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Research Ethics ServiceNorth East - Tyne & Wear South Research EthicsCommitteeAnnual Report01 April 2015 - 31 March 2016

Part 1 – Committee Membership and TrainingName of REC:North East - Tyne & Wear South Research Ethics CommitteeType of REC:RECs recognised to review CTIMPS in patients - type iiiType of Flag:Phase 1 Studies in PatientsChair:Mr Paddy StevensonVice-Chair:Mr Ian CampbellAlternate Vice-Chair:Miss Christine Bullmore (up to 31/07/2015)Mrs Debra J Lett (from 01/08/2015)REC Manager:Miss Kathryn MurrayREC Assistant:Miss Sarah Prothero – to September 2015Miss Kerry Dunbar – from September 2015Committee Address:HRA JarrowJarrow Business CentreRolling Mill RoadJarrowNE32 3DTTelephone:020 7104 @nhs.netNorth East - Tyne & Wear South Research Ethics Committee Annual ReportPage 2

Chair’s overview of the past year:Well another year has passed with me at the helm of the good ship Tyne and Wear South. As with everyyear we have had some valued colleagues leave which was generally down to the increasing workload all ofus face away from ethics. I would like to take this opportunity to thank Sophie Barron for her insight intoyoung people’s research, Christine Bullmore for her extensive insight into ethical issues and her guidanceover the years since I joined the committee. Dr Chris Plummer who’s calm methodical views over the lasteight years have been invaluable and finally Dr Sunnah Cook and Mr Malcolm Khan who were with us for ashort time but I valued their input. With people leaving we were fortunate enough to gain some excellent newmembers and I look forward to working with Louise Jones and Rachel Smith over the next few years.Despite the changes to our committee our output has been exemplary; we have increased our workload overthe past year from 45 studies being reviewed at full committee in 2013/14 to 55 in 2015/16 as well asincreasing our full committee meetings from 9 to 10. With the increase in studies reviewed this hasaccompanied an increase in complexity with CTIMP reviews increasing from 16 (35.5%) to 22 (40%).Despite the changes in staffing and the increase in workload it is satisfying to report that our standards havenot only remained high but have improved. We had no inquorate meetings in the reporting period and despitethe increases in number and complexity we reported no breaches to the timeline targets. I am also proud toreport that in June 2015 we were notified by the Health Research Authority that our Tyne and Wear Southwas one of only 15 Research Ethics Committees to meet the key performance indicators for full REC review,Proportionate review and Substantial amendments over 95% of the time. This along with being classed asexcellent in the recent Shared Ethical Debate exercise clearly points out the outstanding work Kathryn andKerry put in to support of myself and Ian Campbell, Our Vice Chair.I’m looking forward to another interesting year with the team and I hope you find this an interesting read.North East - Tyne & Wear South Research Ethics Committee Annual ReportPage 3

North East - Tyne & Wear South Research Ethics Committee MembershipNameProfessionMs Sam BarronClinical Lead, Speechand Language TherapistStudentClinical EffectivenessAdvisorEmergency Planning CoordinatorPharmacySenior ResearchAssistant and Lecturer inNursing Skills and StaffNurse (Bank)ServiceImprovement/Organisational Development LeadConsultant SurgeonFaculty ResearchAdministratorLawyer - RetiredManager NewcastleBrain Tissue ResourceConsultant ClinicalOncologist (retired)Research ParamedicConsultant CardiologistBarristerResearch OperationsManagerRetired - Interim Directorof OperationsMs Sophie BarronMr John BlenkinsoppMiss Christine BullmoreMr Ian CampbellDr Dorothy CoeDr Susannah CookMr Obi IwuchukwuMrs Louise JonesMr Malcolm KhanMrs Debra J LettDr Helen H LucraftMr Graham McClellandDr Chris PlummerMiss Rachel SmithMr Paddy StevensonDr Kate WilsonExpert orLayExpertDatesAppointed01/06/2014Lay PlusLay 31/07/2015ExpertLay12/06/201201/05/2014Lay Plus01/09/201411/05/2015ExpertLay Plus07/01/201323/09/201531/03/2016Lay 013ExpertExpertLay Lay08/09/2014Left28/09/2015North East - Tyne & Wear South Research Ethics Committee: Deputy MembersNameProfessionStatusMeeting date attendedNorth East - Tyne & Wear South Research Ethics Committee: Co-opted MembersNameMs Linda ChaddMiss Hannah StevensonProfessionLibrary Assistant &ArchivistData Manager, ClinicalResearchStatusLay PlusMeeting date attended27/07/2015Lay28/09/2015North East - Tyne & Wear South Research Ethics Committee Annual ReportPage 4

