executive summary of annual report for the business

Executive Summary of Annual Report for the Business Services Organisation (BSO): Office for Research Ethics Committees Northern Ireland (ORECNI) for the Financial

Year 2018 to 2019

Left to Right: Committee member training day 2019. Dr Alastair Walker (Chair of HSC REC A), Mrs Julie Erskine (Chair of the BSO Board), Dr Anne Moorhead (Vice-Chair of HSC REC B), Dr Hugh Davies (Health Research Authority, Chair of the HRA Oxford A REC); Sue Trouton (Alternate Vice-Chair of HSC REC B), Dr Siobhan McGrath (Head of the ORECNI), Prof Patrick Murphy (Chair of HSC REC B)

Firstly a sincere thank you to all the volunteer Health and Social Care Research Ethics Committee (HSC REC) members from HSC RECs A and B who along with the support from the ORECNI staff and have continued to provide the service on which many research customers rely. I am obliged to all, as are the researchers and research sponsors who rely on the efficiency and predictability of the service, and the participants who are invited to take part in research that has been the subject of a robust review provided by the ORECNI service. The service continues to receive excellent feedback from its customers. I would particularly like to draw attention to the Committee Chairs’ summaries in the body of this report which highlight the spirit of cooperation and team work which enables success for this service.

The average workload per meeting per committee is equivalent or greater than other UK jurisdictions. The service has been delivered within budget and financial savings required.

It was with much pride that I am able to report that both HSC RECs A and B continue to have the most efficient key performance indicators in the UK exceeding the KPI targets on ethical decision timelines in all areas. The ORECNI will continue to work with the other UK ethics partners in England, Scotland and Wales and the Business Services Organisation (BSO) to support its mission statement and corporate objectives as follows:

ORECNI Mission

• to protect the rights, safety, dignity and well-being of research participants; and • to facilitate and promote ethical research that is of potential benefit to participants,

science and society. The RECs considered during the financial year (1st April 2018 to 31st March 2019) 162 new research proposals involving human subjects (their tissue or data), which took place within the HSC and/ or wider NHS or within private clinical research organisations. Each REC is made up from members of the general public as well as social care and healthcare professionals, who provide a voluntary service to protect the rights, dignity and safety of research participants by ensuring that these research projects conform to accepted ethical principles and standards.

The range of research involved included clinical trials of medicinal products or drugs, trials of medical devices or other interventions, as well as research involving vulnerable subjects such as patients /services users with learning difficulties, mental impairment, and ‘looked after’ children. The research involves social care and medical research using both quantitative and qualitative methods. The range of research is diverse and includes sponsorship from the HSC, from charities, commercial companies and universities.

This year in preparation for the implementation of the new EU clinical trials regulation or the alternative BREXIT, the service had been actively involved in a live pilot of Clinical trials using a new combined way of working with the MHRA (UK Medicines and Healthcare Products Regulatory Agency). This meant that 2 slots per committee were dedicated to review of one trial in the new way of working. This means that the overall workload for new studies reviewed at full committee is slightly lower than in previous years for this reason. However this was important to do preparedness work with the committees and the staff.

Of the new studies reviewed, 110 had significant material ethical issues (and were reviewed by a full REC) and 52 had less significant ethical issues (and were reviewed by a sub-committee of the full REC known as a Proportionate Review Sub-committee (PRSC)). In addition, the service considered a total of 175 substantial amendments to studies which have received ethical approval. The service also reviewed 74 safety reports, 1 serious adverse event, 236 annual progress reports and 128 final study reports for ongoing studies. The following tables give an overview of workload; timelines and Key performance indicators achieved by the service and shows service performance improvement year on year.

The decision types between HSC REC A and B were consistent and comparable.

The full individual annual reports for the RECs are enclosed.

Yours sincerely

Dr Siobhan McGrath (Head of the ORECNI) Directorate of Customer Care and Performance, BSO Date: 17th September 2019

Table 1 Comparison over last 7 financial years of timeline service improvement for different work-streams Financial Year

2010-11

2011-12

2012-13

2013-14

2014-15

2015-16

2016-7

2017-18

2018-19

New studies Full REC: KPI 95%

% meeting legal timeline 60 days

99.4 100 100 100 100 100 100 100 100

% meeting present KPI target 40 days or less

56 71.4 76.5 78 87.5 100 100 100 100

Amendments post approval KPI 95%

% meeting legal timeline 35 days

100 100 100 100 100 100 100 100 100

% meeting present KPI target 28 days or less

82.8 88 89.5 85.6 92.7 99.5 100 98.3 98.3

New studies by PRSC KPI 95%

% meeting UK KPI 14 days

None 100 100 93 90 100 99 100* 100*

KPI aim is 95% we have achieved this and more in all areas. *- national timeline for PRSC changed from 14 to 21 days in the financial year 2017-18

Table 2 Workload Comparison over last 8 financial years Year 2009-

10 2010-11

2011-12

2012-13

2014-15

2015-16

2016-17

2017-18

2018-19

Nos. of New studies

176 179 175 159 171 195 196 171 162

Nos. of Substantial Amendments

182 159 182 114 151 168 195 183 175

Research Ethics Service

HSC REC A

Annual Report

01 April 2018 - 31 March 2019

HSC REC A Annual Report – 01.04.2018 – 31.03.2019

Part 1 – Committee Membership and Training Name of REC: HSC REC A Type of REC: Recognised, Type 1 and 3 Type of Flag: Phase 1, RTBs, ALC (NI only), Medical Devices, Qualitative,

Devices, Paediatrics Chair: Dr Alastair Walker Vice-Chair: Dr Mary Murphy Alternate Vice-Chair: Mr Barry Mimnagh REC Manager: Ms Tamla Meredith REC Assistant: Mrs Lorna Callaghan & Ms Katie Arnold Committee Address: Business Services Organisation

Unit 5, Lissue Industrial Estate West Rathdown Walk, Moira Road Lisburn BT28 2RF

Telephone: 02895 361400 Email: [email protected]


Chair’s overview of the past year: I am delighted to report on another successful year for HSC REC A from 1 April 2018 to 31 March 2019. The professionalism of the volunteer committee members supported by ORECNI staff has enabled us again to deliver on 100% of the KPIs, exceeding many of the targets in the process. Much of the credit must go to REC A Manager, Tamla Ervine (formerly Meredith), whose high standards of knowledge and skills have provided the Committee with outstanding support. During the year our Chair, Dr Catherine Hack resigned through pressure of work. She was replaced by the Acting Chair, Dr Alastair Walker, ably supported by Vice Chair Dr Mary Murphy and Alternate Vice-Chair Barry Mimnagh. We have also been joined by a number of new recruits who have settled into their role very quickly and are making valuable contributions to the Committee’s deliberations. We are again pleased to have received positive feedback from many of the researchers with whom we have worked and it is good to know that our role is valued as being a positive one in ensuring the highest quality of research in health and social care. During the year, the Committee took part in a pilot of a new procedure for the approval of early phase drug trials. The pilot showed that the new process was helpful to researchers by combining applications for ethical and Medicines and Healthcare products Regulatory Agency (MHRA) approval into a single procedure. This has now been rolled out operationally. The annual training day was held in March 2018 with a high attendance by members. Other training opportunities continue to be made available to ensure that the knowledge and skills required to undertake the ethics reviews are kept up to date.


