Research & Development Quality Manual

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QM-1 V4Title: Research & Development Quality ManualEffective Date: 1-6-18Author: Richard Cowie, QA ManagerApprover: Prof Maggie Cruickshank, R&D DirectorReview Date: 1-6-21Version: 4Approver: Prof Steve Heys, Head of SchoolResearch & Development Quality ManualDocument HistoryVersionDescription of update1New document2Updated to reflect new SOP numbers in Q-Pulse3Reformatted and updated4Updated references to UK Policy Framework for Health & Social CareResearch and GDPR.Reference to Genetically Modified Micro organismsDate Effective29-5-152-10-151-4-171-6-18Uncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 1 of 19

1. Log of ge(s) changedVariousAll5-613 and 1469 and 1691012-1312 and 1416193, 9 and 123 and 91919Description of updateNew documentUpdated to reflect new SOP numbers in Q-PulseReformattedInclusion of ADE, SADE, USADE and AMP at 4Inclusion of ADE, SADE and USADEReference to Laboratory fileAddition of customer feedback at 5.3.4 & 6.5.6Addition of Data Protection Act 1998 at 5.4.3Reference to QMS Matrix at 6.1.2Reference to environmental procedures at 6.1.4Reference to Study Specific SOPsReference to corrections within CAPA at 6.5.3Reference to Biorepository and e-archiving 6.16Update reference to UK Policy Framework for Health &Social Care ResearchUpdate to include reference to GDPR andData Protection Act (2018)Reference to Genetically Modified Micro organisms at 6.14Change of third party archive details at 6.162. Index1.Log of updatesPage 22.IndexPage23.Outline of University of Aberdeen and NHS Grampian Page 34.GlossaryPage 5 - 65.Quality Management SystemPage 7 - 19Uncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 2 of 19

3. Outline of University of Aberdeen (UoA) and NHS Grampian (NHSG)The University of Aberdeen was founded in 1495 and is Scotland’s third oldest, and the UK’s fifth oldest,university. In 1497 it was the first university in the English speaking world to create a chair of medicine.The University of Aberdeen, which currently has 14,500 students, has invested heavily in medicalresearch in Aberdeen. Located on the Foresterhill Health Campus are the Institute of Medical Science,The Health Sciences Building, Suttie Centre for Teaching and Learning in Healthcare and The RowettInstitute of Nutrition and Health.NHS Grampian came into being in 2004 after the dissolution of two NHS Trusts. It is overseen by an NHSBoard responsible for improving the health of the Grampian population and for delivering thehealthcare required. The Board oversees the implementation of Scotland's national health agenda,tailored to the needs of the Grampian population of approximately 500,000 spread over 3,000 squaremiles. From April 2016 NHS Grampian’s fully integrated Health and Social Care Partnerships moved fromshadow form to full operation across the three Local Authority areas of Aberdeen City, Aberdeenshireand Moray. The main NHS Grampian site is the Foresterhill Health Campus; which is shared with theUniversity of Aberdeen. NHS Grampian works closely with the University of Aberdeen and RobertGordon University in delivery of medical research and training.This document sets out the Quality Management System for Clinical Trials of Investigational MedicinalProducts (CTIMPs) and Medical Device Clinical Investigations which are sponsored, or co-sponsored, by theUniversity of Aberdeen and/or NHS Grampian. The sponsorship function of the University of Aberdeen andNHS Grampian is undertaken by the joint NHS Grampian and University of Aberdeen Research &Development team, based at Foresterhill House Annexe, Foresterhill, Aberdeen; under the direction of theResearch & Development Director. The team consist of the Research and Development Director, SeniorResearch & Development Manager, Quality Assurance Manager, Research Governance Manager, NonCommercial Research Manager, Lead Research Nurse, Clinical Research Facilities Manager, ResearchGovernance Officer, Pharmacovigilance Monitor, Research Monitors, Quality Assurance Support Officer,Study Support Facilitator and administrative support. The team liaise with the Research & Innovation teamin the University of Aberdeen.The remit of the Research & Development team is to provide sponsorship, support and advice toresearchers engaged in clinical research and to ensure the implementation and maintenance of qualityassurance and research governance principles are applied to all projects, in accordance with the UK PolicyFramework for Health & Social Care Research, The Medicines for Human Use (Clinical Trials) Regulations2004 (SI 2004 No. 1031), as amended, the Principles of Good Clinical Practice (GCP), the General DataProtection Regulation (GDPR), Data Protection Act (2018) and the Human Tissue (Scotland) Act 2006.Uncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 3 of 19