North East - Tyne & Wear South Research Ethics Committee: Members’ Declarations ofInterest:NameMs Sam BarronMr John BlenkinsoppMr Ian CampbellDr Dorothy CoeMrs Louise JonesMrs Louise JonesMrs Debra J LettDr Helen H LucraftMr Graham McClellandMiss Rachel SmithMr Paddy StevensonDr Kate WilsonDeclaration of InterestWorks as a Clinical Lead, Speech and LanguageTherapist through Northumbria Healthcare NHSFoundation Trust.Has involvement in training charities in evidencebased practice but has no active part in research.Member of the Hartlepool NHS Foundation TrustResearch Evaluation Committee (Internal PeerReview System).Member of the Newcastle upon Tyne Hospital NHSFoundation Trust R&D approval Committee and theR&D Trust ExecutiveWorks as a Senior Research Assistant atNorthumbria University. No further interestsdeclared.Coordinates ethical review process within role;however, due to the nature of the department,these generally do not require NHS review.Involved in the support of the University EthicsAdvisory Committee in previous role with DurhamUniversity.Coordinates the ethical review process within theFaculty of Agriculture, Science and Engineering atNewcastle University but has no direct involvementthe review.Employee of Newcastle University. Manager ofNewcastle Brain Tissue Resource, a researchtissue bank which supplies samples to approvedresearch projects. Member of managementcommittee approving such projects. Tissue bankreceives funding from the Medical ResearchCouncil, Alzheimer’s Research UK and Alzheimer’sSociety and the NIHR via the Biomedical ResearchCentre and Unit.Trustee of St Oswalds Hospice, Gosforth,Newcastle and Public Governor of NewcastleHospitalsMember of the College of Paramedics. Undertakinga PhD which is based at Newcastle UniversityStroke Research Group. Research Paramedic forNEAS.No interests declared.Manager of Newcastle Hospitals Research teamhowever any active involvement had in a researchapplication is declaredNone DeclaredNorth East - Tyne & Wear South Research Ethics Committee Annual 09/11/201510/02/201610/02/2016Page 5

Meetings for Full Ethical Review 01 April 2015 - 31 March 01/201629/02/201621/03/2016Number of Members Presentat Meeting1211109910108111010 full committee meetings were held during the reporting period.Proportionate Review Sub-Committee Meetings held during 01 April 2015 - 31 March 01507/12/201512/01/201610/02/201610/03/2016Number of Members Presentat Meeting3333333333311 proportionate review sub-committee meetings were held during the reporting period.Sub-Committee Meetings held during 01 April 2015 - 31 March 0/07/201503/08/2015North East - Tyne & Wear South Research Ethics Committee Annual ReportNumber of Members Presentat Meeting22232222422Page 6

22222232236 sub-committee meetings were held during the reporting period.Details of inquorate meeting held:01 April 2015 - 31 March 2016DateReasonAction takenNorth East - Tyne & Wear South Research Ethics Committee Annual ReportPage 7

Attendance of Members at full committee meetings:01 April 2015 - 31 March 2016NameMr Ian CampbellDr Dorothy CoeMr Graham McClellandMrs Debra J LettMr Paddy StevensonDr Kate WilsonMr John BlenkinsoppDr Helen H LucraftMs Sam BarronMs Sophie BarronMrs Louise JonesMiss Rachel SmithDr Chris PlummerMiss Christine BullmoreMr Malcolm KhanNumber ofMeetingsAttended101010999887444321Attendance of Members at proportionate review sub-committee meetings: 01 April 2015 31 March 2016NameMr Paddy StevensonMrs Debra J LettMr John BlenkinsoppMr Ian CampbellDr Dorothy CoeMs Sam BarronDr Helen H LucraftMr Graham McClellandDr Kate WilsonMs Sophie BarronMiss Christine BullmoreDr Chris PlummerNumber ofMeetingsAttended654432222111Attendance of Members at sub-committee meetings: 01 April 2015 - 31 March 2016NameMr Paddy StevensonMrs Debra J LettMr Ian CampbellMs Sam BarronNorth East - Tyne & Wear South Research Ethics Committee Annual ReportNumber ofMeetingsAttended332773Page 8

