Mnitring and Audit f Clinical Research Studies Categry: Summary: Equality Analysis undertaken: Plicy Implementatin f this plicy will ensure that the Trust fulfils its statutry bligatins which in turn will maintain public cnfidence in the safety, rights and well-being f participants f research studies undertaken at the OUH Trust and that the reprted trial data are accurate, cmplete, and verifiable frm the surce dcuments. Sep 2015 Valid Frm: Jan 2016 Date f Next Review: Jan 2019 Apprval Date/ Via: Distributin: Related Dcuments: Authr(s): Further Infrmatin: This Dcument replaces: Medical Directr Trust Management Executive Via Research and Develpment t: Researchers within ORH Trust Research and Develpment Web Site Spnsrship f Clinical Research Studies Plicy Trust Management Apprval f Clinical Research Plicy Integrity in Research Plicy Research Prtcl Amendments Plicy Safety Reprting in Clinical Research Plicy Incident Reprting Plicy Fina Parker, Research and Develpment Manager Fina Parker, Fina.Parker@uh.nhs.uk Mnitring & Audit f Research Studies Plicy Versin 2.0 Lead Directr: Dr Tny Berendt Issue Date: 14 th January 2016 Page 1 f 9
Cntents Intrductin 3 Plicy Statement.. 3 Scpe.... 3 Aim. 3 Definitins.. 3 Respnsibilities. 5 Chief Executive. The Medical Directr / Directr f R&D / Research & Develpment Lead / Research and Develpment Manager.... Chief Investigatr (CI) / Principal Investigatr (PI)... Research and Develpment Staff.. Cntent f the Plicy 5 Training. 6 Mnitring cmpliance 6 Review f this plicy 7 References... 7 Equality Analysis.. 7 Dcument Histry 8 Appendices: 1 Equality Analysis... 8 Page Page 2 f 9
Intrductin 1. The Research Gvernance Framewrk fr Health and Scial Care (RGF) requires that, where an rganisatin is prviding care t research participants within studies with external Spnsrs, the rganisatin must ensure that legislatin related t research is fllwed. 2. The RGF requires that an rganisatin taking n the rle f Spnsr must cnfirm that there are prper arrangements in place t initiate, manage, mnitr and finance a study. 3. The Medicines fr Human Use (Clinical Trials) Regulatins 2004 require that rganisatins which take n the rle f Spnsr f clinical trials must have systems in place fr the management f that trial. 4. The bjective f mnitring, audit and cmpliance checks is t verify that: 4.1. The rights and well-being f the human subjects are prtected. 4.2. The reprted trial data are accurate, cmplete, and verifiable frm the surce dcuments. 4.3. The cnduct f the study is in cmpliance with the currently apprved prtcl; with Gd Clinical Practice (GCP); and in accrdance with the applicable lcal regulatry requirement(s). Plicy Statement 5. It is the plicy f the Oxfrd University Hspitals NHS Fundatin Trust ( the Trust ) t: Scpe 5.1. Prtect the safety, dignity, rights and well-being f all patients invlved in clinical research. 5.2. Ensure that arrangements are in place fr the management and mnitring f research studies, where the Trust has taken n the rle f Spnsr r Hst Institutin, including cmpliance with the relevant regulatins. 6. This Plicy applies t anyne cnducting research within the Trust, whether such research is spnsred r hsted by the Trust, including Clinical Trials f Investigatinal Medicinal Prducts (CTIMPs). 7. This dcument applies t all areas f the Trust, and all emplyees f the Trust, including individuals emplyed by a third party, by external cntractrs, as vluntary wrkers, as students, as lcums r as agency staff. Aim 8. This plicy sets ut a cnsistent prcedure fr versight f the prgress f clinical research studies and prmting quality and cmpliance with the relevant legislatin. Definitins 9. The terms in use in this dcument are defined as fllws: 9.1. Spnsr - The rganisatin taking respnsibility fr initiatin, management and financing (r arranging the financing) f a clinical trial r research study. 9.2. Hst Institutin The rganisatin where the clinical research will take place. Page 3 f 9
9.3. Mnitring - The act f verseeing the prgress f a clinical trial, and f ensuring that it is cnducted, recrded, and reprted in accrdance with the prtcl, Standard Operating Prcedures (SOPs), Gd Clinical Practice (GCP), and the applicable regulatry requirement(s). Mnitring is an nging activity, thrughut the cnduct f the trial. 9.4. Audit - A systematic and independent examinatin f trial related activities and dcuments t determine whether the trial related activities were cnducted, recrded and reprted accrding t the prtcl, the spnsr s SOPs, GCP and the applicable regulatry requirements. Audit is an assessment f cmpliance with these standards at a given mment in time. 9.5. Cmpliance Check A review f a specific aspect f a research study r a grup f studies, fr example: Cnsent r safety reprting. 