3.1 Research Governance and Quality Assurance Aims To facilitate high quality clinical research for Clinical Trials of Investigational MedicinalProducts (CTIMPs) and Medical Device Clinical Investigations within the University ofAberdeen and NHS Grampian.To ensure the scientific integrity of clinical research and clinical trials within the University ofAberdeen and NHS Grampian.To ensure the rights, safety and well-being of all participants in clinical research and clinicaltrials within the University of Aberdeen and NHS Grampian.To ensure compliance with the Principles of Good Clinical Practice (GCP).To ensure compliance with the requirements of The Medicines for Human Use (Clinical Trials)Regulations 2004 (SI 2004 No. 1031) as amended.To facilitate the readiness of University of Aberdeen and NHS Grampian for inspection by theMedicine and Healthcare products Regulatory Authority (MHRA).Uncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 4 of 19

4. Glossary of HSGNRESNRSPIPISQAAdverse Device EffectAdverse Drug ReactionAdverse EventAuxiliary Medicinal ProductAdverse ReactionAnnual Progress ReportsAdministration of Radioactive Substances Advisory CommitteeCorrective Action and Preventive Action/Correction and CAPACentral Allocations SystemCo-ordinating CentreChief InvestigatorCase Report Form or Clinical Research FacilityContract Research OrganisationClinical Research Operational GroupClinical Studies Oversight GroupClinical Trials Facilitation GroupClinical Trial Application or Clinical Trial AuthorisationClinical Trial of Investigational Medicinal ProductClinical Trials UnitDevelopment International Birth DateData Monitoring CommitteeDevelopment Safety Update ReportEuropean Medicines AgencyEuropean Union drug regulating authorities Clinical Trials (EU Clinical Trials Database)Good Clinical Practice (ICH GCP – International Conference on Harmonisation)General Data Protection RegulationGood Laboratory PracticeGenetically Modified Micro organismsGood Manufacturing PracticeGene Therapy Advisory CommitteeHealth Research AuthorityHealth and Safety ExecutiveInvestigator BrochureInformed Consent FormInstitutional Review BoardInternational Organization for StandardizationInvestigational Medicinal ProductIntegrated Research Application SystemInvestigator Site File/Investigator Trial Master File*Medicines and Healthcare products Regulatory AgencyNHS GrampianNational Research Ethics ServiceNHS Research Scotland (NRSPermissionsCC – Permissions Coordinating Centre)Principal InvestigatorPatient Information SheetsQuality AssuranceUncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 5 of 19

mPC/SPCSOARSOPSSISUSARTMFTSCUSADEUKCRCUoAQuality Assurance ManagerQuality ControlQuality Management SystemQualified PersonRisk Assessment ProformaRandomised Controlled TrialResearch Ethics CommitteeProject Management CommitteeResearch & InnovationResearch Governance ManagerResearch Governance TeamReference Safety InformationSerious Adverse Device EffectSerious Adverse EventSerious Adverse ReactionStatistical Analysis PlanStatutory InstrumentSummary of Product CharacteristicsScottish On-line Appraisal ResourceStandard Operating ProcedureSite Specific InformationSuspected Unexpected Serious Adverse ReactionTrial/Project Master File*Trial/Project Steering CommitteeUnexpected Serious Adverse Device EffectUnited Kingdom Clinical Research CollaborationUniversity of Aberdeen* TMF – Documentation from a CTIMP or Medical Device Clinical Investigation must be filed in the TMF.This requirement is set down in both EU and UK legislation (2001/20/EC Article 15(5), SI 2004/1031 [asamended] 31A).The TMF forms the basis for an inspection to confirm compliance with regulatory requirements (Directive2005/28/EC Chapter 4, Article 16). The TMF is normally composed of a Sponsor TMF, held by the Sponsororganisation (or to whom this function is delegated), and an Investigator TMF, held by the investigator.These files together are regarded as comprising the entire TMF for the trial and should be established atthe beginning of the trial.In addition there may also be a Pharmacy file (held by the clinical trial pharmacy), R&D file (held by NHSR&D), Laboratory file held in the laboratory performing study analysis and Site file(s) where there ismore than one site.Uncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 6 of 19