Dr Dorothy CoeDr Chris PlummerMr John BlenkinsoppDr Kate WilsonMiss Christine BullmoreNorth East - Tyne & Wear South Research Ethics Committee Annual Report33221Page 9

Training 01 April 2015 - 31 March 2016Name of MemberMs Sophie BarronMs Sam BarronMrs Louise JonesDate04/06/201504/06/201513/01/2016Mrs Louise JonesMrs Louise Jones10/02/201611/03/2016Mrs Louise JonesMrs Debra J LettMr Paddy StevensonMr John BlenkinsoppMr Ian CampbellMr Graham McClellandMiss Christine BullmoreDr Helen H LucraftDr Dorothy CoeDr Kate 3/2016North East - Tyne & Wear South Research Ethics Committee Annual ReportEvent(s) attendedRegional Members Training DayRegional Members Training DayAssessing the Consequences(benefits and harms) ofResearchNew Members InductionGenetic and Genomic Research- Previously Advanced HTANational Members Training DayRegional Members Training DaySelf-Directed Learning LogNational Members Training DaySelf-Directed Learning LogSelf-Directed Learning 2015/16Regional Members Training DayRegional Members Training DayRegional Members Training DaySelf-Directed Learning LogPage 10

PART 2: REC WORKLOAD AND ACTIVITY DURING THE REPORTING PERIODTable 1: Applications assigned to a full committee meeting held within the reportingperiod:Applications for full ethical review – Study TypeClinical Trial of Investigational Medicinal ProductPhase 1Gene TherapyResearch Tissue Bank (including renewals)Research Database (including renewals)OthersTotal Applications 8100Table 2: Breakdown of full applications and other activity during reporting periodNumber of applications made invalid by the REC ManagerNumber of applications withdrawn prior to the meetingNumber of student applications reviewedNumber of paediatric applications reviewedNumber of device applications reviewedNumber of prisoner applications reviewedNumber of applications involving adults unable consent reviewedNumber of applications reviewed that are funded by the US DHHSNumber of qualitative applications reviewed2010740002Table 3: Decisions given at meetings held within the reporting periodDecisions taken at meetings following review ofapplicationsFavourable Opinion with Standard ConditionsFavourable Opinion with Additional ConditionsUnfavourable OpinionProvisional OpinionProvisional Opinion Pending Consultation with RefereeTotalNumber of studies sent back to full committee meetingfor final rth East - Tyne & Wear South Research Ethics Committee Annual ReportPage 11

Table 4: Summary of current status of applications reviewed during the reporting periodStatus of applications at date of generation of reportFurther Information Favourable Opinion with StandardConditionsFurther Information Favourable Opinion with AdditionalConditionsFurther Information Unfavourable OpinionFavourable Opinion with Standard ConditionsFavourable Opinion with Additional ConditionsUnfavourable OpinionProvisional OpinionProvisional Opinion Pending Consultation with RefereeFurther Information response not completeNo decision entered on systemNumber of studies withdrawn after the 12.731.820.000.000.000.000.00100North East - Tyne & Wear South Research Ethics Committee Annual ReportPage 12

Table 5: Applications assigned to a proportionate review sub-committee within the reportingperiod31Total Applications ReviewedTable 6: Breakdown of PRS applications and other activity during reporting period:Number of applications made invalid by the REC ManagerNumber of studies withdrawn prior to the meetingNumber of student applications reviewedNumber of paediatric applications reviewedNumber of device applications reviewedNumber of qualitative applications reviewed3113407Table 7: Decisions given at proportionate review sub-committee meetings held within thereporting periodDecisions taken at proportionate review subcommittee meetingsFavourable Opinion with Standard ConditionsFavourable Opinion with Additional ConditionsNo Opinion transfer to full committee for reviewProvisional OpinionUnfavourable 00North East - Tyne & Wear South Research Ethics Committee Annual ReportPage 13