9.6. Clinical Trial f Investigatinal Medicinal Prduct (CTIMP) - Any investigatin in human subjects, ther than a nn-interventinal trial*, intended: T discver r verify the clinical, pharmaclgical r ther pharmacdynamic effects f ne r mre medicinal prducts, T identify any adverse reactins t ne r mre medicinal prducts r T study the absrptin, distributin, metablism and excretin f ne r mre such prducts With the bject f ascertaining the safety r efficacy f thse prducts Such trials will be gverned by the Medicines fr Human Use (Clinical Trials) Regulatins 2004 and updates. * The Medicines and Healthcare prducts Regulatry Agency (MHRA) view a trial as interventinal where a drug is being given as an interventin and assessments are being undertaken t assess the effects. This is nt dependant n the prescriptin f that drug being undertaken as part f the prtcl. 9.7. Device Trial - A clinical investigatin designed t establish the perfrmance f a medical device which is intended t reveal adverse events under nrmal cnditins f use, and permit assessment f the acceptable risks having regard t the intended perfrmance f the medical device. Such trials are regulated by the RGF and wuld require the apprval f an ethics cmmittee. Trials using nn-ce marked devices are als regulated by the Medical Devices Regulatins (2002) 9.8. Interventinal Trial / Study - Any investigatin in human subjects which invlves sme frm f medical interventin: surgical, medical, r psychlgical, but which is nt classified as a CTIMP as defined in 9.6. Such studies are regulated by the RGF and wuld require the apprval f an ethics cmmittee. 9.9. Nn-interventinal Study - Any investigatin in human subjects, wh are patients, which is bservatinal and des nt invlve any interventin in additin t their nrmal clinical care. Such studies are regulated by the RGF and wuld require the apprval f an ethics cmmittee. 9.10. Investigatr Site File a file cntaining all the infrmatin that a site will need t cnduct a trial at that site. 9.11. Chief Investigatr -The individual, as identified in the ethics applicatin, wh takes verall respnsibility fr the cnduct f a clinical study. 9.12. Principal Investigatr - The individual wh takes n respnsibility fr cnduct f the study at a particular site. Page 4 f 9
9.13. Standard Operating Prcedure - SOPs are dcuments that describe the prcedures that shuld be fllwed t ensure cnsistency in the perfrmance f specific prcesses r activities. Respnsibilities 10. The Chief Executive has verall respnsibility fr this plicy. 11. The Medical Directr / Directr f R&D / R&D Lead / R&D Manager have delegated authrity n behalf f the Trust t review and apprve mnitring/audit plans and reprts. 12. Chief Investigatr (CI) / Principal Investigatr (PI): Overall respnsibility fr the cnduct f the trial; Facilitate access t trial dcuments and participant medical recrds, fr the purpses f mnitring, auditing and inspectins; Ensure nging cmmunicatin, thrugh cpying f relevant crrespndence with Research Ethics Cmmittees (REC) and MHRA. 13. Research and Develpment Staff has the respnsibility t prvide advice and infrmatin t investigatrs n issues f cmpliance; t prepare fr and cnduct the mnitring visit/audit/cmpliance check; t write the resultant reprt; and t cmplete fllw-up visits as required; t facilitate cmmunicatin between the Trust and the investigatr / study team; t update electrnic study files and database with new infrmatin derived frm ethics prgress reprts, annual safety reprts, end f study ntificatins fllwing the Trust R&D Standard Operating Prcedures. Cntent f the Plicy Trust Spnsred Clinical Trials f Investigatinal Medicinal Prducts (CTIMPs) 14. Prir t trial cmmencement, a mnitring plan will be written by R&D staff, in cnjunctin with the trials staff. The mnitring plan will define the apprach t be taken in line with the Risk-adapted Apprach t the Management f CTIMPs. 15. An initiatin visit will be cnducted prir t trial start t ensure that everything is in place and that staff are fully aware f their respnsibilities fr cmpliance with GCP. 16. During the trial, all trials spnsred by the Trust will be mnitred at least twice yearly with fllw-up visits if required. These mnitring visits will cmprise sme r all f the fllwing: examinatin f the cntents f the Trial Master File; examinatin f a selectin f Case Reprt Frms and the crrespnding medical ntes, fr the purpse f Surce Data Verificatin; and discussin f the trial prgress with the investigatr team. R&D staff will generate a mnitring reprt, utlining actins required, and will fllw up n these actins. 17. Peridic visits will be made t pharmacy fr the purpses f mnitring f IMP handling and examinatin f the relevant pharmacy files. Trust Hsted CTIMPs 18. A selectin f hsted trials will be audited. The selectin prcedure will, in the main, be randm, but will include the facility t select specific trials that have previusly been identified as high risk. 19. Audits will cmprise examinatin f the cntents f the Investigatr Site File; examinatin f a selectin f Case Reprt Frms and the crrespnding medical ntes; and interviews with the investigatr team. R&D staff will generate an audit reprt, which will be prvided t the investigatr, alng with any recmmended Page 5 f 9