HSC REC A Membership

HSC REC A: Deputy Members

HSC REC A: Co-opted Members from REC B

Name Profession Expert or

Lay Dates

Appointed Left Mrs Adele Boyd Independent Practice

Educator Lay 05/06/2017 03/08/2018

Ms Margaret Brady Deputy Chief Education Welfare Officer Operations

Lay Plus 17/02/2014

Mr James Cooke Student Lay Plus 01/07/2019 Ms Marie Fenton Guardian Ad Litem, Social

Worker Lay 01/03/2018

Dr Catherine Hack Consultant in Academic Practice (STEM)

Lay Plus 17/02/2014 07/09/2018

Dr Helen Harty Academic Lecturer Lay 18/02/2014 Mrs Julie Howse Barrister (non practising) Lay 01/03/2018 Ms Rosemary Kelly Registered Nurse Expert 01/07/2019 Dr Lorna Lawther Registered Midwife Expert 01/03/2018 Mrs Kathryn Logue Barrister In Independent

Practice Lay Plus 01/03/2018

Mr Godfrey Madill Project Manager Lay Plus 05/06/2017 Ms Rejina Mariam Verghis Junior Biostatistician Expert 17/01/2017 Dr Toni McAloon Nurse Lecturer Expert 17/02/2014 Mr Niall McSperrin Solicitor Lay Plus 17/02/2014 07/02/2019 Mr Barry Mimnagh Pharmacist Expert 17/01/2017 Dr Andrew Moriarty Cardiologist Expert 01/03/2018 Dr Charles Mullan Consultant Radiologist Expert 17/02/2014 Dr Mary Murphy Registered Nurse Expert 18/02/2014 Mr Patrick Ryan Retired Civil Servant Lay Plus 05/06/2017 Professor Mahendra Varma

Consultant Physician in charge of Cardiology and Diabetic Services (Retired)

Expert 17/02/2014

Dr Alastair Walker Retired Head of Education Services, CCEA

Lay Plus 17/02/2014

Name Profession Status Meeting date attended Dr Andrew Moriarty Cardiologist Expert 24/04/2018 Dr Andrew Moriarty Cardiologist Expert 29/05/2018 Dr Andrew Moriarty Cardiologist Expert 26/06/2018 Dr Andrew Moriarty Cardiologist Expert 25/09/2018 Dr Andrew Moriarty Cardiologist Expert 30/10/2018 Dr Andrew Moriarty Cardiologist Expert 27/11/2018 Dr Andrew Moriarty Cardiologist Expert 18/12/2018


Name Profession Status Meeting date attended Ms Mary McMahon Director Lay 29/01/2019 Dr Elinor Johnston Research Assistant

(Clinical Studies Coordinator)

Expert 26/02/2019


HSC REC A: Members’ Declarations of Interest:

Name Declaration of Interest Date Ms Marie Fenton May have a connection to NIGALA. See

Documents tab for signed, scanned form. 05/03/2019

Dr Lorna Lawther Lecturer at Queens University Belfast. See Documents tab for signed, scanned form.

05/03/2019

Mrs Kathryn Logue Sister Jacqueline Jamison is a consultant in laboratory medicine at Antrim Area Hospital (Cytopathology) and therefore if any research involving this came before the committee, Kathryn would exclude herself.

05/03/2019

Dr Toni McAloon None. See Documents tab for signed, scanned form.

05/03/2019

Mr Barry Mimnagh Member of Council of The Pharmaceutical Society of N.I. Possible relevance to pharmacy (not pharma) applications. (NHS/Uni) Will declare and withdraw if potential conflict. See Documents tab for signed, scanned form.

05/03/2019

Dr Charles Mullan None, although there are a list of activities or interest likely or possibly likely to be related to the conduct of research: Divisional Clinical Director Cancer Services + Diagnostics Western Health and Social Care Trust See Documents tab for signed, scanned form.

05/03/2019

Professor Mahendra Varma Chairman of Governance Board N.I Chest, Heart and Stroke. See Documents tab for signed, scanned form

05/03/2019

Dr Alastair Walker None. See Documents tab for signed, scanned form.

05/03/2019

Dr Andrew Moriarty Member of Research Governance Committee, R&D Office, Southern Health and Social Trust.

05/03/2018


Meetings for Full Ethical Review 01 April 2018 - 31 March 2019:

Proportionate Review Sub-Committee Meetings held during 01 April 2018 - 31 March 2019:

Sub-Committee Meetings held during 01 April 2018 - 31 March 2019:

Month Date Number of Members Present at Meeting

April 24/04/2018 10 May 29/05/2018 12 June 26/06/2018 10 August 21/08/2018 10 September 25/09/2018 11 October 30/10/2018 10 November 27/11/2018 10 December 18/12/2018 8 January 29/01/2019 8 February 26/02/2019 9 March 26/03/2019 9 11 full committee meetings were held during the reporting period.


April 09/04/2018 3 May 08/05/2018 3 June 04/06/2018 3 August 13/08/2018 3 September 10/09/2018 3 October 08/10/2018 3 December 03/12/2018 4 January 14/01/2019 3 February 11/02/2019 3 March 11/03/2019 3 10 proportionate review sub-committee meetings were held during the reporting period.


April 20/04/2018 2 April 30/04/2018 2 May 15/05/2018 2 June 06/06/2018 2 July 02/07/2018 2 July 26/07/2018 2 August 20/08/2018 2 September 07/09/2018 2 September 26/09/2018 2 October 17/10/2018 2


Details of inquorate meeting held:01 April 2018 - 31 March 2019

November 08/11/2018 2 November 30/11/2018 2 December 03/12/2018 2 December 19/12/2018 2 January 14/01/2019 2 January 21/01/2019 2 February 08/02/2019 2 February 28/02/2019 2 March 18/03/2019 2 March 22/03/2019 2 20 sub-committee meetings were held during the reporting period. Date Reason Action taken


Attendance of Members at full committee meetings:01 April 2018 - 31 March 2019

Attendance of Members at proportionate review sub-committee meetings: 01 April 2018 - 31 March 2019

Attendance of Members at sub-committee meetings: 01 April 2018 - 31 March 2019

Name Number of

Meetings Attended

Mrs Adele Boyd 1 Ms Margaret Brady 4 Ms Marie Fenton 6 Dr Catherine Hack 2 Dr Helen Harty 8 Mrs Julie Howse 2 Dr Elinor Johnston 1 Dr Lorna Lawther 6 Mrs Kathryn Logue 7 Mr Godfrey Madill 9 Ms Rejina Mariam Verghis 4 Dr Toni McAloon 4 Ms Mary McMahon 1 Mr Niall McSperrin 4 Mr Barry Mimnagh 9 Dr Andrew Moriarty 8 Dr Charles Mullan 6 Dr Mary Murphy 9 Professor Mahendra Varma 6 Dr Alastair Walker 10

Name Number of

Meetings Attended

Mrs Adele Boyd 2 Ms Margaret Brady 5 Dr Helen Harty 3 Ms Rejina Mariam Verghis 4 Dr Toni McAloon 2 Mr Barry Mimnagh 3 Dr Charles Mullan 5 Dr Mary Murphy 3 Dr Alastair Walker 4 Name Number of

Meetings Attended

Ms Margaret Brady 1 Ms Rejina Mariam Verghis 1


Dr Toni McAloon 4 Mr Barry Mimnagh 8 Dr Charles Mullan 4 Dr Mary Murphy 7 Dr Alastair Walker 15


Training 01 April 2018 - 31 March 2019

Name of Member Date Event(s) attended Ms Marie Fenton 05/03/2019 HSC REC Training Day 5th

March 2019 Mrs Julie Howse 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Lorna Lawther 05/03/2019 HSC REC Training Day 5th

March 2019 Mrs Kathryn Logue 05/03/2019 HSC REC Training Day 5th

March 2019 Mr Godfrey Madill 11/09/2018 Medical Devices Mr Godfrey Madill 12/09/2018 Annual Training Day Papers

6.3.2018 Dr Toni McAloon 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Toni McAloon 13/03/2019 REC Annual Training Day

5.3.2019 Pack Mr Barry Mimnagh 06/11/2018 New REC Chairs Mr Barry Mimnagh 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Andrew Moriarty 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Charles Mullan 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Mary Murphy 10/05/2018 Training for New REC Chairs Professor Mahendra Varma 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Alastair Walker 05/12/2018 National Chairs Training Day Dr Alastair Walker 05/03/2019 HSC REC Training Day 5th