5. Quality Management SystemGeneralUniversity of Aberdeen (UoA) and NHS Grampian (NHSG) have defined the quality framework for activitieswithin UoA and NHSG. A Quality Manual (QM), Quality Statement and Standard Operating Procedures(SOPs) are in place; together these form the Quality Management System (QMS). This covers planning,operation and effective controls within research activities carried out in UoA and NHSG. Records shall bemaintained by researchers to show evidence of compliance with the QMS and, where appropriate, theprinciples of GCP.5.1 Quality ManualThis Quality Manual is the statement by UoA-NHSG of its documented Quality Management System whichconforms with the principles of Good Clinical Practice (GCP) and The Medicines for Human Use (ClinicalTrials) Regulations 2004 Statutory Instrument No. 1031 (SI 2004/1031), as amended.Conformance with the requirements stated in the Quality Manual and in the UoA-NHSG StandardOperating Procedures is required for all UoA-NHSG staff engaged in CTIMPs and Medical Device ClinicalInvestigations. Where improved methods or procedures are identified, the documentation so affected shallbe officially and properly changed, when agreement has been reached between all Groups / Teamsinvolved (see SOP-QA-1 - Management of SOPs).This Quality Manual is a controlled document and is updated as required by the Quality Assurance Manager(QAM) and reviewed at least every three years.All staff shall be able to view the Quality Manual on the UoA-NHSG Clinical Research Governance & QualityAssurance website (www.abdn.ac.uk/clinicalresearchgovernance) and, where accessible, Q-Pulse*. Onlythe current version shall be displayed. Printed copies shall be regarded as uncontrolled when printed andcare should be taken to ensure that an out of date version is not being referred to.*NHS Grampian Research and Development Q-Pulse system.5.2 The Scope of the Quality Management System5.2.1 This Quality Manual applies to all researchers and Sponsor staff participating in CTIMPs andMedical Device Clinical Investigations which are sponsored, or co-sponsored, by University of Aberdeen(UoA) and/or NHS Grampian (NHSG).5.2.2 For research projects which are sponsored externally to the UoA or NHSG, local researchers andsupport staff shall refer to the respective Sponsor’s procedures and any timelines for handlingDeviations, Breaches and Urgent Safety Measures (for UoA-NHSG procedure see SOP-QA-25 –Deviations and Breaches).5.2.3 This Quality Manual demonstrates ‘good practice’ in all clinical research conducted in UoA andNHSG. The principles contained within it may be applied to work not listed in 5.2.1 to demonstrate andencourage a quality culture which is compliant with various quality assurance standards and regulations.5.2.4 This Quality Manual and UoA-NHSG SOPs may also be used by staff from other NHS areas, ororganisations, with prior agreement.Uncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 7 of 19

5.3 The interaction within the research project governance processes of the Quality ManagementSystem.Monitoring findings.Audit findings.MHRA findings.Feedback.Opportunities forImprovement.ImprovementLeadershipLeadership &commitment.Quality Statement.Quality Manual.Roles &responsibilities.ActPlanMonitoring.Audit.Internal QC.ManagementReview.EvaluationOperationalplanning andcontrol.CheckPlanningDoOperationSupportTargets &objectives.Riskassessment.Projectmeetings.GCP Training.QA awareness.Sponsor SOPs.Group/teamspecific SOPs &User Guides.Drop-in sessions.5.3.1 Like all Quality Management Systems the one operated by UoA-NHSG uses the ‘plan-do-check-act’principle of continual improvement. There is demonstrable management commitment with a QualityStatement, the Quality Manual (this document) and documented roles and responsibilities for key staff.5.3.2 Specific plans are formulated with targets, objectives and risk assessments performed. Plans, targetsand objectives are realised through training and awareness sessions, QA support, Research Governancesupport and the preparation of group and team specific SOPs and User Guides. SOPs and User Guides areimplemented and become operational.5.3.3 The processes and activities are checked for effectiveness through a programme of risk adaptedmonitoring and audit to identify opportunities for improvement. Corrections and Corrective and PreventiveActions (CAPA) are identified and agreed, leading to continual improvement of the QMS.Uncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 8 of 19