Table 8: Other Management Information based on the number of completed applications forthe reporting period:Average number of applications reviewed per full meetingNumber of completed applications for full ethical reviewNumber of completed applications for full ethical review over60 daysNumber of completed applications over 60 days as a % oftotalNumber of completed applications for full ethical review over40 daysNumber of completed applications over 40 days as a % oftotalNumber of days taken to final decision – average (mean)Number of completed proportionate review applications forethical reviewNumber of completed proportionate review applications forethical review over 14 daysNumber of completed proportionate review applications over14 days as a % of totalNumber of SSAs (non-Phase 1) reviewedNumber of completed applications for SSA review over 25daysNumber of completed applications for SSA review over 25days as % of all non- Phase 1 SSAsNumber of SSAs (Phase 1) reviewedNumber of completed applications for SSA review over 14daysNumber of completed applications for SSA review over 14days as % of all Phase 1 er of substantial amendments reviewedNumber of completed substantial amendments over 35 daysNumber of completed substantial amendments over 35 daysas a % of total substantial amendmentsNumber of completed substantial amendments over 28 daysNumber of completed substantial amendments over 28 daysas a % of total substantial amendments11000.00%Number of modified amendments reviewedNumber of completed modified amendments over 14 daysNumber of completed modified amendments over 14 days asa % of total modified amendments000.00%Number of minor amendments receivedNumber of substantial amendments received for informationNumber of substantial amendments received for newsites/PIsNumber of annual progress reports receivedNumber of safety reports receivedNumber of Serious Adverse Events receivedNumber of final reports received104027North East - Tyne & Wear South Research Ethics Committee Annual Report21.82%5450117Page 14

North East - Tyne & Wear South Research Ethics Committee Annual ReportPage 15

Table 9.1: Breakdown of current status of all full applications reviewed within the reporting periodFurther Information Favourable Opinion with Standard ConditionsREC ReferenceTitle15/NE/0147Improving Patient's First Point of Contact (Version 001)15/NE/0148AF219-010 Dose Escalation in Subjects with Refractory Chronic Cough15/NE/0149Phase 2 study in Patients with Recurrent or Metastatic SCCHN15/NE/0155Antiplatelet therapy in COPD (APPLE-COPD:ICON 2)15/NE/0190Physical Activity in Heart Failure15/NE/0199Molecular Profiling of Primary and Metastatic Penile Cancer15/NE/0212A Fulranumab study of Osteoarthritis of the hip or knee (3003)15/NE/0213CASCADE II -Version115/NE/0216Alcohol Prevalence in Pregnancy (APP) Study15/NE/0217Brain maturation and neurodevelopmental outcome in preterm adults15/NE/0243Investigating a Self-Care Model for Patients with Prostate Cancer15/NE/0251The utility of feNO in the differential diagnosis of chronic cough15/NE/0252MK-3475 (Pembrolizumab) in Subjects with Classical Hodgkin Lymphoma15/NE/0274EORTC 132015/NE/0277OPTIMUM15/NE/0278Efficacy & safety of 2 different aflibercept regimens in nAMD subjects15/NE/0284PRICKLE follow up15/NE/0307Does self-compassion positively relate to birth experience?15/NE/0310The Feasability of Endoscopic Ultrasound-Guided Portal Vein Manometry15/NE/0329Z7219LO2 Safinamide long-term treatment in fluctuating Parkinson’s Dis15/NE/0331Dabigatran Presence in Breast Milk (DALMATION)15/NE/0358Phase II HRV16 study examining PrEP-001 in asthmatics15/NE/0360Effects of an exercise programme on women with breast cancer. v 1.015/NE/0379Non-invasive vagus nerve stimulation in Primary Sjogrens Syndrome15/NE/0381ALTAR15/NE/0382MASS: Muscle and Ageing Science Study (V.1)15/NE/0390Myotubular and Centronuclear Patient Registry15/NE/0392HYPnosis for tastE in Head And Neck CancEr (HYP-EnHANCE)15/NE/0394A Phase 2a study of multiple doses of BTA-C585 against RSV infection16/NE/0027B9991009 Phase 3, avelumab for Platinum-Resistant Ovarian Cancer16/NE/0028SOLAR Study16/NE/0031Phase 1b study of Foxy5 in Metastatic Breast, Colon or Prostate CancerNorth East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual ReportNumber of Days on 4282223243127403126Page 16

