SOP 9- Training Record - United Lincolnshire Hospitals NHS Trust

Training and completion/maintenance of training recordsfor staff involved in Clinical Research at UnitedLincolnshire Hospitals NHS TrustSOP TitleTraining RecordSOP No. SOP 9AuthorConsulted DepartmentsLead ManagerSignature on FileJulia Farmery; Updated by HelenAyreLincolnshire Clinical ResearchFacility,Research and Development,Trust Consultants and researchstaff.Dr. Tanweer AhmedDirector of LCRF andResearch and DevelopmentManagerDate published 27/03/2014Review date of SOP 27/03/2016Version 2

Tracked Changes to SOP 9 - Training and completion/maintenance oftraining records for staff involved in Clinical Research at UnitedLincolnshire Hospitals NHS Trust (From Version 1.0 to Version 2.0)ParagraphTitleChangesTitle amended to state ‘Clinical Research’ rather than‘trials’ to more accurately reflect activity of researchactivity at ULHT1 - Purpose Amended to clarify purpose of SOP in terms of staff type(i.e. LCRF staff / Sponsored study research staff) and toinclude mandatory training requirements2 - Applies to Amended for clarification. Inclusion of relevant guidanceto support application of guidance to research staff.3 – RelevantSOPDocumentationAddition of “All LCRF SOP’s” as researchers are requiredto include evidence of having read and understoodrelevant SOP’s within their training records4 – Definitions Amended to include additional abbreviations used inupdated version5 – Policy Amended to include Research Governance Framework forHealth and Social Care, 2nd Edition (Department ofHealth, 2005); E6 Guideline for Good Clinical Practice andULHT Trust Training Policy6 - Procedure Section rewritten – please note significant changes fromprevious version7 - References No change8. Appendices Addition of Appendix 1 to outline mandatory trainingrequirements for LCRF staff

1. Purpose:1.1 This document describes the procedure for establishing and maintainingtraining records for all staff involved in clinical research at ULHT in order todemonstrate compliance with training requirements such as those of theTrust and as outlined in the Research Governance Framework for Healthand Social Care, 2 nd Edition (DOH, 2005) and ICH GCP.1.2 All staff involved in the conduct of clinical research that is sponsored, cosponsoredor hosted by ULHT, will maintain up to date training records toensure that all staff allocated duties within clinical research are qualified byeducation, training and experience to perform their delegated tasks.1.3 Additionally the mandatory training requirements of individuals employedwithin ULHT LCRF / R&D will also be outlined to ensure compliance ofdepartmental staff with Trust employee training policy.2. Applies to:2.1 All staff who participate in both hosted and sponsored clinical research atULHT including Chief Investigators (CI’s), Principal Investigators (PI’S), Co-Investigators, research nurses etc.2.2 All staff employed within LCRF and/or R&D2.3 “Everyone involved in research with human participants, their organs,tissue or data is responsible for knowing and following the law and theprinciples of good practice…set out in [the Research Governance Frameworkfor Health and Social Care (2005). They] must be aware of, and have readyaccess to, sources of information and support in undertaking that role.”(Department of Health, 2005)2.4 In the case of CTIMP’s investigators should be aware of and complywith GCP and the applicable regulatory requirements (ICH GCP 4.1.3).2.5 “For research, training should be appropriate and proportionate to the typeof research undertaken, and should cover the responsibilities of researchersset out in relevant legislation and standards. There is no set requirement forthe frequency of such training. Researchers are expected to maintainawareness of current standards through reference to published guidance andrelevant policies. Training should be updated when legislation has changed,new policies or practice have been implemented, different research activitiesare to be undertaken, or a significant period of time has elapsed sinceresearch activities have been conducted.For research involving CTIMPs, there is a requirement for GCP training.However, the timing of this training is not specified in legislation or guidancebut should be appropriate and proportionate. See the MHRA website forfurther details.” (Health Research Authority, July 2013)