March 2019


PART 2: REC WORKLOAD AND ACTIVITY DURING THE REPORTING PERIOD

Table 1: Applications assigned to a full committee meeting held within the reporting period:

Table 2: Breakdown of full applications and other activity during reporting period

Table 3: Decisions given at meetings held within the reporting period

Applications for full ethical review – Study Type Number % Clinical Trial of Investigational Medicinal Product 8 14.81 Phase 1 12 22.22 Gene Therapy 0 0.00 Research Tissue Bank (including renewals) 0 0.00 Research Database (including renewals) 0 0.00 Others 34 62.96 Total Applications Reviewed 54 100

Number of applications made invalid by the REC Manager 0 Number of applications withdrawn prior to the meeting 7 Number of student applications reviewed 12 Number of paediatric applications reviewed 0 Number of device applications reviewed 3 Number of prisoner applications reviewed 1 Number of applications involving adults unable consent reviewed 3 Number of applications reviewed that are funded by the US DHHS 0 Number of qualitative applications reviewed 6

Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 4 7.41 Favourable Opinion with Additional Conditions 7 12.96 Unfavourable Opinion 4 7.41 Provisional Opinion 39 72.22 Provisional Opinion Pending Consultation with Referee 0 0.00 Total 54 100 Number of studies sent back to full committee meeting for final opinion

0


Table 4: Summary of current status of applications reviewed during the reporting period

Status of applications at date of generation of report Number % Further Information Favourable Opinion with Standard Conditions

33 61.11

Further Information Favourable Opinion with Additional Conditions

4 7.41

Further Information Unfavourable Opinion 0 0.00 Favourable Opinion with Standard Conditions 4 7.41 Favourable Opinion with Additional Conditions 7 12.96 Unfavourable Opinion 4 7.41 Provisional Opinion 0 0.00 Provisional Opinion Pending Consultation with Referee 0 0.00 Further Information response not complete 0 0.00 No decision entered on system 0 0.00 Number of studies withdrawn after the meeting 2 3.70 Total 54 100


Table 5: Applications assigned to a proportionate review sub-committee within the reporting period

Table 7: Decisions given at proportionate review sub-committee meetings held within the reporting period

Table 6: Breakdown of PRS applications and other activity during reporting period:

Number of applications made invalid by the REC Manager 3 Number of studies withdrawn prior to the meeting 3 Number of student applications reviewed 8 Number of paediatric applications reviewed 2 Number of device applications reviewed 3 Number of qualitative applications reviewed 1

Total Applications Reviewed 25

Decisions taken at proportionate review sub-committee meetings

Number %

Favourable Opinion with Standard Conditions 4 16.00 Favourable Opinion with Additional Conditions 4 16.00 No Opinion transfer to full committee for review 1 4.00 Provisional Opinion 15 60.00 Unfavourable Opinion 1 4.00 Total 25 100


Table 8: Other Management Information based on the number of completed applications for th ti i d Average number of applications reviewed per full meeting 4.91 Number of completed applications for full ethical review 52 Number of completed applications for full ethical review over 60 days

0

Number of completed applications over 60 days as a % of total

0.00%

Number of completed applications for full ethical review over 40 days

0


0.00%

Number of days taken to final decision – average (mean) 24 Number of completed proportionate review applications for ethical review

24

Number of completed proportionate review applications for ethical review over 21 days

0

Number of completed proportionate review applications over 21 days as a % of total

0.00%

Number of SSAs (non-Phase 1) reviewed 4 Number of completed applications for SSA review over 25 days

0

Number of completed applications for SSA review over 25 days as % of all non- Phase 1 SSAs

0.00%

Number of SSAs (Phase 1) reviewed 16 Number of completed applications for SSA review over 14 days

0

Number of completed applications for SSA review over 14 days as % of all Phase 1 SSAs

0.00%

Number of substantial amendments reviewed 94 Number of completed substantial amendments over 35 days 0 Number of completed substantial amendments over 35 days as a % of total substantial amendments

0.00%

Number of completed substantial amendments over 28 days 1 Number of completed substantial amendments over 28 days as a % of total substantial amendments

1.06%

Number of modified amendments reviewed 0 Number of completed modified amendments over 14 days 0 Number of completed modified amendments over 14 days as a % of total modified amendments

0.00%

Number of non substantial amendments received 66 Number of substantial amendments received for information 1 Number of substantial amendments received for new sites/PIs

15

Number of annual progress reports received 110


Number of safety reports received 32 Number of Serious Adverse Events received 0 Number of final reports received 51

HSC REC A Research Ethics Committee Annual Report

Table 9.1: Breakdown of current status of all full applications reviewed within the reporting period Further Information Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0066 Assessment of the safety, tolerability and immunogenicity of MV-CHIK 23 18/NI/0070 WOUNDCHEK Bacterial Status Benefits Evaluation 23 18/NI/0076 DeMIE: Determining Medicine-related Issues for people with Epilepsy 24 18/NI/0088 Pharmacology study of GLPG3067- Pro/combination in healthy females 27 18/NI/0089 Improving pain management for patients with dementia in acute care 25 18/NI/0090 Relationships & Future Fatherhood (1) 25 18/NI/0098 WeReha - Magic PCP 30 18/NI/0110 Evaluating the 'Just US' Programme 24 18/NI/0114 Vitamin D status and bone health of older adults in care facilities 24 18/NI/0117 Optometric versus ophthalmic follow up of cataract surgery in N.I 27 18/NI/0118 ADME Study of [14C]-APX001 in Healthy Male Subjects (QSC117978) 23 18/NI/0140 CT-P17 – first doses in humans & comparison with Humira; v1 26 18/NI/0141 Co-producing and Implementing Person-centredness in CAncer Nursing 26 18/NI/0150 Women's perceptions of CBT delivered by health visitor 27 18/NI/0156 Service User Opinions of 3D Breast Images as Decision-making Aids 25 18/NI/0157 Phase 1 Pharmacokinetic Study in Healthy Male Volunteers (QSC118052) 21 18/NI/0174 Unravelling patient predictors of ex vivo stem cell expansion 25 18/NI/0184 Prehabilitation for being active. A feasibility study in fibromyalgia 23 18/NI/0191 MedEx-UK: Mediterranean diet, exercise and dementia risk in UK adults 27 18/NI/0194 A study comparing the effects of Trimbow to Fostair in COPD 34 18/NI/0195 Study of Cobomarsen(MRG-106) vs Active Comparator in Mycosis Fungoides 30 18/NI/0209 Safety, Tolerability and PK of Single and Multiple Doses of MT-6345 24 18/NI/0211 Improving engagement with Cardiac Rehabilitation 26 18/NI/0213 Effect of a CR programme on Molecular Mechanisms. Version 4. 23 18/NI/0234 FlexNav EU CE Mark Study 25 18/NI/0235 Phase 1 bioavailability study in healthy subjects (QSC118018) 20 18/NI/0236 The SPRING Study 28 18/NI/0240 PICO7Y Negative Pressure Wound Therapy system- CT1704P7Y 19 19/NI/0004 Safety, blood levels and effects of rozanolixizumab v1 24 19/NI/0011 BRAIN-Diabetes: Version 1 24 19/NI/0032 Study of safety and efficacy of Betalutin & rituximab in pts with FL 28 19/NI/0034 Biomarker analysis using fresh biopsy samples 25


19/NI/0049 Adjunctive NaBen treatment of schizophrenia in adults 21

Further Information Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0100 Medicines management intervention in people with dementia (V2) 23 19/NI/0007 Melatonin and chronic pain (DREAM-CP) V1 31 19/NI/0013 Stakeholders priorities for social functioning in schizophrenia 25 19/NI/0054 Creative Masters of Research Project at the NI Hospice 38

Further Information Unfavourable Opinion REC Reference Title Number of Days on Clock

Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0116 Single and repeat doses of RVT-1201 in healthy subjects (QSC200305) 25 18/NI/0139 Phase 1 ADME study of valproate in healthy females (QSC118091) 22 19/NI/0008 Immune responses to KLH, Tetanus toxoid, Shingrix and Zostavax 21 19/NI/0036 Effect of CORT118335 on Olanzapine-Induced Weight Gain (QSC202012) 18

Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0074 Implementation and Evaluation of Constipation Educational Intervention 21 18/NI/0158 A first-in-human study of a novel HPV vaccine in healthy subjects 22 18/NI/0167 Investigation of summation under conditions of microperimetry in AMD 22 18/NI/0208 Phase 1 PK and PD study of SEP-4199 in healthy subjects (QSC200830) 20 18/NI/0228 Postnatal lifestyle intervention in women with previous GDM-2 17 18/NI/0233 STIFLE 20 19/NI/0056 Palatability Assessment of Ivosidenib in Healthy Adults (QSC201688) 17

Unfavourable Opinion REC Reference Title Number of Days on Clock


Table 9.2: Breakdown of current status of all PRS applications reviewed within the reporting period

18/NI/0069 Medicines management intervention in people with dementia (V1) 21 18/NI/0146 BBV_TestPrompt: testing a CDS system for prompted BBV testing 22 18/NI/0166 Effect of a CRP on Molecular Mechanisms. Version 3. 22 19/NI/0038 Disentangling Emotional Processing from Regulation in Bulimia Nervosa 22

Provisional Opinion REC Reference Title Number of Days on Clock

Provisional Opinion Pending Consultation with Referee REC Reference Title Number of Days on Clock

Further information response not complete REC Reference Title Number of Days on Clock

Withdrawn after the meeting REC Reference Title Number of Days on Clock 18/NI/0097 MAGIC EU Stroke Rehab: Moovr Mass VR Game v2.0 21 19/NI/0015 Patients preferences for rectal cancer treatment 25

Further Information Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0092 Early Colonisation of Tracheostomy Tubes 10 18/NI/0093 Monitoring cognitive health using the BrainWaveBank platform, v1.1 14 18/NI/0111 Dental Digital Bitewing Radiograph Study 12 18/NI/0112 Microbial analysis of excess sputum samples 13 18/NI/0113 Tumour Heterogeneity: Unravelled Molecular Patterns (THUMP) 13 18/NI/0147 Assessment of the MACPT tool to facilitate communication 9


18/NI/0149 SONG-PKD 9 19/NI/0009 Peripheral nerve stimulation for Tremor 14 19/NI/0030 DMI Study 12 19/NI/0031 Patellofemoral dislocation in Charcot Marie Tooth disease 13 19/NI/0033 Prehabilitation of cancer patients before major abdominal surgery 7 19/NI/0066 iCBT for depression in axial spondyloarthritis 10 19/NI/0067 Movement Learning in Children who Stammer 10

Further Information Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0072 Switching antipsychotics – a qualitative study 7 18/NI/0189 TARGET FAL01 - version 1 13


Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0094 Frailty and sarcopenia outcomes in emergency general surgery 8 18/NI/0148 Extraction of circulating nucleic acids from human blood from SNBTS 7 18/NI/0170 Investigation of human adenovirus in paediatric haematology patients 7 19/NI/0010 Can mtDNA mutations predict chemoradiotherapy response in rectal cance 6

Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0073 Syntaxin Phosphorylation in human adipose tissue 6 18/NI/0171 A RCT of a digital CBT app for smoking cessation v1 8 18/NI/0188 LUM0001 7 18/NI/0227 Very Late Recurrence in ER+ Breast Cancer 7

Unfavourable Opinion


REC Reference Title Number of Days on Clock 18/NI/0071 Feasibility study on healthy volunteers on Gaming Effects 6



Withdrawn after the meeting REC Reference Title Number of Days on Clock


Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting period Favourable opinion Amendment REC Reference

Title Version Date Number of Days on Clock

06/NIR01/141/AM07 Genetic variation in biological pathways & oesophageal adenocarcinoma

version 7, 7.08.2018

29/08/2018 11

13/NI/0160/AM12 MANAGE Trial 29/04/2018 13 13/NI/0160/AM13 MANAGE Trial Substantial

Amendment 5 - upda

29/04/2018 13

14/NI/1149/AM06 Mirror box therapy with stroke patients Substantial Amendment No

001 3

04/09/2018 16

14/NI/1149/AM07 Mirror box therapy with stroke patients Substantial Amendment 002 12

N

02/12/2018 16

15/NI/0074/AM08 ADRRAD 21/09/2018 19 15/NI/0127/AM17 Open-label Extension Study of ALN-AT3SC in Haemophilia

Patients EC SA10: Sponsor

Change –Step 20/07/2018 11

15/NI/0127/AM18 Open-label Extension Study of ALN-AT3SC in Haemophilia Patients

SA11 Protocol Amendment 5

15/01/2019 27

15/NI/0127/AM19 Open-label Extension Study of ALN-AT3SC in Haemophilia Patients

SA12 ICF Addendum

18/02/2019 29

15/NI/0145/AM13 GO29365 - Phase Ib/II Study of Polatuzumab Vedotin in r/r FL or DLBCL

SA13 12/11/2018 23

15/NI/0145/AM15 GO29365 - Phase Ib/II Study of Polatuzumab Vedotin in r/r FL or DLBCL

Substantial Amendment 15

20/12/2018 22

15/NI/0161/AM15 EASI-SWITCH v1.0 Substantial Amendment #14

23/03/2018 24

15/NI/0161/AM20 EASI-SWITCH v1.0 Amendment 16 26.6.2018

16/08/2018 25

15/NI/0170/AM06 Retrospective study to describe the real world UK use of TKIs in CML

Substantial Amendment #3

30/07/2018 22

16/NI/0098/AM05 GLJ576-P001 Saftey and Efficacy of SIMBRINZA BID V1.0 SA4 28/06/2018 5 16/NI/0106/AM04 Effect of e-cigarettes on human lung inflammation and blood Amendment no 4 03/07/2018 21


vessels 16/NI/0174/AM05 CTD-TCNPC-201 Phase I/II study of Intravenous Trappsol

Cyclo in NPC-1 Substantial

Amendment 2 18/05/2018 21

16/NI/0174/AM09 CTD-TCNPC-201 Phase I/II study of Intravenous Trappsol Cyclo in NPC-1

CTD-TCNPC-201 Protocol Amendme

18/09/2018 6

16/NI/0195/AM01 Magnetoencephalography in Alzheimer's Disease 1 (Substantial Amendment 1), 0

08/10/2018 8

16/NI/0224/AM04 Oral Rehabilitation with Dietary Intervention for Older Patients in NI

Substantial Amendment 4.0

(21.

22/01/2019 20

16/NI/0233/AM03 Establishing a phenotype for cachexia in chronic kidney disease

4 (SA2) 07/11/18 08/11/2018 22

16/NI/0242/AM04 Mobile-EEG based profiling of Mild Cognitive Impairment 4.0 18 April 2018 18/04/2018 27 17/NI/0005/AM03 A Phase I trial of LY3143921 hydrate in solid tumours 20/04/2018 20 17/NI/0005/AM04 A Phase I trial of LY3143921 hydrate in solid tumours 24/01/2019 9 17/NI/0031/AM01 SPEAR Substantial

Amendment 1 16.7.2

20/07/2018 11

17/NI/0048/AM02 CORT125281 – first dose in humans; version 1 Substantial Amendment 2,

proto

29/03/2018 24

17/NI/0051/AM03 A Cross-sectional Study to Measure Cough in Severe Asthma Amendment 3 13/12/2018

13/12/2018 7

17/NI/0091/AM04 Flare-ups in Knee Osteoarthritis: An Interview Study 2 6.11.2018 21/11/2018 9 17/NI/0095/AM03 Study of the analytical performance of ALLEGROâ„¢

instrument V5_20180309 10/05/2018 27

17/NI/0096/AM07 HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness SA#05 29/05/2018 9 17/NI/0096/AM10 HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness Sponsor EU Legal

Representativ 28/02/2019 25

17/NI/0106/AM04 HTL0016878 – first doses in humans: version A Substantial Protocol

