SPONSORSHIP APPROVAL DOCUMENT NO.: GS003 v2.0 AUTHOR: Heather Charles ISSUE DATE: 05 AUG 2016 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint office comprising clinical research management staff from NHS Lothian (NHSL) and the University of Edinburgh (UoE). 1.2 The Medicines for Human Use (Clinical Trials) Regulations SI 2004/1031 (as amended), and the Research Governance Framework (Scotland 2006, 2 nd Edition) define the Sponsor as the individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a trial. 1.3 New research studies intended for Sponsorship by NHSL and/or UoE are reviewed to ensure that the design of the study meets appropriate standards and that all necessary arrangements are in place to ensure appropriate conduct and reporting. 2 PURPOSE 2.1 To document the procedure for obtaining Sponsorship approval in principle from NHSL and/or UoE. 3 SCOPE 3.1 This SOP applies to all researchers requesting Sponsorship approval for studies single-sponsored by NHSL or UoE, or for studies co-sponsored by NHSL and a third party organisation. This SOP applies to NHSL/UoE research governance staff involved with the oversight of studies. 4 RESPONSIBILITIES 4.1 It is the responsibility of the Investigator or designee to provide all necessary study information/documentation to ACCORD, including amended documents. 4.2 It is the responsibility of the ACCORD administration team or the Sponsorship reviewer to assign an ACCORD Sponsorship identifier, enter study details in the Sponsorship tracker, and send the Investigator the list of required documents. Page 1 of 6
4.3 It is the responsibility of the administration team to identify a Sponsorship reviewer if the study documentation comes to ACCORD via the ACCORD enquiries e-mail (enquiries@accord.scot). 4.4 It is the responsibility of the Sponsorship reviewer to review relevant documentation prior to Sponsorship approval and to re-appraise Sponsorship, where appropriate, for the duration of the trial. 5 PROCEDURE 5.1 Identification of New Studies 5.2 A new study can be identified by any member of staff by various means; however it is recommended that Investigators contact the ACCORD administration team directly in the first instance (enquiries@accord.scot). 5.3 Sponsorship Information 5.3.1 At initial contact, as a minimum, the Investigator or designee will provide the following information to the ACCORD office; Chief Investigator (CI) name, employment & contact details CI honorary contract status Working title of the study Estimated start date Multi-centre or single centre 5.3.2 If the enquiry is received by the administration team, they will Liaise with the Research Governance team to identify a named Sponsorship reviewer e.g. Clinical Research Facilitator, Research Governance Coordinator, Research Governance Manager or NHS Head of Research Governance. 5.3.3 Whoever takes receipt of the enquiry (e.g. admin. team or research governance) will; Assign an ACCORD Sponsorship identifier (internal use) to the study and record the available study details in the ACCORD Sponsorship study tracker. Provide the Investigator, or designee, with a list of documents, required for review; o Draft Protocol o o IRAS Forms (Full Data Set) Draft Consent Form and Participant Information Sheet, if applicable On receipt of a complete document set (where possible), pass all relevant information to the assigned Sponsorship reviewer (if applicable), at which point Sponsorship review is initiated. Page 2 of 6
5.4 Document & IRAS Review 5.4.1 The Sponsorship reviewer will; Consult with the Heads of Research Governance (NHSL and/or UoE), or designees, if confirmation that Sponsorship is required has not already been established. Classify the study as CTIMP/non-CTIMP (using the MHRA s online algorithm) or as a clinical investigation of a medical device or a non-regulated device trial. Use Sponsorship Checklist form (GS003-F01) and template Sponsorship Review (GS003-T01) for the purpose of documenting trial categorisation, checks and reviewer comments. 5.4.2 For studies which are single sponsored by the UoE and impact on NHSL services, the Sponsorship reviewer will identify any Service Support Costs and/or Excess Treatment Costs associated with the study. 5.5 Agreements and Indemnity 5.5.1 The Sponsorship reviewer will; Liaise with the contracts team to ensure agreements, where required, are prepared that reflect the agreed designation of responsibilities for the study. Ensure that the Sponsor has adequate indemnity arrangements in place for the study. 5.6 Risk Assessment 5.6.1 The Sponsorship reviewer will prompt the Quality Assurance (QA) Manager, or designee, to organise a combined risk assessment, where required, in accordance with SOP GS002 (Combined Risk Assessment). This will be done in parallel with Sponsorship review or at the earliest opportunity thereafter i.e. when study documents are at a sufficiently advanced stage. 5.7 Investigator Feedback 5.7.1 Once the initial review is complete, the Sponsorship reviewer will provide feedback to the Investigator or designee by e-mail, including completed template GS003-T01 (Sponsorship Review). 5.7.2 If any issues remain that could give the Sponsor s presentative cause to decline Sponsorship, they will be communicated to the Heads of Research Governance (NHSL and/or UoE) or Senior Management Team (SMT) for guidance. Page 3 of 6
