UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE

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1 UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE STANDARD OPERATING PROCEDURES University f Leicester (UL) SOP S-1016 UL Versin 3, Octber 2016 Prcedure in the Event f Nn-Cmpliance in Spnsred by University f Leicester OFFICE BASE & Enterprise Divisin University f Leicester Fielding Jhnsn Building University Rad Leicester LE1 7RH Effective Date: April 2017

2 Standard Operating Prcedure: S-1016 UL Prcedure in the Event f Nn-Cmpliance in Spnsred by University f Leicester Octber INTRODUCTION This Standard Operating Prcedure (SOP) describes the prcess fr respnding t any frm f nn-cmpliance identified in research spnsred by University f Leicester (UL), including audit findings, prtcl and / r regulatry vilatins, cntractual issues, and whistleblwing. This SOP will be referenced and implemented in line with the UL Cde f Cnduct. 2. SCOPE This SOP applies t all individuals cnducting research spnsred by the UL. 3. DEFINITIONS Frms f nn-cmpliance are described as critical, majr r ther in line with audit and inspectin prcesses f regulatry authrities. A critical nn-cmpliance can include instances where: The safety, well-being r cnfidentiality f participants has been jepardised r has the ptential t be jepardised. Reprted data are unreliable r absent. Inapprpriate, insufficient r untimely crrective actin has taken place regarding a majr nn-cmpliance. Where there are a number f majr nn-cmpliances Lack f adequate dcumentatin available t recnstruct the study r failure t maintain an apprpriate Trial Master File (TMF). A majr nn-cmpliance can include instances f : Significant and unjustified nn-cmpliance with relevant legislatin r Gd Clinical Practice (ICH GCP). A number f breaches f legislatin r GCP within ne area, indicating systematic quality assurance failure. A failure t cmply with legislative requirements including annual reprting requirements. An ther finding can be identified as : Any ther finding that is neither critical nr majr. 4. PROCEDURE Nn-cmpliance identified by whatever means, will be investigated using apprpriate mnitring and audit prcesses by the. The prcedures described belw are general, and each instance f nn-cmpliance will be assessed and respnded t n a case by case basis. Failure t respnd t reprted nn-cmpliance will result in escalatin frm ther t majr t critical. In this instance the issue will be escalated t the UL Spnsrship Cmmittee wh will decide an apprpriate curse f actin referencing the UL Cde f Cnduct. SOP S-1016 UL Prcedure in the Event f Nn-Cmpliance in Spnsred by University f Leicester (UL) Page 2 f 5 Versin 3 Oct 2016 NB: Paper cpies f this dcument may nt be mst recent versin. The definitive versin is held n the UL Cllege f Medicine, Bilgical Sciences and Psychlgy Website, pages.

3 4.1 Critical Nn-Cmpliance On identificatin f a critical nn-cmpliance as defined in sectin 3 the / (CI/PI) will be alerted by the. Depending n the nature f the critical nn-cmpliance, it may be necessary t give a ntificatin by with an utline f immediate actin required. The initial ntificatin will be fllwed up within 7 calendar days with a detailed reprt. Dependent n the nature f the nn-cmpliance the trial may be suspended with immediate effect. The may suspend all trials assciated with the CI/PI at their discretin in cnsultatin with the Directr f and Innvatin. Identificatin f a critical nn-cmpliance may prmpt audit and clse mnitring f assciated trials. Suspensin f the trial will be ntified by the Spnsr t the Main Ethics Cmmittee (REC) via the Health Authrity (HRA) and the MHRA as apprpriate. The CI must respnd within 30 calendar days frm the date f receipt f a detailed ntificatin. It is expected that the Crrective Actin Preventative Actin (CAPA) template as detailed in SOP S-1012 UL will be used in all cases. This will ensure that the CI explains clearly what actin they will take. It is nt necessary that all the actin will have been taken within the 30 days but it is expected that a plan f cmpletin is utlined. Nnrespnse within this timeframe will lead t suspensin f the trial in all cases, and pssible suspensin f assciated trials. If deemed apprpriate, submissin f a substantial amendment t restart the trial will be permitted by the Spnsr nce the nn-cmpliance is reslved r adequate plans are in place t prevent repeat incidents. Trials spnsred by UL that have been suspended will be clsely mnitred, prir t restarting, after the first new participant is entered and regularly thereafter until the is satisfied the trial is fully cmpliant. On identificatin f a critical nn-cmpliance all research staff will be required t retrain in Gd Clinical Practice and t be assessed / reassessed in taking cnsent. 4.2 Majr Nn-Cmpliance On identificatin f majr nn-cmpliance as defined in sectin 2 the CI/PI will be alerted by the. It shuld be nted that evidence f several majr nn cmpliances has the ptential t escalate findings t the level f critical nn-cmpliance. On identificatin f a majr nn-cmpliance the CI/PI will have 30 calendar days in which t respnd and cmplete the CAPA plan. This requires the CI/PI t explain what actin they will take, nt necessarily take the actin at this pint. Failure t respnd t ntificatin f majr nn-cmpliance within 30 calendar days will cnstitute a critical nn-cmpliance as per sectin 3 and may result in suspensin f the trial. 4.3 Other Nn-Cmpliance On identificatin f ther nn-cmpliance, that is neither majr nr critical as defined in sectin 3 the CI / PI will be alerted by. SOP S-1016 UL Prcedure in the Event f Nn-Cmpliance in Spnsred by University f Leicester (UL) Page 3 f 5 Versin 3 Oct 2016 NB: Paper cpies f this dcument may nt be mst recent versin. The definitive versin is held n the UL Cllege f Medicine, Bilgical Sciences and Psychlgy Website, pages.