2.6 In view of the above guidance, balanced with a requirement to maintainimpartiality, standardisation and oversight, the United Lincolnshire HospitalsNHS Trust recommends that all researchers should complete GCP trainingbefore starting research activity and update GCP every two years in case ofCTIMP trials and every three years for non-CTIMP studies.3. Relevant SOP documentation:United Lincolnshire Hospitals NHS Trust – Training Sitehttp://intranet/subsites/training_portal/All LCRF SOP’s available at:http://www.ulh.nhs.uk/for_staff/lincolnshire_crf/sop.asp4. Definitions:CTIMP - Clinical Trial of Investigational Medicinal ProductCI - Chief InvestigatorGCP - Good Clinical PracticePI - Principal InvestigatorLCRF – Lincolnshire Clinical Research FacilityULHT – United Lincolnshire Hospitals NHS TrustR&D – Research and DevelopmentRGF –Research Governance Framework for Health and Social Care, 2ndEdition (Department of Health, 2005)5. Policy:Research Governance Framework for Health and Social Care, 2 nd(Department of Health, 2005)EditionE6 Guideline for Good Clinical PracticeULHT Trust Training Policy6. Procedure:6.1 A training record must be kept for each individual involved in clinicalresearch at ULHT in order to demonstrate that they are appropriately qualifiedby education, training and experience, for the role they play in relation to any

esearch activity, in accordance with their duty as stipulated in the RGF, 2005and in the case of clinical trials, ICH GCP 4.1.1.6.2 As a minimum this record should comprise of: a short, current (dated within the last 2 years) signed CV and evidence of GCP training (copies filed in all related study site filesand saved in shared folder) any other mandatory training requirements stipulated by theResearch Sponsor of the study on which the individual is working(to be filed in the study Site File). a signed record of having read and understood all relevant LCRFR&D SOP’sN.B In the case of hosted studies, the original SOP training log should beforwarded to the Research Governance Manager and filed within the SOPmaster file (It is not required that copies are filed in individual site files); in thecase of ULHT Sponsored studies the original shall remain in the Trial MasterFile and a copy should be forwarded to the Research Governance Manager.6.3 In addition it is strongly recommended that all staff involved in clinicalresearch within ULHT, undertake the following two e-learning modules on a 2yearly basis (copy of certificates to be forwarded to the Research GovernanceManager) particularly those employed within LCRF or undertaking the role ofChief or Principal Investigator:Available at:- Research Data and Confidentiality and;- Research and Human Tissue Legislationhttp://www.byglearning.co.uk/mrcrsc-lms/course/category.php?id=16.4 If not located within the site file, the location of training records must bemade clear and be available for inspection as required by regulatory and otherrelevant authorities. However researchers must ensure that a complete recordis archived on study completion.6.5 It is the responsibility of the CI/PI to ensure that all staff allocatedduties on the Delegation of Responsibility Log are suitably trained in activitieslinked to those duties.6.6 Staff should be conversant with changes to legislation that require GCPor other staff training to be updated. It is expected that GCP training will berenewed every two years (three in the case of non-CTIMP activity).6.7 No member of staff is to be allowed to conduct trial visits or clinical trialparticipant appointments without appropriate training. The CI/PI and otherappropriate departmental staff can initially arrange training on trial specificprocedures but staff are encouraged to be proactive with regard to their own

training. The study Sponsor has the final decision regarding mandatorytraining requirements.6.8 In order to fulfil Trust Mandatory training requirements all staffemployed within ULHT LCRF / R&D should also undertake and maintainevidence within their personal training record of having undertaken relevanttraining commensurate with their position, and as outlined in the Appendix 17. Responsibilities7.1 The CI and in the case of hosted studies PI, is responsible forensuring that each member of the research team is qualified by education,training and experience to discharge his/her role in the study, and theirqualifications are documented.” (RGF 3.6.3)7.2 Training Records must be reviewed regularly by team leaders andindividual staff to identify gaps. If a member of staff feels that he or sherequires extra training on procedures, arrangements should be made toprovide this training. Refresher courses are to be arranged on procedureswhere expertise may have lapsed.7.3 ULHT Sponsored Studies - Chief Investigators are responsible forensuring that themselves and individuals to whom responsibilities have beendelegated within their study, including at additional sites, are appropriatelyqualified by education, training and experience. This should be demonstratedby a current signed CV, as a minimum dated within the last 2 years, evidenceof GCP training (in accordance with ULHT R&D guidance) and training onrelevant SOP’s as directed by the Research Governance Manager.7.4 On permanently leaving ULH employment, staff members may taketheir training records with them. However, a full copy must be retained alongwith other trial documentation until the trial’s documented archiving period hasexpired.8. References:Many thanks are given to Maria Koufali, Assistant Director of Research &Innovation for the adoption of some parts of Nottingham University Hospitals,Training Record, SOP 19.

