NIHR CSP Guide for Researchers New UK process for handling amendments to NIHR CSP studies A revised UK study amendment handling process is being introduced across the UK in November 2014. The purpose is to reduce the number of study amendments that NHS organisations need to review for continuing NHS Permission, thereby speeding up the timelines of amendments that do need review. The process is recommended to run in parallel to regulatory review and harmonises across all four UK nations, the principle of a 35 calendar day default approval of amendments for NHS organisations and introduces the categorisation of amendments into Category A, B, or C. The new process will benefit both researchers and NHS organisations by reducing overprocessing and minimising unnecessary delays to the implementation of Category C amendments. CATEGORY A CATEGORY B CATEGORY C • An amendment that impacts or affects ALL participating NHS organisations, therefore needs to be considered and may need change control actions • An amendment that impacts or affects SPECIFIC participating NHS organisations. Only at these organisations does it need to be considered and take any change control actions required • An amendment that has no impact on NHS organisations hence does not require management or oversight. R&D do not need to be notified of such amendments, however will have access to all documents within their CSP Module.  Subject to regulatory approval, Category C amendments can be implemented immediately. For Category A and B amendments, NHS Organisations have a maximum of 35 days to raise an objection otherwise the amendment can be implemented at the end of the 35 day period. They are encouraged to implement earlier where possible. What must I do?  Amendments should be submitted to CSP electronically through IRAS for England-led studies. We strongly recommend that this happens in parallel to the applications to other regulators.  Where the study is led by another Devolved Administration, the amendment should be sent to the Lead Nation contact who will liaise with England. The Sponsor/CI is responsible for providing details of the amendment, including copies of revised documents, to all participating Investigators and study teams. What happens once I submit my application? Key principles The Lead Local Clinical Research Network  Applies to both substantial and nonsubstantial amendments1 as categorised by the Sponsor. (LCRN) will confirm:  Studies must have gained approval through CSP.  The 35 day period starts on receipt of a full amendment submission (i.e. amendment form, letter and revised documents).  Where required, regulatory approval must be in place before an amendment can be implemented. The only exception to this rule is an urgent safety measure. 1 As defined by REC, examples of substantial and nonsubstantial amendments can be found on the HRA website. November, 2014    whether the submission is complete whether the amendment is Category A, Category B or Category C the implementation date. Details of the amendment will be available to the participating R&D offices through CSP, where necessary for impact review and contract revision as required (agreement of which should not delay implementation). Your Lead LCRN (see website) can offer advice on preparing and submitting amendments. Further guidance is also available from NIHR CRN or specifically for commercial companies via our ‘Support My Study’ service. Submitting your amendment in IRAS 1. Amendments must be submitted electronically through IRAS. 2. To submit an amendment to CSP, go to the checklist tab on the R&D form. 3. Amendment documents should be attached to the relevant rows of the IRAS checklist. You must ensure the correct document categories are selected. For substantial amendments  You must attach both the signed PDF and XML version of the Notice of Substantial Amendment Form. For non-substantial  Attach PDF under the non-substantial amendment category. Other supporting documents  Attach to the checklist specifying the correct document category. 4. Regulatory approvals should be uploaded to the checklist and submitted as and when these are received. 5. To submit the amendment to CSP (including regulatory approvals once received) go to the e-submission tab on the R&D form. 6. Select your Lead LCRN from the drop-down list. 7. The submission can be made as either a ‘document only submission’ (NB, this will not include the revised application form) or an ‘R&D application e-submission’ (i.e. includes both the revised application form and documents added to the checklist)’. Changes to the SSI form and/or local supporting documents must be submitted through the SSI submission tab. You don’t need to update the IRAS data set every time. On some occasions, in addition to submitting the amendment form/letter and supporting documents, it will be necessary to submit a revised application form, please use the table of examples below as a guide. Revised R&D submission with signatures needed Revised R&D submission needed without signatures Revised SSI submission with signatures needed Document only submission • If the amendment alters the IRAS project filter settings enabling additional sections of the form (e.g. use of ionising radiation and/or collection or storage of tissue where previously there was none). • To add a new site to Part C, you will need to submit the revised form as part of your amendment, but there is no need to have the form re-signed. • If the PI changes and the original SSI form required an electronic authorisation or signature. • Change relates to the content of supporting documents only. • Providing copies of regulatory approvals received after submission of the amendment.