SOP Number: SOP-QA-4 Version No: 2. Author: Date: (Patricia Burns, Research Governance Manager, University of Aberdeen)

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1 Standard Operating Procedure: SOP Number: SOP-QA-4 Version No: 2 Author: Date: (Patricia Burns, Research Governance Manager, University of Aberdeen) Approved by: Date: (Professor Maggie Cruickshank, Interim R&D Director, NHS Grampian) Approved by: Date: (Professor Steve Heys, Head of School, University of Aberdeen) Issue Date: Date Effective: Review Due Date: Version Description of Changes Date Effective 1 2 Change of number for Q-Pulse Addition of Associated Documentation at 3 (Replaces UoA-NHSG-SOP-004 V2) Revised title Revised purpose/introduction at 1 Removal of use by other NHS areas at 2.3 Revision of associated documents at 3 Revised responsibilities at 5 Revised procedure at This SOP will be reviewed at least every 3 years from initial and subsequent issue dates. Page 1 of 5

2 1 PURPOSE/INTRODUCTION 2 SCOPE To describe the procedure for obtaining Sponsorship and Insurance Cover for clinical research, including Clinical Trials of Investigational Medicinal Products (CTIMPS) and High Risk Interventional Studies, from NHS Grampian (NHSG) and/or the University of Aberdeen (UoA) This document applies to all researchers requesting sponsorship for clinical research, including a CTIMP and/or High Risk Interventional Studies involving human participants, following successful grant application if applicable. The decision to grant sponsorship and Insurance cover is granted on a case by case basis and this SOP must be followed in each application. ASSOCIATED DOCUMENTS TMP-QA-7 Sponsor Registration Form 4 REFERENCES Scottish Executive Health Department Research Governance Framework for Health and Community Care 2 nd Edition (2006). UK Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031) as amended. Medicine and Healthcare products Regulatory Agency website (MHRA). Current versions of these documents can be accessed via the Clinical Research Governance and Quality Assurance Website: It is assumed that by referencing the principal regulations, all subsequent amendments made to the principal regulations are included in this citation. 4.1 ABBREVIATIONS AND DEFINITIONS CI CSOG CTIMP IRAS MHRA PI R&D R&I REC Chief Investigator Clinical Studies Oversight Group Clinical Trial of Investigational Medicinal Product Integrated Research Application System Medicines and Healthcare products Regulatory Agency Principal Investigator Research & Development Research and Innovation Research Ethics Committee RGM Research Governance Manager Page 2 of 5

3 5. RESPONSIBILITIES It is the responsibility of the Research Governance Manager (RGM), or delegate, to review the protocol and all relevant study documentation to assist in the decision on acceptance of sponsorship. It is the responsibility of the RGM, or delegate, and the Business Development Team in Research and Innovation (R&I) to liaise with the researcher to confirm indemnity provision for each trial. It is the responsibility of the Chief Investigator (CI) to liaise with the RGM, or delegate, prior to submission to REC, R&D and MHRA and to have received confirmation in principle of sponsorship prior to any application to REC, R&D or MHRA. It is the responsibility of the CI, or delegate, to make the RGM aware of a planned CTIMP or High Risk Interventional Study as early as possible. It is the responsibility of the Clinical Studies Oversight Group (CSOG) to risk assess all CTIMPs and High Risk Studies at the request of the RGM APPLYING FOR SPONSORSHIP All documents sent to RGM shall be draft versions. Documents shall be sent to researchgovernance@abdn.ac.uk Project registration form, Completed checklist, Draft protocol, Full IRAS dataset, Evidence of peer review relevant to the protocol and funding, Short CV of CI and any co-investigators, Evidence of current (within two years) GCP training for trial staff, Investigator Brochure, Summary of Product Characteristics or Investigational Medicinal Product Dossier if applicable, Evidence of involvement of Clinical Trial Pharmacy if applicable Copies of all documents relevant to participation: Advert; Participation Information Sheet; Letter of invite; Informed Consent Form; Patient diary; Questionnaires; Letter to GP; Draft s. Page 3 of 5

4 On receipt of the complete set of required documents, the RGM shall register the trial on the Sponsor database and notify the investigator of the unique identification number. 6.2 Risk Assessment All documents pertaining to the sponsorship application shall be reviewed by the Research Governance Team and identification made as to whether the proposed research falls under MHRA clinical trial legislation. An assessment will be made of insurance requirements. The RGM, or delegate, shall forward the protocol to R&I to advise if: a) UoA insurance is sufficient for the trial, b) If trial specific insurance must be obtained. R&I will advise on any costs that may be incurred for which funding must be in place. If the trial falls out with the terms of UoA clinical research policy, the business development team in R&I shall refer the study to the UoA insurer to confirm insurance cover. If UoA cannot obtain insurance for the trial, the RGM, or delegate, shall inform the CI. R&I shall be contacted in regard to any required contracts and agreements. The RGM, or delegate, shall provide advice and guidance on any amendments required prior to review by CSOG and liaise with the investigator to ensure study documents identify and mitigate potential risks to trial participants and to trial integrity. The study shall be provisionally graded, according to MHRA guidelines, when relevant. CTIMPs and high risk studies shall be referred to the CSOG for a full risk assessment, confirmation or change of MHRA classification and Sponsorship approval. CSOG shall liaise with the RGM, or delegate, regarding any comments or queries concerning the trial and these shall be directed to the investigator for clarification. Discussion on sponsorship for the study shall be recorded in the minutes, including the result of any decision. CSOG shall confirm or decline sponsorship. The Investigator can appeal a decision through CSOG. 6.3 CONFIRMATION OF SPONSORSHIP ARRANGEMENTS Following confirmation that NHSG and/or UoA shall sponsor the study, the RGM, or delegate, shall inform the investigator, sign the relevant IRAS forms and, for CTIMPs and device studies, permission shall be given to apply for CTA from MHRA. Page 4 of 5

5 The RGM shall liaise with the Business Development Officers in R&I and NHSG R&D to complete a Sponsorship Agreement where required, detailing the delegated tasks that the CI must follow to continue sponsorship and insurance. The Sponsorship agreement shall be signed by the CI and Co-sponsors to confirm the delegation of responsibilities between Sponsors and the CI. A risk based monitoring plan shall be prepared, in liaison with the Quality Assurance Manager (QAM), to oversee study related activities, ensure the continuing safety of trial participants and ensure compliance with the agreed protocol and the principles of GCP. 6.4 CTIMPS AND DEVICE STUDIES ONLY: Before submission to the MHRA a EudraCT (European Clinical Trials Database) number must be obtained. This is a unique reference number for each trial and must be included on the application to the MHRA. Go to and follow the on screen instructions. 6.5 APPLICATION TO MHRA FOR CLINICAL TRIALS AUTHORISATION: The MHRA do not accept submissions on physical media (CD/DVD/Letters); only submissions using the Common European Submission Platform (CESP) will be accepted. For further information visit the MHRA website For applying to REC for ethical opinion see SOP-QA AMENDMENTS The review of Sponsorship arrangements for all research projects is ongoing while the project is active. It is the CI s responsibility to forward details of all amendments to the RGM for review, classification and approval prior to submission to an NHS REC, R&D or the MHRA if required. The RGM may need to refer research projects back to CSOG for further risk assessment and review of sponsorship depending on the nature of the amendment. Page 5 of 5