16/NE/008916/NE/009416/NE/0097COSMIC study - A Feasibility studyD4190C00006 - Ph 1b MEDI4736 in Advanced Non-Small Cell Lung CancerDose-Ranging Study of Delayed-Release Deferiprone in ParkinsonStudy of UTTR1147A in Healthy Volunteers & Ulcerative Colitis PatientsRelationship between PA and metabolic control in children with T1DM.COG-PBC StudyAcellular allogeneic peripheral nervesLong-term observational study of subjects from Tanezumab studies2730292324252333Further Information Favourable Opinion with Additional ConditionsREC ReferenceTitle15/NE/0119The effect of whey protein on glycaemia and appetite in T2D15/NE/0312Residual adrenal function in Addison's disease: PREGENERAD15/NE/0357SBoCK16/NE/0023BN29552 A Study of Crenezumab in Patients with Prodromal to Mild ADNumber of Days on Clock25372336Further Information Unfavourable OpinionREC ReferenceTitleNumber of Days on ClockFavourable Opinion with Standard ConditionsREC ty study for a randomised trial of first-line respiratory support16/NE/0096Surveillance of emergency canthotomy and cantholysis in the UKNumber of Days on Clock211721Favourable Opinion with Additional ConditionsREC ReferenceTitle15/NE/0227Knowledge and understanding of cognitive impairment15/NE/0249ETA30515/NE/0330ASTEROID in clinical practice15/NE/0349OSA in Pregnancy: Is STOPBANG Predictive?16/NE/0008I-KID: Infant KIdney Dialysis and filtrationNumber of Days on Clock1728242228North East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual ReportPage 17

16/NE/006816/NE/0083Mehealth for Rheumatoid ArthritisViral Challenge Asthma Phenotype (VCAP) Study2322Unfavourable OpinionREC ReferenceTitle15/NE/0355Cross-cultural metaphors of pain and pain managementNumber of Days on Clock22Provisional OpinionREC ReferenceTitleNumber of Days on ClockProvisional Opinion Pending Consultation with RefereeREC ReferenceTitleNumber of Days on ClockFurther information response not completeREC ReferenceTitleNumber of Days on ClockWithdrawn after the meetingREC ReferenceTitleNumber of Days on ClockTable 9.2: Breakdown of current status of all PRS applications reviewed within the reporting periodFurther Information Favourable Opinion with Standard ConditionsREC ReferenceTitle15/NE/0246PFT after KASS15/NE/0250Evaluating osteogenic properties of marine-organism derived extracts16/NE/0018AMR bacteria in diabetic foot ulcersNumber of Days on Clock8811Further Information Favourable Opinion with Additional ConditionsNorth East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual ReportPage 18

REC ReferenceTitleNumber of Days on ClockFurther Information Unfavourable OpinionREC ReferenceTitleNumber of Days on ClockFavourable Opinion with Standard ConditionsREC ReferenceTitle15/NE/0124Assessing a Measure of Participation Version 1.015/NE/0132Physical fitness and appetite before and after bariatric surgery15/NE/0136Hydrate for Health15/NE/0138Inflammatory, metabolic, endocrine, immunological pathways in arteries and veins15/NE/0200Development and Evaluation of a Neurorehabilitation Outcomes Database15/NE/0201PLACE Qualitative Sub-Study15/NE/0202Growth in infants with Congenital Diaphragmatic Herniae15/NE/0247Epidemiology of breast cancer subtypes defined by ER and HER2 status15/NE/0283Enterovirus D68 in a Regional UK Centre15/NE/0285Umbilical cord Cell Model of Inflammation and Disease15/NE/0384AIDE Project15/NE/0387Olympus Lucera vs Olympus Elite - an observational study15/NE/0422A Survey of patient education in atopic eczema15/NE/0424Sleep and Psoriasis Qualitative Study16/NE/0026Morbidity and Mortality in Tetralogy of Fallot16/NE/0055ROUGE V116/NE/0058Post-traumatic stress & growth in childhood cancer survivors / parents16/NE/0059Derivation of human ear stem cells from fetal tissues16/NE/0090Psychiatric Genetic Counselling: A Pilot Study16/NE/0092Impulsivity and Executive Function Following Traumatic Brain InjuryNumber of Days on Clock8888101013898109141391110101213Favourable Opinion with Additional ConditionsREC ReferenceTitle15/NE/0326NEURONAL AUTOANTIBODIES IN IRRITABLE BOWEL SYNDROME15/NE/0421Incidence of Malignancy in Patients with Lysosomal Storage Disorders16/NE/0019Asthma medication adherence in young peopleNumber of Days on Clock81310North East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual ReportPage 19