Amendment

04/05/2018 9

17/NI/0106/AM05 HTL0016878 – first doses in humans: version A Substantial protocol

amendment

17/08/2018 24

17/NI/0115/AM10 (duplicate) PhysicalFnAfterICU 05/10/2018 13


17/NI/0148/AM04 Optimal choice of targeted therapies in inflammatory bowel disease


25/04/2018 19

17/NI/0148/AM07 Optimal choice of targeted therapies in inflammatory bowel disease

03/09/2018 23

17/NI/0154/AM02 Sensor Technology to Assses Overnight Care Needs in Care Homes v1.0

v4, 27/06/2018 05/07/2018 27

17/NI/0190/AM01 A protocol to facilitate the collection of blood samples for research

10/06/2018 5

17/NI/0204/AM01 OCTOBER study (v3.0) Number 1 15/05/2017

26/06/2018 13

17/NI/0205/AM02 SAD, Food Effect and MAD study of GDC-0334 (QCL117876) SA02 (Temporary Halt)

17/07/2018 14

17/NI/0205/AM03 SAD, Food Effect and MAD study of GDC-0334 (QCL117876) SA03 (Trial Restart)

17/10/2018 17

17/NI/0209/AM02 STRATA 2, version 1 Amendment 1, 9 May 2018

14/05/2018 25

17/NI/0209/AM03 STRATA 2, version 1 Amendment 2, 14 November 2018

30/11/2018 20

17/NI/0210/AM01 Elastography of the Achilles tendon in gout 1.0 Substantial Amendment 1

23/01/2019 20

17/NI/0212/AM01 Differential proliferative activity in melanoma 05/04/2018 17 17/NI/0224/AM06 PK/PD Study - Effect of OBE2109 and Concurrent or Delayed

Add-Back on Substantial

Amendment 2: IB, V

20/04/2018 26

17/NI/0230/AM14 Study to assess the safety, tolerability & PK of PTI-808/801/428 in CF


05/06/2018 27


20180824_PTI808-02_SubStant_Am

24/08/2018 10


20181122_PTI-808-

02_SubAmend#6

22/11/2018 7

17/NI/0234/AM01 Evaluating interventions for informed consent for surgery 22/11/2018 23 17/NI/0235/AM01 The MONARCH study SA001 11/05/2018 27 17/NI/0235/AM02 The MONARCH study SubAmend 002,

24 Aug2018 24/08/2018 18


17/NI/0236/AM07 Support Needs After Critical care (SNAC) 1, 05/07/2018 06/07/2018 25 17/NI/0239/AM01 JNJ-64417184 – first doses in humans; v2 (17-015) Substantial

Amendment 1 - Prot

06/04/2018 14

17/NI/0239/AM02 JNJ-64417184 – first doses in humans; v2 (17-015) Substanital Amendment 2,

Proto

24/08/2018 14

17/NI/0239/AM03 JNJ-64417184 – first doses in humans; v2 (17-015) Substantial Amendment 3,

Proto

18/10/2018 20

17/NI/0239/AM04 JNJ-64417184 – first doses in humans; v2 (17-015) Protocol Amendment 6

21/12/2018 22

17/NI/0239/AM05 JNJ-64417184 – first doses in humans; v2 (17-015) Protocol Amendment 7

28/02/2019 15

18/NI/0010/AM01 Feasibility Attention Control Training amongst very preterm infants V2

n1 16.08.2018 17/08/2018 23

18/NI/0010/AM02 Feasibility Attention Control Training amongst very preterm infants V2

Substantial Amendment n2

20/11/2018 9

18/NI/0011/AM03 FORWARD PRO Study Amendment no 1 - 12 July 2018

16/07/2018 15

18/NI/0012/AM01 HV Study to Assess Normal Range of C4 and C1-INH (QCL118059)

03/08/2018 18

18/NI/0013/AM01 Advanced cardiovascular imaging in pregnancy 15/10/2018 24 18/NI/0013/AM02 Advanced cardiovascular imaging in pregnancy 13/03/2019 12 18/NI/0039/AM01 A Phase 1 Study of ORIC-101 in Healthy Adults (QCL118164) 19/04/2018 6 18/NI/0039/AM03 A Phase 1 Study of ORIC-101 in Healthy Adults (QCL118164) SA02 (MHRA and

Ethics) 10/05/2018 7

18/NI/0054/AM01 Safety, Tolerability and PK of BDM-2 in Healthy Subjects (QCL118184)

SA01 17/04/2018 6

18/NI/0058/AM01 ARCANGEL STUDY v1.0 1 - Oct 31th 2018 31/10/2018 13 18/NI/0058/AM02 ARCANGEL STUDY v1.0 2 - Dec 13th 2018 13/12/2018 6 18/NI/0060/AM03 A Phase 2 safety and efficacy study of Lenabasum in Cystic

Fibrosis JBT101-CF-002 03/10/2018 15

18/NI/0066/AM01 Assessment of the safety, tolerability and immunogenicity of MV-CHIK

Substantial Amendment

6.7.2018

20/07/2018 11


18/NI/0066/AM02 Assessment of the safety, tolerability and immunogenicity of MV-CHIK

MV-CHIK-2015 8.8.2018

09/08/2018 7

18/NI/0072/AM01 Switching antipsychotics – a qualitative study 11/09/2018 23 18/NI/0073/AM01 Syntaxin Phosphorylation in human adipose tissue 30/11/2018 17 18/NI/0074/AM01 Implementation and Evaluation of Constipation Educational

Intervention 01/08/2018 18

18/NI/0074/AM02 Implementation and Evaluation of Constipation Educational Intervention

01/02/2019 10

18/NI/0088/AM01 Pharmacology study of GLPG3067- Pro/combination in healthy females

IB Addendum 1.00 #SA01

11/02/2019 10

18/NI/0093/AM01 Monitoring cognitive health using the BrainWaveBank platform, v1.1

13/08/2018 8


10/10/2018 8


04/02/2019 22

18/NI/0094/AM01 Frailty and sarcopenia outcomes in emergency general surgery Substantial Amendment 1

15/11/2018 23

18/NI/0098/AM01 WeReha - Magic PCP Amendment number 1, 26/11/2018

26/11/2018 8

18/NI/0100/AM01 Medicines management intervention in people with dementia (V2)

1,28.8.2018 29/08/2018 14

18/NI/0116/AM01 Single and repeat doses of RVT-1201 in healthy subjects (QSC200305)

SA01 16.8.2018 16/08/2018 24

18/NI/0141/AM01 Co-producing and Implementing Person-centredness in CAncer Nursing

Number:1Í¾ Date 26/09/2018

27/09/2018 16

18/NI/0167/AM01 Investigation of summation under conditions of microperimetry in AMD


20/02/2019 8

18/NI/0174/AM01 Unravelling patient predictors of ex vivo stem cell expansion Substantial Amendment 1

04/03/2019 22

18/NI/0188/AM01 LUM0001 Substantial Amendment No.01,

d

04/01/2019 11

18/NI/0191/AM01 MedEx-UK: Mediterranean diet, exercise and dementia risk in UK adults

Amendment 1: 08/01/19

08/01/2019 7


Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period



25/01/2019 21


Amendment 3: 24/01/2019

29/01/2019 17


Amendment 4: 30/01/2019

30/01/2019 14

18/NI/0195/AM01 Study of Cobomarsen(MRG-106) vs Active Comparator in Mycosis Fungoides

SA -001 14/03/2019 15

18/NI/0234/AM01 FlexNav EU CE Mark Study Substantial Amendment 001 -

Fe

19/02/2019 9

Unfavourable opinion Amendment REC Reference


Favourable opinion timeline Amendment REC Reference


Unfavourable opinion timeline Amendment REC Reference



Table 11: Items exceeding timelines Full applications for ethical review over 60 day timeline REC Reference Title Number of Days on Clock

Proportionate review applications for ethical review over 21 day timeline REC Reference Title Number of Days on Clock