APPENDIX 1 –Lincolnshire Clinical Research Facility / R&D CLINICAL STAFF –Mandatory Training RequirementsCourse How often Method NotesHarassment and Once on E-learning AllbullyinginductionCustomer Service Once on Induction AllinductionManagement of Once on Induction Allviolence andaggressioninductionEquality and Annual e-learning or All StaffDiversitySafeguardingChildren and youngpeopleSafeguarding AdultsResuscitationtrainingInformationGovernanceLevel 1 yearlyLevel 23-yearlyAgree withmanager re:required levelLevel 1 yearlyLevel 2 3-yearlyAgree withmanager re:required levelAnnual – seeResuscitationservice’swebsite formore detailsAnnualrefresher, (Fullcourse 3classroomClassroom ore-learningClassroom ore-learninge-learning plusassessmente-learningyearly)Fire Training Annual E-learning/Classroomalternate yearsInfection Control Annual Classroom ore-learningBlood Transfusion 2 yearly e-learning;classroom atleast 4 yearly.Plusassessmentwill be requiredGCP 2 yearly Classroom ore-learningResearch andHuman TissueLegislationLevel 1 – ALL STAFFLevel 2 -All staff who have regularworkplace contact with children,young people and familiesLevel 1 – All staffLevel 2 - All staff who have regularworkplace contact with vulnerableadults and familiesBasic Life support – All clinicalstaffAll staffAll staffAll staffAll clinical staff in accordance withULHT mandatory trainingrequirementsAll Research staff. 2 yearly ifinvolved in CTIMP’s, 3 yearly innon-CTIMP.2 yearly e-learning http://www.byglearning.co.uk/mrcrsc-lms/course/category.php?id=1Research Data and 2 Yearly e-learning http://www.byglearning.co.uk/mrcr

ConfidentialityHealth RecordKeepingCompliance Trainingfor shipping Class6.2 DangerousGoodsHealth and safety(including COSHH,slips trips and falls)VenousThromboembolismMoving andHandlingIntroduction toInformed Consent inClinical ResearchRisk ManagementAwarenessMedicinesManagementConflict resolutiontrainingsc-lms/course/category.php?id=12 yearly e-learning All staff2 yearly e-learning All staff involved in handling,packaging and transportingdangerous goods3 yearly Classroom ore-learningAll staff3 yearly e-learning Staff working with patients at riskof VTE3 yearly e-learning All Staff – level dependent on typeof M&H in role – now 3 yearly3 yearly Classroom or All staff involved with obtaininge-learning consent in clinical research.3 yearly e-learning All staff3 yearly E-learning + Clinical research staff as outlinedassessment in SOP163 yearly Classroom AllLincolnshire Clinical Research Facility / R&D Non-Clinical Staff –Mandatory Training RequirementsCourse How often Method NotesHarassment and Once on E-learningbullyinginductionCustomer Service Once on InductioninductionManagement ofviolence andaggressionOnce oninductionInductionHealth RecordKeepingOnce oninduction forstaff who donot havecontact withhealth records;otherwise 2yearlyInduction ; e-learningEquality andDiversityAnnual Classroom ore-learningSafeguardingChildren – Level 1Annual Classroom ore-learningSafeguarding Adults Annual Classroom ore-learningInformationGovernancee-learningAnnualrefresher, (Fullcourse 3

yearly)Fire Training Annual E-learning/Classroomalternate yearsInfection Control Annual Classroom ore-learningGCP 2 yearly Classroom ore-learningResearch andHuman TissueLegislationResearch Data andConfidentialityRisk ManagementAwarenessConflict resolutiontrainingHealth and safetyand welfare(including COSHH,slips trips and falls)Moving andHandling –inanimate loadsAll Research staff. 2 yearly ifinvolved in CTIMP’s, 3 yearly innon-CTIMP.2 yearly e-learning http://www.byglearning.co.uk/mrcrsc-lms/course/category.php?id=12 Yearly e-learning http://www.byglearning.co.uk/mrcrsc-lms/course/category.php?id=13 yearly Classroom ore-learning3 yearly Classroom All3 yearly Classroom ore-learning3 yearly Classroom ore-learningAll staffAdditional Mandatory Training for Managers (Band 7 – 9)Course How often Method NotesInvestigation of OnceFace-to-faceIncidents,complaints andclaimsProactive RiskManagement3 yearly Face-to-faceThis SOP will be reviewed every two years, a more updated revision ofthe SOP will be implemented if new local, national or internationalregulations change. This would therefore replace the existing document.All SOPs can be located on the Research and Development’s shared fileand a hard copy of all SOPs are kept in the SOP Master File