p class="mb-0 mx-xl-5 mx-lg-3 mx-5 text-center fw-bold mt-lg-5 mt-3 py-2" style="background-color:#FECFA4;border:solid 2px #FE800C;"><span class="fs-5">(1)関連書類の入手</span></p> </div> <div class="col-lg-8 mt-lg-0 mt-3"> <div class="p-3 fs-5" style="background-color:#FEE3CA"> <p class="mb-0">必要事項を記入した以下の書類及び資料を専用メール宛てにご提出ください。症例登録のみの場合は該当箇所を記入の上、ご提出ください。</p> <div class="row justify-content-center"> <div class="col-md-11"> <p class="mb-0"><a download="製造販売後調査申込書.docx" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/書式1 製造販売後調査申込書.docx" id="syosiki-1" onclick="return showConfirmation();">①<span class="border-bottom border-dark">製造販売後調査申込書（書式1）</span></a></p> <p class="mb-0"><a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/書式2 製造販売後調査契約書(二者間用）.docx">②<span class="border-bottom border-dark">製造販売後調査実施契約書（二者間用）（書式2）</span></a></p> <p class="mb-0"><a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/書式2　製造販売後調査契約書（三者間用）.docx">②<span class="border-bottom border-dark">製造販売後調査実施契約書（三者間用）（書式2）</span></a></p> <p class="mb-0"><a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/製造販売後調査　分担医師リスト.doc">③<span class="border-bottom border-dark">調査分担医師リスト（分担医師不在の場合は提出不要）</span></a></p> <p class="mb-0">④調査実施計画書（実施要綱）、同意説明文書　等</p> </div> </div> </div> </div> </div> <div class="row justify-content-center align-items-center mt-3"> <div class="col-lg-4"> <p class="mb-0 mx-xl-5 mx-lg-3 mx-5 text-center fw-bold py-2" style="background-color:#FECFA4;border:solid 2px #FE800C;"><span class="fs-5">(2)依頼・申請</span></p> </div> <div class="col-lg-8 mt-lg-0 mt-3"> <div class="p-3" style="background-color:#FEE3CA"> <p class="mb-0 fs-5">調査票作成においては別途事務経費が発生致します。契約書に記載いただく調査費用については、製造販売後調査申込書に記載しております調査委託費をご参照のうえ、 内訳までご記載ください。</p> <p class="mt-3 mb-0 fs-5">依頼者様に<a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/3%20%E8%A3%BD%E9%80%A0%E8%B2%A9%E5%A3%B2%E5%BE%8C%E8%AA%BF%E6%9F%BB%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E7%B5%8C%E8%B2%BB%E7%AE%97%E5%87%BA%E5%9F%BA%E6%BA%96%E7%A2%BA%E8%AA%8D%E6%9B%B8%281%29.pdf"><span class="border-bottom border-dark">経費算出基準確認書（書式3）</span></a>をお渡し致します。</p> </div> </div> </div> <div class="row justify-content-center align-items-center mt-3"> <div class="col-lg-4"> <p class="mb-0 mx-xl-5 mx-lg-3 mx-5 text-center fw-bold py-2" style="background-color:#FECFA4;border:solid 2px #FE800C;"><span class="fs-5">(3)契約</span></p> </div> <div class="col-lg-8 mt-lg-0 mt-3"> <div class="p-3" style="background-color:#FEE3CA"> <p class="mb-0 fs-5">内容を確認後、問題がなければ契約書押印の手続きを行います。</p> </div> </div> </div> <div class="row justify-content-center align-items-start mt-5"> <div class="col-lg-4"> <p class="py-2 text-center mb-0 text-white w-100 fs-5 fw-bold shadow" style="background-color:#f68b1f">3.調査の実施</p> </div> <div class="col-lg-8 fs-5 mt-lg-0 mt-3"> <div class="p-3" style="background-color:#FEE3CA"> <p class="mb-0">調査票の回収やEDCシステムに関するお問い合わせは、各診療科へお願い致します。</p> </div> <div class="p-3 mt-3" style="background-color:#FEE3CA"> <p class="mb-0">調査中に変更が生じた場合には、<a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/書式4 製造販売調査に関する変更申請.docx"><span class="border-bottom border-dark">製造販売後調査契約に関する変更依頼書（書式4）</span></a>を臨床試験支援室までご提出ください。<br /> 登録期間の延長、症例追加、調査責任医師の変更等が生じた場合は、<span class="border-bottom border-dark">覚書</span>にて対応致します。</p> <p class="mb-0"><a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/書式5 覚書（二者用）.docx"><span class="border-bottom border-dark">覚書（二者間用）（書式5）</span></a></p> <p class="mb-0"><a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/書式5 覚書（三者用）.docx"><span class="border-bottom border-dark">覚書（三者間用）（書式5）</span></a></p> </div> <div class="p-3 mt-3" style="background-color:#FEE3CA"> <p class="mb-0">登録のみへ移行の場合、院長宛てのレターのご提出をお願い致します。</p> </div> </div> </div> <div class="row justify-content-center align-items-start mt-5"> <div class="col-lg-4"> <p class="py-2 text-center mb-0 text-white w-100 fs-5 fw-bold shadow" style="background-color:#f68b1f">4.