From: AMENDMENTS, Hra (HEALTH RESEARCH AUTHORITY) Sent: 26 June 2017 13:32 To: Foster C.L. Cc: Horizons; Horizons; Cole A.B.; NRSPCC, Nhsg (NHS GRAMPIAN) Subject: IRAS 202342 New Site amendment - Non CTIMP Attachments: 16_NW_0425_AM07_ChecklistDownload-2017-06-26-13_30_52.zip A Dear Professor Foster Thank you for submitting an amendment to add one or more new sites to your project If you have listed new sites in any other UK nations we will forward the information to the national coordinating function(s) for nations where the new site(s) are being added. 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. 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: 202342 Short Study Title: HORIZONS: Understanding the impact of cancer diagnosis and treatment Date complete amendment submission received: 12 June 2017 Sponsor Amendment Reference Number: Non Substantial Amendment 2 (AM07) Sponsor Amendment Date: 7 June 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 . 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. 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 Kirsten Kirst en Pec k | H RA Appr oval Ame ndm ent Co- ordi nato r Heal th Res earc h Aut hori ty Brist ol H RA Cent re, Leve l 3, Bloc k B, Whit efria rs, Lewi ns M ead, Brist ol, B S1 2NT e- mail: kirst en.p eck @nh s.net T: 020 710 480 51 www .hra. nhs. uk IMP OR TA NT – Clic k her e for the late st deta ils of the roll- out of HR A App rova l in Engl and The HR A is kee n to kno w your view s on the serv ice you rece ived – our shor t feed bac k form is avai labl e her e ***************************************************************************** *************************************** 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 reliance on 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. NHSmail provides an email address for your career in the NHS and can be accessed anywhere For more information and to find out how you can switch, visit http://support.nhs.net/joiningnhsmail ***************************************************************************** ***************************************