16/NE/005616/NE/0088Patient Discharge from acute medicine: Observation of practiceStudy assessing patient perception and adherence to medicine1312Unfavourable OpinionREC ReferenceTitle16/NE/0091Exploring the psychosocial needs of amputee patients during recoveryNumber of Days on Clock14Provisional OpinionREC ReferenceTitleNumber of Days on ClockFurther information response not completeREC ReferenceTitleNumber of Days on ClockWithdrawn after the meetingREC ReferenceTitleNumber of Days on ClockNorth East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual ReportPage 20

Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting periodFavourable opinionAmendment RECReference06/Q0904/78/AM39TitlePeri-operative Chemotherapy & Bevacizumab in GastricCancer (ST03)06/Q0904/78/AM43Peri-operative Chemotherapy & Bevacizumab in GastricCancer (ST03)07/H0904/77/AM19Study of INT-747 in Primary Bilary Cirrhosis- Version 107/H0904/77/AM20Study of INT-747 in Primary Bilary Cirrhosis- Version 110/H0904/49/AM20CFTY720D2399 a possible treatment for MS extension study11/NE/0039/AM11Open Label Brivaracetam Study in Patients with Partial OnsetSeizures11/NE/0039/AM12Open Label Brivaracetam Study in Patients with Partial OnsetSeizures11/NE/0334/AM05Extension Study of rhuMAb BETA7 in patients with UlcerativeColitis12/NE/0018/AM03Virtual reality intervention for anxiety in children with ASDversion112/NE/0160/AM03ICON 112/NE/0225/AM06Fatigue fingerprints12/NE/0234/AM04RCT of CPAP in patients with diabetic retinopathy and OSA(ROSA Trial)VersionDateSubstantialAmendment 10,25/0SubstantialAmendment 11 7/1SA-201 IB v13Addendum 8 PIS ISubstantialAmendment 17 SA2SubstantialAmendment 9 - 9/9/SubstantialAmendment 8,28/07SubstantialAmendment 9 22/1SubstantialAmendment 4,27/06SubstantialAmendment 3,23/07SubstantialAmendment 3,02/04SubstantialAmendment 3,27/04Amendment 408/07/2015Number of Days 51313/04/20151529/04/20151413/03/201523North East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual ReportPage 21

12/NE/0235/AM08Paediatric Liver Transplant study with Everolimus12/NE/0323/AM17First in Human Study of VX-970 in Advanced Solid TumorsVX12-970-00112/NE/0323/AM18First in Human Study of VX-970 in Advanced Solid TumorsVX12-970-00112/NE/0323/AM22First in Human Study of VX-970 in Advanced Solid TumorsVX12-970-00112/NE/0323/AM24First in Human Study of VX-970 in Advanced Solid TumorsVX12-970-00112/NE/0333/AM10Tasquinimod in patients with advanced/ metastaticHCC,GC,OAC and RCC12/NE/0355/AM03129Xe/3He MRI in idiopathic pulmonary fibrosis patients.Version 1.012/NE/0355/AM04129Xe/3He MRI in idiopathic pulmonary fibrosis patients.Version 1.013/NE/0049/AM12BAY 94-9027 pediatric pharmacokinetics, safety, and efficacytrialObjective movement assessment in preterm infants ic prophylaxis for clean intermittent catheterisation v1.013/NE/0196/AM17Antibiotic prophylaxis for clean intermittent catheterisation v1.013/NE/0196/AM22Antibiotic prophylaxis for clean intermittent catheterisation v1.0SubstantialAmendment 7,30/04SubstantialAmendment 12,07/0SubstantialAmendment 13,10/0SubstantialAmendment 15,02/0SubstantialAmendment 17 18/SubstantialAmendment 6,08/06SubstantialAmendment 3,17/03SubstantialAmendment 4 20/1SubstantialAmendmetnt 7 - 18/SubstantialAmendment 1,16/04SubstantialAmendment 11SubstantialAmendment 12,20/0SubstantialAmendment 15,28/0North East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual /08/201526Page 22