SSAs (non Phase 1) over 25 day timeline REC Reference Title Number of Days on Clock

SSAs (Phase 1) over 14 day timeline REC Reference Title Number of Days on Clock

Substantial Amendments over 35 day timeline Amendment REC Reference


Modified Amendments over 14 day timeline Amendment REC Reference


Research Ethics Service

HSC REC B

Annual Report

01 April 2018 - 31 March 2019

HSC REC B Annual Report – 01.04.2018 – 31.03.2019

Part 1 – Committee Membership and Training Name of REC: HSC REC B Type of REC: Recognised, Type 1 and 3

Type of Flag: Phase 1, Research Databases, ALC (NI only), Medical Devices,

Qualitative, Paediatrics

Chair: Professor Patrick Murphy Vice-Chair: Dr Anne Moorhead Alternate Vice-Chair: Ms Sue Trouton REC Manager: Mrs Denise Nesbitt

Mrs Melissa Stewart (PRS) REC Assistant: Mrs Lorna Callaghan & Ms Katie Arnold Committee Address: Business Services Organisation

Unit 5, Lissue Industrial Estate West Rathdown Walk, Moira Road Lisburn BT28 2RF

Telephone: 02895 361408 Email: [email protected]


Chair’s overview of the past year: The success of any committee depends on the ability, attitude and values of its members. In REC B we are fortunate to have such a wide range of individuals who have a remarkably high level of competence, both personal and professional, which comes together in a spirit of co-operation and dedication to produce a decision-making process which is effective, ethical and appreciated. But it takes more than ability to make a committee work. The members of REC B have developed an attitude of going the extra mile in seeking to fully appreciate the vast array of scientific, medical and social knowledge, which is necessary to evaluate the ethics and efficacy of all the applications which come before them. For a group of people who work on a voluntary basis, this represents a degree of commitment not normally seen in much of modern society. But although their abilities and attitudes shape that commitment, it is their values which add quality to their decision-making on the ethics of research applications. By being individually and collectively fair and equitable in evaluating often complex information and concepts, they produce reasoned and logical outcomes which protect the interests of patients and wider society. At the same time they do all they can to facilitate and encourage scientific, medical and social research in a manner which allows the efficient and effective processing of applications. None of this would be possible without the help and co-operation of a highly dedicated team of staff in the Office of Research Ethics Northern Ireland. Their courtesy, professionalism and overall support ensure the smooth running of what is often a complex process. Of course, this does not mean that we in REC B can rest on our laurels. In an ever-changing world, we recognise that we must constantly strive to improve the quality of our service, because society's progress depends on new knowledge and understanding, which in turn depend on ethical research. Fortunately REC B has the members to strive for, and achieve, that continuous improvement.


HSC REC B Membership

HSC REC B: Co-opted Members

Name Profession Expert or

Lay Dates

Appointed Left Dr Ronald Atkinson Retired Consultant in

Medical Oncology Expert 01/04/2015

Dr Aaron Courtenay Pharmacist Expert 01/03/2019 Mr Martin John Fisher Irish League of Credit

Unions Lay Plus 05/06/2017

Miss Natalie Hayes Legal Support Worker Lay Plus 01/03/2018 17/05/2019 Dr Elinor Johnston Research Assistant

(Clinical Studies Coordinator)

Expert 01/04/2015

Dr Donna Kernaghan Research & Policy Officer Lay 01/07/2019 Dr Justin Magee Senior Lecturer in Design

Education Lay 01/02/2017 06/12/2018

Mrs Cliona McDowell Statistician Expert 17/02/2014 Ms Mary McMahon Director Lay 12/06/2017 Mrs Evelyn Melanophy Solicitor Lay Plus 01/07/2019 Dr Kristel Miller Senior Lecturer

Leadership Marketing and Strategy

Lay Plus 01/03/2018

Mr John Edward Mone Retired (Former Executive Director of Nursing)

Lay 17/02/2014

Dr Anne Moorhead Senior Lecturer in Health & Communication

Lay 17/02/2014

Ms Aine Morrison Service Manager, Community Treatment & Support Services for Learning Disability

Lay 17/02/2014

Professor Patrick Murphy Advisor on Social & Economic Policy

Lay Plus 17/02/2014

Dr Seamus O'Brien Outcomes Manager, Primary Joint Unit

Expert 17/02/2014

Mr Leon O'Hagan Pharmacist Expert 01/01/2015 06/06/2019 Mr Glenn Phair Health Economist Lay 01/07/2019 Dr Mark Reid Retired Consultant

Paediatrician Expert 01/04/2015

Ms Marilyn Trimble Lecturer in Law and Ethics and Business Law

Lay Plus 17/02/2014

Ms Sue Trouton Community Midwifery Sister

Expert 17/02/2014

Dr Lisa Watt Speciality Physician- Care of the Elderly

Expert 01/03/2018 15/04/2019

Name Profession Status Meeting date attended Mr Barry Mimnagh Pharmacist Expert 25 March 2019 PRS


HSC REC B: Members’ Declarations of Interest:

Name Declaration of Interest Date Dr Aaron Courtenay Volunteer as a STEM ambassador. Volunteer

mentor with the Social mobility foundation Member of the Royal Society of Chemistry. Fellow of the Higher Education Authority. Member of the Pharmaceutical Society of Northern Ireland. Associate registrant of the Pharmaceutical Society of Great Britain. Aaron is directly involved in research activities as part of his role within Queen’s University Belfast. This involves research for funding bodies, industrial partners, and research councils. Aaron has reviewed publications for:•Expert Opinion on Drug Delivery• Journal of Visualised Experiments (JoVE) •Pharmaceutics• Education Sciences

08/03/2019

Mr Martin John Fisher Martin's wife previously worked for Celerion as a Research Nurse circa 2011-2012.Wife is currently a nurse with Orthoderm Health Clinic Hillsborough. See Documents tab for signed, scanned form.

05/03/2019

Miss Natalie Hayes None. See Documents tab for signed, scanned form

05/03/2019

Dr Anne Moorhead Chair of the School of Communication & Media Filter Committee at Ulster University (Risk and Ethics) Committee member on the research committee for the International Association for Communication in Healthcare. Regular member on Horizon2020 funding panels Section Editor for the Journal of Medical Internet Research (JMIR) Regular invited reviewer on numerous health journals and funding panels including BMJ, ESRC, NIHR Please see form in uploaded documents, signed 29.03.19

05/03/2019

Dr Elinor Johnston Present Post: Clinical Study Co-ordinator - Centre for experimental Medicine, QUB. See Documents tab for signed, scanned form.

05/03/2019

Mrs Cliona McDowell DoI from 03/02/14 As a Biostatistician for the NICTU, Cliona is involved as co-applicant on grant applications. She will therefore have to abstain from any reviews of applications where the NICTU is involved.

11/03/2019

Ms Mary McMahon None. See uploaded documents. 06/03/2019 Dr Kristel Miller Kristel works in Ulster University and is an active

researcher. Kristel also chairs the filter ethics committee for the Ulster Business School and sits on the University of Ulster's central research ethics committee. See Documents tab for signed, scanned form.

05/03/2019

Mr John Edward Mone Non-Executive Directory on Health and Social Care Board. See Documents tab for signed, scanned form.

05/03/2019

Professor Patrick Murphy None. See Documents tab for signed, scanned 05/03/2019


form. Dr Seamus O'Brien None. See Documents tab for signed, scanned

form. 05/03/2019

Dr Mark Reid Member of Helping Hand - Charity to Children's Hospital Belfast (RBHSC) See attached document in documents tab.

15/03/2019

Ms Marilyn Trimble None. See Documents tab for signed, scanned form.

