If you experience any technical problems in using the Tool, please contact amendments@hra.nhs.uk for support. You will be presented with a short series of YES or NOquestions. into an Individual Retirement Account (IRA). Organisations should do this in accordance with the new process in good time. The UCLH/UCL Joint Research Office has been one of the organisations in the country to test it for nearly 8 months. Give to IRA Owners A copy of the amendment and a cover letter explaining the changes is mailed to each IRA owner’s last known address. If a participating NHS/HSC organisation declines the amendment, you should discuss with that organisation and take appropriate actions in agreement with the NHS/HSC organisation. You should therefore contact the REC that originally issued favourable opinion for the study, flagging in your covering email that the amendment involves adding the involvement of adults lacking capacity. Back to the top. If you are notified that a participating organisation needs more time to assess the amendment you should not implement until they are ready to do so. Please ensure that the amendment tool is completed correctly before locking it for submission. If after this you have any difficulty creating an account, please contact the Technical Helpdesk for support on: helpdesk@myresearchproject.org.uk. Back to the top, For guidance on managing amendments to research conducted in the NHS/HSC please refer to the guidance here. Further ethical review is required for any substantial amendment made once the study has started. This is created from the Amendment tab associated with the RTB/RDB form. The Amendment Tool works on both Windows PC and Mac operating systems. When complete, click ‘Lock for submission’ which will generate a locked pdf copy of the completed Annex 2 form. The Annex 2 form will need to be signed. No. For queries on how to complete the Amendment Tool or questions on the results from it, once complete, support can be accessed as follows. by Analise French - Wednesday, 20 May 2020, 10:43 AM. REC email addresses can be looked up on the HRA website. On 2 June 2020 changes were introduced to the way amendments are notified to Research Ethics Committees and NHS/HSC, Notifying Amendments to projects with NHS REC review and/or HRA and HCRW Approval / NHS/HSC R&D permissions. replaced by the Amendment Tool. Urgent Safety Measures. Who should use the Non-Filers: Enter Payment Info Here tool? The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. The Inland Revenue Authority of Singapore (IRAS) is the largest revenue agency in Singapore responsible for the administration of taxes. The quality or safety of any investigational medicinal product used in the study Referring to this will help you select the correct type/s of change. I can confirm that this is a valid notice of a substantial amendment and will be reviewed by the Sub Committee at its next meeting. The online amendment submission functionality requires you to log in to the IRAS Identity Gateway, which is separate login to your main IRAS account. http://ec.europa.eu/health/documents/eudralex/vol-10/index_en.htm, https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues, https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device, Further guidance on how to use the online portal, Help - Maintaining your approvals - Amendments, IRAS Integrated Research Application System, version, Please refer to the Health Research Authority (HRA) website for, For guidance relating to clinical trials of investigational medicinal products (CTIMPs) and medical devices please refer to the, Project-based research (defined as any of the IRAS Project Filter question 2 categories except for RTBs and RDBs) should now prepare amendments using the, Amendments should be submitted for review via. Data controller (please note that an amended application form and supporting documents setting out the new data controller arrangements will be required, you are advised to contact the Confidentiality Advice Team prior to submission), Changes to the number of administrations of radioactive substances from Section A1 of the original Preliminary Research Assessment (PRA) form, Addition or removal of a procedure involving the administration of radioactive substances, Addition of a new study population with a different clinical condition (including changing the age of the participants), Addition of healthy volunteers receiving administrations of radioactive substances, Changes to the radiation risk information in the participant information sheet (PIS) following changes to the protocol, Create an Amendment to Research Application on the. Different review bodies have different requirements. Some of these questions require you to enter information exactly as it appears on the Amendment Tool (or amendment form in the case of RTB/RDB projects), so have this available to refer to. The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS. In doing so, you should include the NHS R&D Office, LCRN (where applicable) as well as the local research team. You should work with the organisation to resolve any outstanding issues. IRAS project ID* (or REC reference if no IRAS project ID is available): ... will generate a PDF copy of the completed amendment tool that can be included in the amendment submission. Non-substantial amendments for RTB and RDB projects do not need to be notified to the REC. Any undeliverable amendments that are returned are retained in the IRA owner’s file. IMPORTANT: The guidance provided on this page applies only to research projects with NHS/HSC R&D Permission or HRA and HCRW Approval. For England and Wales led studies: amendments@hra.nhs.uk, For Scotland led studies: Gram.nrspcc@nhs.scot, For Northern Ireland led studies: Research.Amendments@hscni.net, The Amendment Tool is being rolled out as part of a new process for processing amendments across the UK. You can access the amendment tool on IRAS. The completed Notice of Substantial Amendment form should be electronically authorised by all parties listed on the form’s authorisations tab in IRAS. Find out more at https://www.iras.gov.sg/irashome/e-Services/Other-Taxes/CorpPass/. shall use the IRAS Amendment Tool (substantial and non-substantial) and be submitted online once approved by RGT. Notifying substantial amendments