5.8 Confirmation of Sponsorship 5.8.1 Criteria for a third party NHSL co-sponsoring partner to meet are listed in GS003-T02 (NHS Lothian Co-Sponsorship Criteria) and this document should be completed before an agreement is reached to co-sponsor CTIMPs. 5.8.2 Once the Investigator feedback process is concluded with all queries answered to the satisfaction of the Sponsorship reviewer, they will ensure form GS003-F01 (Sponsorship Checklist) and template GS003-T01 (Sponsorship Review) are finalised and signed, where appropriate. 5.8.3 The Sponsorship reviewer will advise the Investigator that they can request Sponsor s authorisation of the relevant IRAS forms (e.g. REC, R&D, MHRA) through IRAS. A Sponsorship letter will be drawn up and provided to the Investigators, if required. 5.8.4 Sponsorship review documentation will be saved electronically in the appropriate study specific Sponsorship Review folder, including a pdf of the authorised IRAS form(s). 5.8.5 A copy of this documentation will be retained in the Sponsor File. 5.8.6 The Sponsorship reviewer, or designee (e.g. administration staff), will update the Sponsorship tracker with any relevant study information and will continue to do so throughout the life of the study. 5.9 Continued Sponsorship Approval 5.9.1 The Investigator or designee will submit proposed amendments to the Sponsor for continued sponsorship approval and sign-off prior to submission to the REC, R&D or the MHRA, if required (CR007 Study Documents and Amendments). 5.9.2 The Sponsorship reviewer will classify amendments as non-substantial or substantial. 5.9.3 For all substantial amendments the Sponsorship reviewer will complete the Sponsorship Substantial Amendment Checklist (GS003-F02) based on the documents and information provided. 5.9.4 If additional information is required, the Sponsorship reviewer will liaise with the Investigator or designee. 5.9.5 The Sponsorship reviewer will provide the completed/signed checklist (GS003-F02) to the NHSL administration team who will process this as per SOP GS007 (R&D Review of Amendments). Page 4 of 6
5.9.6 If the Sponsorship reviewer indicates that sponsorship of the study can continue, they will inform the Investigator, or designee, of the amendment classification via email. The Investigator, or designee, may subsequently submit the amendment to the relevant bodies. 5.9.7 If the Sponsorship reviewer indicates that sponsorship of the study cannot continue in line with the proposed amendment, they will inform the Investigator, or designee, and ask them to reconsider the amendment. 5.9.8 Should the terms of any agreement with the Sponsor be breached or if the Sponsor does not receive copies of all amendments and approvals, Sponsorship can be suspended or withdrawn, and a letter to this effect sent to the Investigator. 6 REFERENCES AND RELATED DOCUMENTS GS003-F01 Sponsorship Checklist GS003-F02 Sponsorship Substantial Amendment Checklist GS003-T01 Sponsorship Review GS003-T02 NHS Lothian Co-Sponsorship Criteria POL002 Sponsorship Policy GS002 Combined Risk Assessment GS007 R&D Review of Amendments CR007 Study Documents and Amendments Medicines for Human Use (Clinical Trials) Regulations 2004, as amended Research Governance Framework for Health and Community Care (Scotland 2006 2 nd ed) MHRA s online algorithm: Is it a clinical trial of a medicinal product? https://www.gov.uk/government/uploads/system/uploads/attachment_data /file/317952/algothrim.pdf 7 DOCUMENT HISTORY Version Number Effective Date Reason for Change 1.0 14 DEC 2015 New SOP. 2.0 19 AUG 2016 Responsibilities section (4) and Sponsorship Information section (3) updated to reflect that enquires may come in to Research Governance as well as via the enquiries e-mail. Continued Sponsorship Approval section (5.9) encompasses GS001-W03. Page 5 of 6
8 APPROVALS Sign Date Signature kept on file AUTHOR: Heather Charles, QA Manager, NHS Lothian, ACCORD Signature kept on file APPROVED: Fiona McArdle, Deputy R&D Director, NHS Lothian, ACCORD Signature kept on file AUTHORISED: Lorn Mackenzie, QA Coordinator, NHS Lothian, ACCORD Page 6 of 6