05/03/2019

Ms Sue Trouton None 19/04/2018 Dr Ronald Atkinson None 12/04/2019


Meetings for Full Ethical Review 01 April 2018 - 31 March 2019:

Proportionate Review Sub-Committee Meetings held during 01 April 2018 - 31 March 2019:

Sub-Committee Meetings held during 01 April 2018 - 31 March 2019:


May 10/05/2018 10 June 14/06/2018 12 July 19/07/2018 11 August 09/08/2018 12 September 06/09/2018 11 October 11/10/2018 11 November 08/11/2018 9 December 06/12/2018 11 January 17/01/2019 11 February 14/02/2019 10 March 14/03/2019 11 11 full committee meetings were held during the reporting period.


April 23/04/2018 3 May 21/05/2018 3 June 18/06/2018 3 July 16/07/2018 3 August 28/08/2018 3 November 19/11/2018 3 December 17/12/2018 3 January 28/01/2019 3 February 25/02/2019 3 March 25/03/2019 3 10 proportionate review sub-committee meetings were held during the reporting period.


April 19/04/2018 2 May 01/05/2018 2 May 07/05/2018 2 June 05/06/2018 2 June 27/06/2018 2 July 16/07/2018 2 August 06/08/2018 2 August 24/08/2018 2 September 20/09/2018 2 September 20/09/2018 2


Details of inquorate meeting held: 01 April 2018 - 31 March 2019

October 18/10/2018 2 November 05/11/2018 2 November 16/11/2018 2 November 20/11/2018 2 November 30/11/2018 2 December 18/12/2018 2 January 10/01/2019 2 February 04/02/2019 2 March 01/03/2019 2 March 25/03/2019 2 20 sub-committee meetings were held during the reporting period. Date Reason Action taken


Attendance of Members at full committee meetings: 01 April 2018 - 31 March 2019

Attendance of Members at proportionate review sub-committee meetings: 01 April 2018 - 31 March 2019

Attendance of Members at sub-committee meetings: 01 April 2018 - 31 March 2019

Name Number of

Meetings Attended

Dr Ronald Atkinson 9 Dr Aaron Courtenay 1 Mr Martin John Fisher 6 Miss Natalie Hayes 6 Dr Elinor Johnston 7 Dr Justin Magee 3 Mrs Cliona McDowell 3 Ms Mary McMahon 10 Dr Kristel Miller 7 Mr John Edward Mone 5 Dr Anne Moorhead 8 Ms Aine Morrison 6 Professor Patrick Murphy 7 Dr Seamus O'Brien 9 Mr Leon O'Hagan 4 Dr Mark Reid 9 Ms Marilyn Trimble 7 Ms Sue Trouton 8 Dr Lisa Watt 4 Name Number of

Meetings Attended

Dr Elinor Johnston 8 Ms Mary McMahon 5 Dr Kristel Miller 1 Mr Barry Mimnagh 1 Mr John Edward Mone 1 Dr Anne Moorhead 4 Professor Patrick Murphy 3 Dr Seamus O'Brien 3 Mr Leon O'Hagan 2 Ms Sue Trouton 2 Name Number of

Meetings Attended

Mr John Edward Mone 7 Dr Anne Moorhead 10 Professor Patrick Murphy 3


Dr Seamus O'Brien 7 Mr Leon O'Hagan 5 Ms Sue Trouton 6


Training 01 April 2018 - 31 March 2019 Name of Member Date Event(s) attended Professor Patrick Murphy 05/12/2018 National Chairs Training Day Dr Mark Reid 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Ronald Atkinson 05/03/2019 HSC REC Training Day 5th

March 2019 Mr Martin John Fisher 05/03/2019 HSC REC Training Day 5th

March 2019 Miss Natalie Hayes 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Elinor Johnston 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Justin Magee 11/09/2018 Medical Device Training Ms Mary McMahon 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Kristel Miller 05/03/2019 HSC REC Training Day 5th

March 2019 Mr John Edward Mone 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Anne Moorhead 05/03/2019 HSC REC Training Day 5th

March 2019 Ms Aine Morrison 05/03/2019 HSC REC Training Day 5th

March 2019 Professor Patrick Murphy 05/03/2019 HSC REC Training Day 5th

March 2019 Dr Seamus O'Brien 26/06/2018 Good Clinical Practice

Refresher Dr Seamus O'Brien 05/03/2019 HSC REC Training Day 5th

March 2019 Ms Marilyn Trimble 05/03/2019 HSC REC Training Day 5th

March 2019 Ms Sue Trouton 05/03/2019 HSC REC Training Day 5th

March 2019 Mrs Cliona McDowell 05/03/2019 HSC REC Training Day 5th

March 2019


PART 2: REC WORKLOAD AND ACTIVITY DURING THE REPORTING PERIOD

Table 1: Applications assigned to a full committee meeting held within the reporting period:

Table 2: Breakdown of full applications and other activity during reporting period

Table 3: Decisions given at meetings held within the reporting period

Applications for full ethical review – Study Type Number % Clinical Trial of Investigational Medicinal Product 15 25.86 Phase 1 11 18.97 Gene Therapy 0 0.00 Research Tissue Bank (including renewals) 0 0.00 Research Database (including renewals) 4 6.90 Others 28 48.28 Total Applications Reviewed 58 100 Number of applications made invalid by the REC Manager 1 Number of applications withdrawn prior to the meeting 8 Number of student applications reviewed 12 Number of paediatric applications reviewed 5 Number of device applications reviewed 4 Number of prisoner applications reviewed 1 Number of applications involving adults unable consent reviewed 3 Number of applications reviewed that are funded by the US DHHS 0 Number of qualitative applications reviewed 5 Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 3 5.17 Favourable Opinion with Additional Conditions 9 15.52 Unfavourable Opinion 2 3.45 Provisional Opinion 44 75.86 Provisional Opinion Pending Consultation with Referee 0 0.00 Total 58 100 Number of studies sent back to full committee meeting for final opinion

0


Table 4: Summary of current status of applications reviewed during the reporting period

Status of applications at date of generation of report Number % Further Information Favourable Opinion with Standard Conditions

43 74.14

Further Information Favourable Opinion with Additional Conditions

1 1.72

Further Information Unfavourable Opinion 0 0.00 Favourable Opinion with Standard Conditions 3 5.17 Favourable Opinion with Additional Conditions 9 15.52 Unfavourable Opinion 2 3.45 Provisional Opinion 0 0.00 Provisional Opinion Pending Consultation with Referee 0 0.00 Further Information response not complete 0 0.00 No decision entered on system 0 0.00 Number of studies withdrawn after the meeting 0 0.00 Total 58 100


Table 5: Applications assigned to a proportionate review sub-committee within the reporting period

Table 7: Decisions given at proportionate review sub-committee meetings held within the reporting period

Table 6: Breakdown of PRS applications and other activity during reporting period:

Number of applications made invalid by the REC Manager 0 Number of studies withdrawn prior to the meeting 1 Number of student applications reviewed 15 Number of paediatric applications reviewed 4 Number of device applications reviewed 2 Number of qualitative applications reviewed 6

Total Applications Reviewed 30

Decisions taken at proportionate review sub-committee meetings

Number %

Favourable Opinion with Standard Conditions 7 23.33 Favourable Opinion with Additional Conditions 7 23.33 No Opinion transfer to full committee for review 2 6.67 Provisional Opinion 14 46.67 Unfavourable Opinion 0 0.00 Total 30 100


Table 8: Other Management Information based on the number of completed applications for th ti i d Average number of applications reviewed per full meeting 5.27 Number of completed applications for full ethical review 58 Number of completed applications for full ethical review over 60 days

0


0.00%

Number of completed applications for full ethical review over 40 days

0


0.00%

Number of days taken to final decision – average (mean) 28 Number of completed proportionate review applications for ethical review

28

Number of completed proportionate review applications for ethical review over 21 days

0

Number of completed proportionate review applications over 21 days as a % of total

0.00%

Number of SSAs (non-Phase 1) reviewed 14 Number of completed applications for SSA review over 25 days

1

Number of completed applications for SSA review over 25 days as % of all non- Phase 1 SSAs

7.14%

Number of SSAs (Phase 1) reviewed 12 Number of completed applications for SSA review over 14 days