調査の終了</p> </div> <div class="col-lg-8 mt-lg-0 mt-3"> <div class="p-3" style="background-color:#FEE3CA"> <p class="mb-0 fs-5">調査が終了した場合は、<a download="" href="https://www.jiaikai.or.jp/imamura-general/design/default/files/word/書式6 製造販売後調査終了報告書.docx"><span class="border-bottom border-dark">終了報告書（書式6）</span></a>を臨床試験支援室までご提出ください。<br /> 調査が中止になった場合、登録のみの場合も同様です。また、症例の登録がなかった場合もご提出ください。</p> </div> </div> </div> <div class="row justify-content-center align-items-start mt-5"> <div class="col-lg-4"> <div class="mb-0 fw-bold fs-5 py-2 shadow" style="background-color:#FECFA4;border:solid 2px #FE800C;"> <p class="text-lg-start text-center mb-0 px-3">その他</p> <p class="text-center mb-0">ご注意いただきたいこと</p> </div> </div> <div class="col-lg-8 mt-lg-0 mt-3"> <div class="p-3" style="background-color:#FEE3CA"> <ul class="mb-0"> <li class="fs-5">調査票作成を伴わない登録のみの場合も契約は必須です。</li> <li class="fs-5 mt-3">データの管理や費用管理に関する業務、契約に関する業務等を委託される場合は、三者間契約を締結致します。</li> <li class="fs-5 mt-3">調査費用の支払いは年度毎の実績に応じて、臨床試験支援室にて請求書を発行致します。期日までにお振込みくださいますようお願い致します。</li> <li class="fs-5 mt-3">調査に関わるすべての業務は、契約期間内に終了するようお願い致します。</li> </ul> </div> </div> </div> </div> <div class="mt-5 p-3 p-lg-5" style="border:solid 4px #FE800C;"> <p class="fs-3">【契約及び資料送付に関する窓口】</p> <div class="d-lg-flex"> <div class="fs-5">今村総合病院 臨床試験支援室　</div> <div class="fs-5"> <div> <p><a href="tel:099-253-9930">連絡先（ダイヤルイン）：099-253-9930（内線：2352）</a><br /> <span class="ms-3">＊ご連絡は平日 9：00～17：00にお願い致します。</span></p> </div> <div> <p><span class="border-dark border-bottom">専用e-mail：<a class="text-primary" href="mailto:imamura_pms@jiaikai.jp">imamura_pms@jiaikai.jp</a></span><br /> <span class="ms-3">＊メールでの対応が難しい際には郵送でお送りください。</span></p> </div> </div> </div> </div> </div> [meta_description] => [meta_keywords] => [delete_kbn] => [update_date] => 2024-10-11 12:01:27 [created_date] => 2023-06-16 12:43:40 [module_theme] => [module_type] => [template] => [account_name] => 今村総合病院 CRC [data] => stdClass Object ( ) ) ) [post] => [id] => [site_id] => 6 [navigation_id] => 1122 [module_id] => [release_kbn] => 1 [site_uri] => [preview_page_post] => [preview_structure_post] => ) [elements] => host\cms\repository\pageRepository Object ( [_status] => [_message] => [_valid] => [_invalid] => [_lastId] => [select:host\cms\repository\dbRepository:private] => p.*, n.directory_name, n.parent_id [from:host\cms\repository\dbRepository:private] => page_tbl p LEFT JOIN page_content_tbl c ON p.site_id = c.site_id AND p.id = c.page_id LEFT JOIN navigation_tbl n ON p.site_id = n.site_id AND p.navigation_id = n.id [where:host\cms\repository\dbRepository:private] => Array ( [0] => Array ( [0] => p.delete_kbn IS NULL AND c.delete_kbn IS NULL [1] => p.site_id = :site_id [2] => p.navigation_id = :navigation_id [3] => p.release_kbn = :release_kbn AND (p.release_start_date IS NULL || now() >= p.release_start_date) AND (p.release_end_date IS NULL || now() <= p.release_end_date) ) ) [value:host\cms\repository\dbRepository:private] => Array ( [:site_id] => 6 [:navigation_id] => 1122 [:release_kbn] => 1 ) [page] => 0 [limit] => [order:host\cms\repository\dbRepository:private] => p.release_start_date DESC [group_by:host\cms\repository\dbRepository:private] => p.id [explode_columns:host\cms\repository\dbRepository:private] => [explode_separator:host\cms\repository\dbRepository:private] => [json_decode_columns:host\cms\repository\dbRepository:private] => [rowNumber] => 0 [totalNumber] => 0 [pageNumber] => 0 [pageRange] => Array ( [0] => 0 ) [row] => Array ( ) [post] => [id] => [site_id] => 6 [navigation_id] => 1122 [navigation_ids] => [format_type] => [page_id] => [release_kbn] => 1 [content_id] => [field_id] => [field_value] => [module_id] => [content_type] => [content_value] => [content_values] => [keyword] => [preview_post] => [page_url] => ) ) 1