5.3.4 The Quality Management System is regularly reviewed (Management Review) for effectiveness andany improvements opportunities are identified. Stakeholder feedback is also sought to identify anyimprovement opportunities and is reviewed by senior management during the Management Review.The cycle then starts again.5.4 Quality Assurance5.4.1 UoA-NHSG is dedicated to delivering research that consistently satisfies its stakeholders. As anorganisation and as individuals, UoA-NHSG shall continuously strive to improve the quality of its activities.5.4.2 UoA-NHSG is committed to providing the highest possible quality of research to its collaborators,funders and customers; who include the NHS, pharmaceutical companies, Government Departments,Charities, Local Authorities within the UK and international bodies and organisations.5.4.3 UoA and NHSG are diverse organisations and no single quality assurance scheme covers all of theactivities of the organisations. As a result some of the different component sections within both UoA andNHSG have achieved and maintained accreditation and certification to a range of standards that meet theneeds and activities of the various parts of the organisations.The following list provides some details of the regulations and guidelines that UoA-NHSG currently complywith: UK Policy Framework for Health & Social Care Research.Principles of Good Clinical Practice (as outlined in Directive 2005/28/EC).UK Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004 No. 1031) as amended.General Data Protection Regulations (GDPR).Data Protection Act (2018).NHSG diagnostic laboratories are accredited by UKAS to ISO 15189:2012.UoA Rowett Institute of Nutrition and Health hold certification to ISO 9001:2015.NHSG Biorepository holds accreditation from Healthcare Improvement Scotland (HIS).The University of Aberdeen-NHSG Data Safe Haven (DaSH) is a Scottish Government accreditedSafe Haven.5.4.4 The University of Aberdeen has developed a Handbook for Research Ethics and Governance whichapplies to all academic disciplines. It is managed centrally and is the central authority and reference pointwithin the institution for matters relating to research governance which should be used and referred toaccordingly by research staff and students.5.4.5 Like all Higher Education Institutions (HEIs) in the UK, UoA maintains the academic standards ofqualifications and the quality of the student learning experience through a quality system that complieswith the Code of Practice for the Assurance of Academic Quality and Standards in Higher Education,published by the Quality Assurance Agency for Higher Education (QAA), an independent body establishedto provide public confidence in the quality and standards of higher education.6 Quality Management System Requirements6.1 OrganisationUncontrolled when printed.Please ensure that you are working on the most up to date version of this Quality Manual.QM-1 V4Research & Development Quality ManualPage 9 of 19

6.1.1 Management SystemThe UoA-NHSG Quality Management System covers clinical research work carried out in all parts of UoAand NHSG. Following the implementation of the Clinical Trials Directive 2001/20/EC, compliance withthe principles of GCP became a legal requirement throughout the EU for persons involved in ClinicalTrials of Investigational Medicinal Products (CTIMP). In the UK these requirements were achievedthrough The Medicines for Human Use (Clinical Trials) Regulations 2004, Statutory Instrument number1031 (SI 2004/1031), as amended.SI 2004/1031 sets out the processes for regulatory and ethical review of all interventional trials in orderfor them to gain Clinical Trial Authorisation (CTA) from the MHRA (the competent authority in the UK)and favourable Research Ethics Committee (REC) opinion. SI 2004/1031 provides the powers forinspection and enforcement by the MHRA.6.1.2 Management – staff & specific dutiesRecords of qualifications, training and experience of all staff shall be maintained by each member of staffinvolved in clinical research activities. This shall include, as a minimum, an up to date CV, a job description,evidence of appropriate training (eg GCP, QA, trial specific training) and an organisational chart.Before commencement of a clinical trial the Sponsor shall indicate which Sponsor SOPs should be read andunderstood by the CI (in addition to this Quality Manual) and recorded in their training file, or SOP sign-offsheet (TMP-QA-40). Similarly, in liaison with the Sponsor, the CI shall indicate which Sponsor SOPs and trialspecific SOPs (if applicable) each member of the study team should read and understand, and record intheir training file, or SOP sign-off sheet (TMP-QA-40). The Quality Management System Matrix (TMP-QA44) indicates the component parts of the QMS which the various research roles should be familiar with andmay be used in place of the SOP sign-off sheet.Within UoA-NHSG appropriate GCP training shall be in place before a CTIMP or Medical Device ClinicalInvestigation commences and shall be updated every two years.For specific projects a training matrix may be required to deta

Inclusion of ADE, SADE, USADE and AMP at 4 Inclusion of ADE, SADE and USADE Reference to Laboratory file Addition of customer feedback at 5.3.4 & 6.5.6 Addition of Data Protection Act 1998 at 5.4.3 Reference to QMS Matrix at 6.1.2 Reference to environmental procedures at 6.1.4 Reference to Study Specific SOPs Reference to corrections within CAPA at 6.5.3 Reference to Biorepository and e .

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