trials of Investigational Medicinal Products and High Risk Interventional Studies

Transcription

1 Standard Operating Procedure: Applying for Sponsorship for clinical trials of Investigational Medicinal Products and High Risk Interventional Studies SOP Number: UoA-NHSG-SOP-004 Version No: 2 Author: Date: 27 th March 2015 (Patricia Burns, Research Governance Manager, University of Aberdeen) Approved by: Date: 27 th March 2015 (Professor Julie Brittenden, R&D Director, NHS Grampian) Approved by: Date: 27 th March 2015 (Prof David Reid, Head of School of Medicine & Dentistry, University of Aberdeen) Issue Date: Date Effective: Review Due Date: Version No. Description of Changes Date Approved 1 New Document Change of title to better reflect content. Updated in line with current practice. Updated to include requirement for monitoring plan 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 Co-Sponsorship and Insurance Cover for Clinical Trials of Investigational Medicinal Products and High Risk Interventional Studies, from NHS Grampian (NHSG) and the University of Aberdeen (UoA). 2.1 This document applies to all researchers requesting sponsorship for a clinical trial of investigational product and/or High Risk Interventional Trials involving human participants, following successful grant application. UoA-NHSG SOPs may also be used by staff from other NHS areas, or organisations, with prior agreement. 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 3. REFERENCES Scottish Executive Health Department Research Governance Framework for Health and Community Care 2nd Edition (2006) UK Medicines for Human Use (Clinical Trials) Regulations 2004 Health Research Authority website Medicine and Healthcare Products Regulatory Agency website (MHRA) It is assumed that by referencing the principle regulations, all subsequent amendments made to the principle regulations are included in this citation. 4 ABBREVIATIONS AND DEFINITIONS BDT CI CSOG CTIMP IRAS MHRA MP PI R&D R&I REC RGF RGM SSI Business Development Team Chief Investigator Clinical Studies Oversight Group Clinical Trial of an Investigational Medicinal Product Integrated Research Application System Medicines and Healthcare products Regulatory Agency Medicinal Product Principal Investigator Research & Development Research and Innovation Research Ethics Committee Research Governance Framework Research Governance Manager Site Specific Information Page 2 of 5

3 5 RESPONSIBILITIES It is the responsibility of the Research Governance Manager to review the protocol and all relevant study documentation to assist the clinical studies oversight group in the decision on acceptance of sponsorship. It is the responsibility of the Research Governance Manager 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 or delegate to liaise with the Research Governance Manager prior to submission to REC, R&D and MHRA. It is the responsibility of the Clinical Studies Oversight Group (CSOG) to risk assess all CTIMPs and High Risk trials APPLYING FOR SPONSORSHIP Sponsorship Approval shall be obtained before application to REC, R&D and the MHRA. The CI/Delegate shall make the Research Governance Manager (RGM) aware of a planned CTIMP or High Risk Interventional Trial as early as possible. All documents sent to RGM shall be version controlled until sponsorship is confirmed. 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 Chief Investigator 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 as applicable, Evidence of involvement of Clinical Trial Pharmacy, 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. On receipt of the complete set of required documents, the Research Governance Page 3 of 5

4 Manager will 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 will be reviewed by Research Governance and identification made as to the whether the proposed research falls under MHRA clinical trial legislation. An assessment will be made of insurance requirements. The Research Governance Manager 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 will refer the study to the UoA insurer to confirm insurance cover. If UoA cannot obtain insurance for the trial, the Research Governance Manager will inform the Chief Investigator. R&I shall be contacted in regard to any required contracts and agreements. Research Governance will 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 will be provisionally graded according to MHRA guidelines. The study will be referred to the CSOG for a full risk assessment, confirmation or change of MHRA classification and Sponsorship approval. CSOG will liaise with the Research Governance Manager regarding any comments or queries concerning the trial and these will 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 will confirm or decline sponsorship. The Investigator can appeal the decision through CSOG. 6.3 CONFIRMATION OF SPONSORSHIP ARRANGEMENTS Following confirmation from CSOG that NHSG and UoA will co-sponsor the study, the Research Governance Manager will inform the investigator, sign the relevant IRAS forms and permission will be given to apply for CTA from MHRA. Page 4 of 5

5 The Research Governance Manager shall liaise with the Business Development Officers in R&I and NHSG R&D to complete a Co-Sponsorship Agreement detailing the delegated tasks that CI must follow to continue sponsorship and insurance. The Co-sponsorship agreement shall be signed by the Chief Investigator and Cosponsors to confirm the delegation of responsibilities between Co-Sponsors and the Chief Investigator. A risk based monitoring plan shall be prepared, in liaison with the Quality Assurance Manager, to over-see study related activities, ensure the continuing safety of trial participants and ensure compliance with the agreed protocol and the principles of GCP. 6.4 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 Research Governance Manager for review, classification and approval prior to submission to an NHS REC, R&D or the MHRA if required. The Research Governance Manager may refer the study back to CSOG for risk assessment and review of sponsorship 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