actins. The trials team will respnd t the findings within the reprt, utlining any crrective actins t be cmpleted. Other Research Studies (Nn-CTIMPs) 20. In rder t avid duplicatin f effrt, the R&D team will endeavur t mnitr the prgress f research studies thrugh cpies f crrespndence with the relevant ethics cmmittee: prgress reprts; substantial amendments; end f study ntificatins. 21. Investigatr teams are required t assist with this prcess thrugh cpying f all such crrespndence t R&D. 22. The R&D staff will mnitr the submissin f such updates and update the R&D database accrdingly, thus ensuring that indemnity fr each study is nging. 23. These studies may be audited fr cmpliance with RGF and GCP, where it is deemed t be apprpriate. Cmpliance Checks All study types 24. The R&D team may als perfrm a cmpliance check n any study r grups f studies. This may be at the request f a study team; a result f an issue cming t light and being reprted t the R&D team; r as a randm selectin. Particular aspects f study management r participant safety are fcused n fr example the participant cnsent prcess r safety reprting. Training 25. All staff invlved in the cnduct f clinical trials will undertake training in Gd Clinical Practice (GCP) prir t beginning their invlvement in a trial. The prcess f mnitring and audit is cvered within this training. 26. All staff invlved in the cnduct f mnitring, audit and cmpliance checks receive training in the use f the trust R&D SOPs. Each individual s training needs will be identified thrugh annual appraisal and supervisin. Mnitring Cmpliance 27. Cmpliance with the dcument will be mnitred in the fllwing ways. Aspect f cmpliance r effectiveness being mnitred Staff f the Trust R&D Department will mnitr the implementatin f the plicy. Mnitring methd Review f database Respnsibility fr mnitring (jb title) The R&D Manager/Lead Frequency f mnitring At least annually Grup r Cmmittee that will review the findings and mnitr cmpletin f any resulting actin plan R&D Team and if required Directr f R&D. The Trust R&D Department review this plicy t reflect changes in legislatin and examples f best practice. Review f plicy R&D Lead and delegated staff At least Annually R&D Team and if required Directr f R&D. Page 6 f 9
Review 28. This plicy will be reviewed in 3 years, as set ut in the Plicy fr the Develpment and Implementatin f Prcedural Dcuments. 29. The Trust Management Executive has delegated authrity t the Research & Develpment Lead fr the apprval f any further supprting r assciated dcuments. References 30. The Medicines fr Human Use (Clinical Trials) Regulatins 2004 and Amendments 31. The Department f Health Research Gvernance Framewrk fr Health and Scial Care 2005 32. ICH Harmnised Tripartite Guideline fr Gd Clinical Practice. 33. MRC/DH/MHRA Jint Prject n the Risk-adapted Appraches t the Management f Clinical Trials f Investigatinal Medicinal Prducts Versin 28th March 2011 Equality Analysis 34. As part f its develpment, this plicy and its impact n equality, diversity and human rights has been reviewed, an equality analysis undertaken (see appendix attached) and in rder t minimize the ptential t discriminate, n adjustments have been identified: Hw des this plicy affect each characteristic? Prtected Characteristic: Disability (all disability including dementia and learning disability) Sex Age Race Sexual Orientatin Pregnancy and maternity Religin r belief Gender re-assignment Marriage r civil partnerships Carers Safeguarding peple wh are vulnerable Reasnable adjustments required Page 7 f 9
Dcument Histry Date f revisin Versin number Reasn fr review r update March 2006 1.2 Reviewed and Updated May 2007 1.3 Updated t reflect change in prcesses July 2010 2.0 Reviewed and Update September 2015 3.0 Reviewed and update transferred t new template Appendix 1: Equality Analysis Equality Analysis Plicy / Plan / prpsal name: Mnitring, Audit and Cmpliance Checks f Research Studies Date f Plicy: September 2015 Date due fr review September 2018 Lead persn fr plicy and equality analysis: R&D Lead Des the plicy /prpsal relate t peple? If yes please cmplete the whle frm. YES 1. Identify the main aim and bjectives and intended utcmes f the plicy. T ensure that the Trust has a rbust prcess in place t prvide cntinued assurance that the rights and wellbeing f trial participants are safeguarded, the participants will benefit frm the assurance that the trials undertaken at the OUH Trust are apprpriately managed and mnitred. 2. Invlvement f stakehlders. Based n the previus versin, this update has drawn n feedback frm researchers and ther staff including members f the R&D team. Evidence. Ppulatin infrmatin n www.healthprfiles.inf search fr Oxfrdshire. Disability Nt applicable Disability: learning disability Nt applicable Sex Nt applicable Age: Nt applicable Race: Nt applicable Sexual rientatin: Nt applicable Pregnancy and maternity: Nt applicable Religin r belief. Nt applicable Gender re-assignment. Nt applicable Marriage r civil partnerships: Nt applicable Carers Nt applicable Page 8 f 9
Safeguarding peple wh are vulnerable: Nt applicable Other ptential impacts e.g. culture, human rights, sci ecnmic e.g. hmeless peple Nt applicable Sectin 4 Summary f Analysis This plicy des nt shw any ptential t discriminate. The mnitring, audit r cmpliance checks (as well as the array f legislatin) gverning each trial ensures all patients are adequately prtected. Hw des the plicy advance equality f pprtunity? Nt applicable Hw des the plicy prmte gd relatins between grups? Nt applicable. Page 9 f 9