Return-Path: X-Original-To: admin@optimiseii.org Delivered-To: admin@optimiseii.org Received: from dedivps-30230.dedicloud.co.uk (localhost [IPv6:::1]) by dedivps-30230.dedicloud.co.uk (Postfix) with ESMTPSA id 9178814B6839 for ; Wed, 23 Jan 2019 11:28:27 +0000 (UTC) Received: from [185.49.74.145] ([185.49.74.145]) by webmail.optimiseii.org (Horde Framework) with HTTP; Wed, 23 Jan 2019 11:28:27 +0000 Date: Wed, 23 Jan 2019 11:28:27 +0000 Message-ID: <20190123112827.Horde.GarMAFScfHQjfmiHrmfOJ1U@webmail.optimiseii.org> From: admin@optimiseii.org To: admin@optimiseii.org Subject: Fwd: IRAS 209688. Amendment categorisation and implementation information User-Agent: Horde Application Framework 5 Content-Type: text/plain; charset=utf-8; format=flowed; DelSp=Yes MIME-Version: 1.0 Content-Disposition: inline Content-Transfer-Encoding: 8bit ________________________________ From: hra.amendments@nhs.net Sent: Wednesday, July 11, 2018 2:31 pm To: Priyanthi Dias Cc: Rupert Pearse; Ann Thomson; nhsg.nrspcc@nhs.net; sponsorsrep@bartshealth.nhs.uk Subject: IRAS 209688. Amendment categorisation and implementation information Amendment Categorisation and Implementation Information Dear Priyanthi Dias, IRAS Project ID: 209688 Short Study Title: OPTIMISE II Date complete amendment submission received: 10/07/2018 Amendment No./ Sponsor Ref: NSA 5 - proposed change in the Patient Information Sheet and Informed Consent Form used by the Scottish sites only Amendment Date: 10 July 2018 Amendment Type: Non-substantial Outcome of HRA and HCRW Assessment This email also constitutes HRA and HCRW Approval for the amendment,and you should not expect anything further. Implementation date in NHS organisations in England and/or Wales 35 days from date amendment information together with this email, is supplied to participating organisations(providing conditions are met). Implementation date in NHS/HSC organisations in Northern Ireland and/or Scotland 13th August 2018 (providing conditions are met) For NHS/HSC R&D Office information Amendment Category B Thank you for submitting an amendment to your project. We have now categorised your amendment and please find this, as well as other relevant information, in the table above. What should I do next? Please read the information in IRAS, which provides you with information on how and when you can implement your amendment at NHS/HSC sites in each nation, andwhat actions you should take now. If you have participating NHS/HSC organisations in any other UK nations please note thatwe will forward the amendment submission to the relevant national coordinating function(s). If not already provided, please email to us any regulatory approvals (where applicable) once available. When can I implement this amendment? You may implement this amendment in line with the information inIRAS. Please note that you may only implement changes described in the amendment notice. Who should I contact if I have further questions about this amendment? If you have any questions about this amendment please contact the relevant national coordinating centre for advice: * England – hra.amendments@nhs.net * Northern Ireland – research.gateway@hscni.net * Scotland – nhsg.NRSPCC@nhs.net * Wales – research-permissions@wales.nhs.uk Additional information on the management of amendments can be found in the IRAS guidance. User Feedback The Health Research Authority is continually striving to provide a high quality service to all applicants and sponsors. You are invited to give your view of the service you have received and the application procedure. If you wish to make your views known please use the feedback form available on the HRA website: http://www.hra.nhs.uk/about-the-hra/governance/quality-assurance/. Please do not hesitate to contact me if you require further information. Kind regards Mrs Alka Bhayani Amendments Coordinator Health Research Authority Ground Floor | Skipton House | 80 London Road | London | SE1 6LH E.hra.amendments@nhs.net W. www.hra.nhs.uk Sign up to receive our newsletter HRA Latest. ----- End forwarded message ----- -- OPTIMISE II Trial Team Critical Care Research Office Adult Critical Care Unit The Royal London Hospital London United Kingdom E11BB Telephone: +44 (0)20 3594 0352 http://optimiseii.org