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In Northern Ireland, Scotland and Wales, NHS/HSC R&D offices will be informed. What Happens Next? Please set up the new site(s) as per the guidance found within IRAS <https://www.myresearchproject.org.uk/help/hlpnhshscr.aspx> . Please note that processes change from time to time so please use the most up to date guidance about site set up. If your study is supported by a research network, please contact the network as early as possible to help support set up of the new site(s). IRAS Project ID: 209688 Short Study Title: OPTIMISE II Date complete amendment submission received: 18/08/217 Sponsor Amendment Reference Number: Minor amendment 2 Sponsor Amendment Date: 17/08/2017 Amendment Type Non-substantial For new sites in Northern Ireland, Scotland and/or Wales only: Please start to set up your new sites. Sites may not open until NHS management permission is in place. For new sites in England only: For studies which already have HRA Approval: This email also constitutes HRA Approval for the amendment, and you should not expect anything further from the HRA. Please start to set up your new sites. Sites may not open until the site has confirmed capacity and capability (where applicable). For studies which do not yet have HRA Approval: HRA Approval is pending and you will receive confirmation of HRA Approval. You can start the process of setting up the new site but cannot open the study at the site until HRA Approval is in place and the site has confirmed capacity and capability (where applicable). If you have any questions relating to setting up sites in England, please direct these to hra.approval@nhs.net <mailto:hra.approval@nhs.net> . If you have any questions relating to setting up sites in Northern Ireland, Scotland or Wales, please direct these to the relevant national coordinating function <https://www.myresearchproject.org.uk/help/hlpnhshscr.aspx> . Note: you may only implement changes described in the amendment notice. Please do not hesitate to contact me if you require further information. Kind regards Ali Hussain Amendments Co-ordinator Health Research Authority HRA, Ground Floor, Skipton House, 80 London Road, London, SE1 6LH E: hra.amendments@nhs.net <mailto:hra.approval@nhs.net> : T: 020 7972 2649 www.hra.nhs.uk <http://www.hra.nhs.uk/> The HRA is keen to know your views on the service you received  our short feedback form is available here <http://www.hra.nhs.uk/about-the-hra/governance/quality-assurance/> From: Priyanthi Dias [mailto:p.dias@qmul.ac.uk] Sent: 18 August 2017 10:54 To: AMENDMENTS, Hra (HEALTH RESEARCH AUTHORITY) Cc: Ornelas, Safia (RGC) Development Administrator; Doris Lanz Subject: OPTIMISE II IRAS Project ID: 209688; REC Ref: 16/LO/2067 - Minor Amendment 2 Dear HRA Amendments, Please find attached the supporting documentation for a non-substantial amendment to add a new site to the OPTIMISE II trial. Thank you and kind regards, Priya Senior Trials Coordinator ACCU Research Offices 4th Floor, Office 14 Royal London Hospital Whitechapel London E1 1BB Tel: +44 (0)20 3594 0349 Fax: +44 (0)20 3594 3140 *********************************************************************** ********************************************* This message may contain confidential information. If you are not the intended recipient please inform the sender that you have received the message in error before deleting it. Please do not disclose, copy or distribute information in this e-mail or take any action in relation to its contents. To do so is strictly prohibited and may be unlawful. Thank you for your co-operation. NHSmail is the secure email and directory service available for all NHS staff in England and Scotland. NHSmail is approved for exchanging patient data and other sensitive information with NHSmail and other accredited email services. 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F2NzQPXagi2wsRNXkwy/m4JCasMra3uUiySLxHopolOOnHd1HXynZ01Ax2vkzQf+gw /LpAoSY/NCWlysp73cFFnekeq/MQRv2yv1U9rz1Y= Received: from NH-SLPEX016.AD1.NHS.NET (unknown [192.168.66.70]) by smtp1.e.amses.net (Postfix) with ESMTPS id 639035EC66B; Mon, 28 Aug 2017 15:47:35 +0100 (BST) Received: from NH-SLPEX016.AD1.NHS.NET (192.168.218.26) by NH-SLPEX016.AD1.NHS.NET (192.168.218.26) with Microsoft SMTP Server (TLS) id 15.0.1210.3; Mon, 28 Aug 2017 15:47:47 +0100 Received: from NH-SLPEX016.AD1.NHS.NET ([fe80::2d1f:1ed0:c98d:3f7b]) by NH-SLPEX016.AD1.NHS.NET ([fe80::2d1f:1ed0:c98d:3f7b%17]) with mapi id 15.00.1210.000; Mon, 28 Aug 2017 15:47:47 +0100 From: "AMENDMENTS, Hra (HEALTH RESEARCH AUTHORITY)" <hra.amendments@nhs.net> To: Priyanthi Dias <p.dias@qmul.ac.uk>, "Rupert Pearse (r.pearse@qmul.ac.uk)" <r.pearse@qmul.ac.uk> CC: "Ornelas, Safia (RGC) Development Administrator" <Safia.Ornelas@bartshealth.nhs.uk>, Doris Lanz <d.lanz@qmul.ac.uk> Subject: RE: OPTIMISE II Amendment 16/LO/2067/AM03 , IRAS 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