13/NE/0196/AM24Antibiotic prophylaxis for clean intermittent catheterisation ance Study of Niraparib/Placebo in Patients withOvarian Cancer13/NE/0270/AM03CD64 as a marker of prosthetic joint infection13/NE/0280/AM06AZ: D0816C00005 - Ph. 1 Study Hepatic Function/Impairment13/NE/0293/AM04PK study of Carfilzomib in Patients with Hepatic Impairment13/NE/0336/AM04Trial of Proton Pump Inhibitors in Throat Symptoms13/NE/0336/AM05Trial of Proton Pump Inhibitors in Throat Symptoms13/NE/0342/AM06OPTIMISTIC13/NE/0344/AM13A monotherapy study of ertugliflozin in participants with T2DM13/NE/0344/AM14A monotherapy study of ertugliflozin in participants with T2DM13/NE/0344/AM15A monotherapy study of ertugliflozin in participants with T2DM13/NE/0355/AM04AMG145 vs Ezetimibe in Statin IntolerantHypercholesterolemic SubjectsSubstantialAmendment 16 29/SubstantialAmendment 1,04/03SubstantialAmendment 3 11/9SubstantialAmendment 4 5/12SubstantialAmendment 4 23/9SubstantialAmendment 7 11/1SubstantialAmendment 2 - 9/9/SubstantialAmendment 3 - 7/1SubstantialAmendment 6,04/06SubstantialAmendment 8,13/05SubstantialAmendment 9,31/07SubstantialAmendment 10 23/SubstantialAmendment 3 13/8North East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual 13/08/201527Page 23

14/NE/0010/AM02Phase I study of PM01183 with cisplatin in advanced solidtumors.14/NE/0016/AM07Ibodutant for relief of irritable bowel syndrome (Nak-06)14/NE/0017/AM08Ibodutant for relief of irritable bowel syndrome (Nak-07)14/NE/0073/AM04BI836845 in women with Breast Cancer.14/NE/0073/AM06BI836845 in women with Breast Cancer.14/NE/0073/AM07BI836845 in women with Breast Cancer.14/NE/0073/AM08BI836845 in women with Breast Cancer.14/NE/0127/AM03Validation of a palliative needs assessment tool in ILD (NA-ILDstudy)14/NE/0147/AM02D081CC00001, PK study Olaparib in combination withEndocrine therapy14/NE/0151/AM04THYRoxine in Acute Myocardial Infarction (ThyrAMI)14/NE/0151/AM05THYRoxine in Acute Myocardial Infarction (ThyrAMI)14/NE/1040/AM02Pfizer A3921092 - Phase 3 Tofacitinib (Active PsA) ExtensionStudy14/NE/1040/AM03Pfizer A3921092 - Phase 3 Tofacitinib (Active PsA) ExtensionStudySubstantialAmendment 3,24/04SubstantialAmendment 5 16/9SubstantialAmendment 5 ChanSubstantialAmendment 2SubstantialAmendment 3 - 8/9/SubstantialAmendment 4 14/1SubstantialAmendment 5 4/12SubstantialAmendment 3 24/1SubstantialAmendment 1 23/6SubstantialAmendment 3,17/03SubstantialAmendment 4,08/05SubstantialAmendment 2,30/03SubstantialAmendment 3,23/01North East - Tyne & Wear South Research Ethics Committee Research Ethics Committee Annual 13/05/201512Page 24

14/NE/1040/AM04Pfizer A3921092 - Phase 3 Tofacitinib (Active PsA) ExtensionSt

North East - Tyne & Wear South Research Ethics Committee Annual Report Page 2 Part 1 – Committee Membership and Training Name of REC: North East - Tyne & Wear South Research Ethics Committee Type of REC: RECs recognised to review CTIMPS in patients - type iii Type of Flag: Phase 1 Studies in Patients Chair: Mr Paddy Stevenson Vice-Chair: Mr Ian Campbell

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