4 Frm the date f ntificatin t the CI/PI there will be 30 calendar days in which t frmulate an actin plan in respnse t the nn-cmpliance. This requires the CI/PI t explain what actin they will take, nt necessarily take the actin. A CAPA plan must be cmpleted as fr 4.1 and 4.2. Failure t respnd t ntificatin f nn-cmpliance will cnstitute a majr nn-cmpliance as per sectin MULTI-CENTRE STUDIES Where nn-cmpliance is identified at any site, the Spnsr, in cllabratin with the and the & Develpment / Innvatin (R&D/I) at the site, will manage instances in line with lcal standard perating prcedures. Where specific issues f nn-cmpliance fall utside f lcal standard perating prcedures, the Spnsr standard perating prcedures will be used as referenced and may result in the site Spnsr permissin being withdrawn. In cases where the Spnsr SOP is used, the prcess will be the same as detailed in Sectin 4, but it is expected that the respnse be cmmunicated back t the thrugh the CI. 6. RESPONSIBILITIES Respnsibility Undertaken by / 1 / 2 / 3 / / / r r and R&D / I Directr Activity The / is respnsible fr ensuring that the trial cmplies with legislatin, Gd Clinical Practice and the prtcl fr the trial. The / is respnsible fr respnding t ntificatins f nncmpliance in line with this SOP. The / is respnsible fr ensuring the research team are apprpriately trained, experienced and qualified t deliver Gd Clinical Practice, take infrmed participant cnsent and deliver the prtcl (see SOP S-1020 UL Training in Staff Engaged in Clinical and SOP S-1021 Infrmed Cnsent fr ). The will undertake t mnitr and utilise quality assurance audit fr trials, accrding t risk assessment which will be influenced by findings f nn-cmpliance. The will reprt nncmpliance t the / and request respnse frm them. The Directr f and Develpment / Innvatin will take the final decisin whether t suspend a trial and assciated trials. SOP S-1016 UL Prcedure in the Event f Nn-Cmpliance in Spnsred by University f Leicester (UL) Page 4 f 5 Versin 3 Oct 2016 NB: Paper cpies f this dcument may nt be mst recent versin. The definitive versin is held n the UL Cllege f Medicine, Bilgical Sciences and Psychlgy Website, pages.

5 Respnsibility Undertaken by 7 r r r r Activity The r will decide when actin is sufficient t reinstate a trial r trials. The r will advise in respect f nn-cmpliance and prvide access t GCP training and cnsent assessment as apprpriate. The will escalate actin if respnse is insufficient. The will undertake clse mnitring and audit f reinstated trials. This table is used t track the develpment and apprval f the dcument and any changes made n revised / reviewed versins Authr / Lead r: Reviewed by: Apprved by: DEVELOPMENT AND APPROVAL RECORD FOR THIS DOCUMENT Wendy Gamble Jb Title: UL Spnsrship Management and Operatins Grup (RSMOG) Prfessr Nigel Brunskill Date Apprved: Date Issue Number Reviewed By July 2 Wendy 2015 Gamble Oct Wendy Gamble REVIEW RECORD Descriptin Of Changes (If Any) Changes f lg frnt page and minr changes t bring in line with UHL SOP. Additin f HRA prcess and crrectin f text relating t fraud and miscnduct SOP, replacing with rewrding t reference the University Cde f Cnduct, plus minr administrative changes. DISTRIBUTION RECORD: Date Name Dept Received SOP S-1016 UL Prcedure in the Event f Nn-Cmpliance in Spnsred by University f Leicester (UL) Page 5 f 5 Versin 3 Oct 2016 NB: Paper cpies f this dcument may nt be mst recent versin. The definitive versin is held n the UL Cllege f Medicine, Bilgical Sciences and Psychlgy Website, pages.