Guidance available on the IRAS portal and two instructional videos to help you through the new process: will generate a PDF copy of the completed amendment tool that can be included in the amendment submission. You can then upload all documentation relating to your amendment and proceed to submit. guidance about Research Ethics Committees (REC) and NHS/HSC arrangements, Medicines and Healthcare products Regulatory Agency (MHRA) website, Notifying amendments to the Research Ethics Committee, Notifying amendments to NHS/HSC R&D offices, Notifying amendments to the Confidentiality Advisory Group (CAG), Notifying amendments to Her Majesty's Prison and Probation Service (HMPPS), Submission of amendments to Research Ethics Committees (RECs) and NHS/HSC on or after 2nd June 2020, Notifying Amendments to project-based research with NHS REC review and/or HRA and HCRW Approval / NHS/HSC R&D permissions. This can be done by either adding in an image of the signature to the excel form prior to locking the form, or you can print, sign and scan the pdf. Keep Copies A copy of the amen… You should list the names of the new sites in the description of amendment box in the Amendment Tool. Corppass is a corporate digital identity for businesses. Please flag in the email subject that your query relates to an amendment and include the project IRAS ID so that it can be identified and handled efficiently. IMPORTANT: For multicentre studies there is no need for you to send the amendment to R&D offices of participating organisations in these nations as the National Coordinating Function will pass this on to them along with any amended documents on your behalf. Because of the specific REC review requirements, it is not possible for this type of amendment to use online submission. A favourable opinion must be The HRA will also roll out a new amendment tool at the same time, which will simplify the amendment process by producing tailored guidance for researchers on where to submit their amendment and what actions they need to take. The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS. The Tool contains a ‘glossary of amendment options’ tab which details and provides guidance on all of the types of change available. Further information can be found in the IRAS help pages. Online submission of amendments and a new amendment tool will go live across the UK on Tuesday 2 June 2020. A brief training video introducing the online amendment submission functionality can be accessed on youtube. Details on how to submit amendments to MHRA (Medicines) are found below. The following template emails can be used to notify participating NHS organisations in England and Wales of an amendment: • Template email for sponsors to share category A or B amendment documents with sites (regulatory approvals outstanding)• Template email for Category A or B amendment documents with sites – where regulatory approvals in place• Template email for sponsors to share category C amendment documents with sites• Template email for sponsors to confirm implementation of an amendment. 2. We are a partner of the community in nation-building and inclusive growth. The tool will detect a Mac Operating System and provide specific instructions when you lock the tool. Guidance on notifying amendments to project-based research can be found here. Electronic filing of amended returns is available as of August 2020 through available tax software products. Please ensure that the amendment tool is completed correctly before locking it for submission. The Amendment Tool contains a ‘glossary of amendment options’ tab which details and provides guidance on all of the types of change available. The tool replaces the Substantial Amendment Notification Form, and Non-Substantial Amendment forms for non CTIMPs. The functionality for creating a pdf is different on Mac computers. The ‘Lock for submission’ button will turn green when this is completed. This is available under the ‘Annex 2’ tab of the Amendment Tool which is enabled only when the information entered into the amendment tool tab indicates that an Annex 2 notification is required. For staff working on HRA/IRAS projects: Amendment Tool and Guidance now available. Further guidance For any technical queries about accessing or using online amendment submission, contact: helpdesk@myresearchproject.org.uk. Lock for submission Declaration by the Sponsor or authorised delegate These should be sent to all participating organisations on receipt to ensure the participants' safety. A brief training video introducing the amendment tool and its functionality can be accessed on the HRA’s Learning Management System. When you have final copies of all supporting documentation in place, and have saved the pdf of the Amendment Tool, you should proceed to online submission. Back to the top. Any queries about the amendment itself for non-REC studies can access support as follows. After you have submitted your amendment, you should share your completed Amendment Tool with confirmation of amendment category and, if applicable, amended documents with relevant participating NHS organisations in England and/or Wales. It should then be submitted to the REC alongside all supporting documentation by email. obtained prior to implementing the amendment, unless it is an urgent safety measure. 4.0 03 July 2020 Please note: This is the favourable opinion of the REC only and does not allow the amendment to be implemented at NHS sites in England until The Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals for health and social / community care research in the UK. These should be sent to all participating organisations on receipt to ensure the participants' safety. You will need to register for an account in order to access the video, and we recommend that you click ‘Enrol’ before watching and click ‘Complete’ once finished to create a record of your learning. SOPs, guidance documents and templates etc.). Welcome. SOPs, guidance documents and templates etc.). The current version of the Amendment Tool is available here: NB: The Amendment Tool is an excel document which uses macros. 3. The aim of this decision tool is to help you decide whether or not your study is research as defined by the UK Policy Framework for Health and Social Care Research.
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