0

Number of completed applications for SSA review over 14 days as % of all Phase 1 SSAs

0.00%

Number of substantial amendments reviewed 81 Number of completed substantial amendments over 35 days 0 Number of completed substantial amendments over 35 days as a % of total substantial amendments

0.00%

Number of completed substantial amendments over 28 days 2 Number of completed substantial amendments over 28 days as a % of total substantial amendments

2.47%

Number of modified amendments reviewed 1 Number of completed modified amendments over 14 days 0 Number of completed modified amendments over 14 days as a % of total modified amendments

0.00%

Number of non substantial amendments received 64 Number of substantial amendments received for information 0 Number of substantial amendments received for new sites/PIs

11

Number of annual progress reports received 126


Number of safety reports received 42 Number of Serious Adverse Events received 1 Number of final reports received 77

HSC REC B Research Ethics Committee Annual Report

Table 9.1: Breakdown of current status of all full applications reviewed within the reporting period Further Information Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0080 Magic glass evaluation in people with stroke 33 18/NI/0084 Phase 3 trial to evaluate subcutaneous elamipretide injections for PMM 33 18/NI/0091 Developing an arts intervention for patients receiving haemodialysis 30 18/NI/0101 Post-radiation dental disease 31 18/NI/0106 Epstein-Barr virus suppression in COPD (EViSCO) 25 18/NI/0108 EXACT-MCRPC Version 1.0 37 18/NI/0122 A Different Kind of Leaving - disabled young people leaving care. 28 18/NI/0127 Spotlight 34 18/NI/0128 EDP-305 in Subjects with Non-Alcoholic Steatohepatitis (NASH) 29 18/NI/0129 In-SIGHT study v2 24 May 2018 29 18/NI/0131 Glucagon-like peptide-1 and cardiac inflammation in diabetes 26 18/NI/0136 Healthcare, Through The Eyes Of Our Children 34 18/NI/0138 Impact of ileostomy on outcomes after rectal resection 32 18/NI/0154 Antimicrobial prescribing in care homes: a qualitative study 31 18/NI/0155 Relative Bioavailability of Ponatinib 5mg Capsules 33 18/NI/0164 Low-dose atropine eye drops for children with myopia in the UK 26 18/NI/0176 Vestibular Stimulation to Trigger Apidose Loss (VeSTAL) Clinical Trial 23 18/NI/0180 The Northern Ireland Cerebral Palsy Register (NICPR) 2018 33 18/NI/0183 UX Sensor Ileostomate Study 26 18/NI/0192 Comparing blood levels after different dosing schedules of aramchol 31 18/NI/0199 AIMM: Acipimox in Mitochondrial Myopathy 23 18/NI/0202 The impact of a health & wellbeing clinic following head & neck cancer 21 18/NI/0203 KX-ORAX-012 Oraxol food effect study 26 18/NI/0204 B9991030 - JAVELIN OVARIAN PARP 100 24 18/NI/0210 LAL Deficiency Registry 36 18/NI/0212 Walking fOR Health: The WORtH trial 31 18/NI/0219 BrainWaveBank usability for young adult patients [UHR/ARMS] 34 18/NI/0224 Double-Blind, Efficacy and Safety of Durvalumab plus Olaparib 27 19/NI/0001 Anticipatory Care Planning for older adults at risk of decline (v2) 23 19/NI/0002 Attention Autism for Primary School Children with Autism 24 19/NI/0003 Middle Eastern immigrant parents' experiences of child healthcare 22 19/NI/0005 MOSAIC PSA014 29


19/NI/0016 DECADE 29 19/NI/0018 Birth parents' experiences of post-adoption contact 28 19/NI/0024 Efficacy and Safety Study of PRN1008 in Patients with Pemphigus 31 19/NI/0027 An Evaluation of the Family Drug and Alcohol Court in NI 30 19/NI/0028 Study of MGD013 in Patients with Unresectable or Metastatic Neoplasms 28 19/NI/0039 GSK3186899 First Time in Human Study 36 19/NI/0045 Strenghtening Leadership In Community Contexts (SLICC) 33 19/NI/0046 ADME study of [14C]AZD5718 in healthy male subjects (QSC200694) 29 19/NI/0052 Survey on medication adherence and attitudes towards medication 30 19/NI/0053 Oral Health Video Study 37 19/NI/0055 HOYA 3601; Version 1 32

Further Information Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0109 Primary Joint Service Outcomes Database 28


Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0078 Safety, blood levels and effects of UCB0107 in Japanese volunteers 21 18/NI/0107 Effects of GSK3039294 on heart rhythm in healthy participants v1 22 18/NI/0137 Phase 1 PK study in healthy subjects (QSC118240) 20

Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0075 SJX-653 – first doses in men; ver 1 20 18/NI/0077 Mediterranean diet in people with subjective cognitive impairment 20 18/NI/0142 Reliability of a Goniometer Watch to Measure Forearm Rotation 21 18/NI/0144 Single and repeated doses of SJX-653 in postmenopausal women 22 18/NI/0145 Safety, Tolerability, PK and PD Study of Inhaled ION-827359 22


Table 9.2: Breakdown of current status of all PRS applications reviewed within the reporting period

18/NI/0177 Effect of aramchol on blood levels of midazolam and atorvastatin, v1 21 18/NI/0178 Phase 1/2, Drug-Drug Interaction Study of FDL169&FDL176 in HV&CF subs 21 18/NI/0179 Phase 1 ADME and IV microtracer study in healthy females (QSC118021) 19 18/NI/0205 Mobile-EEG based profiling of cognitive impairment in PD and dementia 21

Unfavourable Opinion REC Reference Title Number of Days on Clock 18/NI/0132 The Genomic Basis of Alzheimer's Disease in Ireland 30 19/NI/0026 The Heart Hive 29


Provisional Opinion Pending Consultation with Referee REC Reference Title Number of Days on Clock


Withdrawn after the meeting REC Reference Title Number of Days on Clock Further Information Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0081 Virtual reality headsets for patients undergoing regional anaesthesia 7 18/NI/0082 Blood flow dynamics in the surviving adult congenital heart patient 8 18/NI/0086 Alkaptonuria Questionnaire Study 10 18/NI/0102 Treatment understanding and certainty in MS patients. 14


18/NI/0162 SNIFS - Optimising Materials for SNIFS Saline Irrigation 13 18/NI/0243 Experience of transitional dental care for young people with trauma 11 19/NI/0019 Oral biofilms and dementia version 1 8 19/NI/0043 Empower project 7 19/NI/0073 Activity, Balance and COPD (ABCOPD) 12 19/NI/0074 'Asian Indian' caregivers' experience of dementia services. 16 19/NI/0075 Arm cycling improves trunk function 15

Further Information Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0215 Analysis of remote monitoring / virtual clinic data in Cystic Fibrosis 12 18/NI/0241 ‘The Crohn’s Stricture CS3M Study’ (CS3M) 11 19/NI/0025 CAMHS - AMHS transition for those with ASD: Multiple perspectives 12


Favourable Opinion with Standard Conditions REC Reference Title Number of Days on Clock 18/NI/0119 SUMMIT UK - Small Cell Lung Cancer Outcomes Among Patients in the UK 8 18/NI/0134 Intervention development of a new programme for managing high BP 8 18/NI/0161 Immunotherapy for HCHWA-D 8 18/NI/0214 Outcomes following early parenteral nutrition use in preterm neonates 8 18/NI/0242 PROMOTE-BIO study 7 19/NI/0020 Improving early detection of colorectal cancer through simulation 6 19/NI/0048 FSL Impact Study - version no 1 7

Favourable Opinion with Additional Conditions REC Reference Title Number of Days on Clock 18/NI/0103 Serpins DMD 2 8 18/NI/0120 Pre-hospital pain management in children 8 18/NI/0121 PRINT 8


18/NI/0133 SS-INQ Information Needs Questionnaire in Sjögren’s Syndrome 8 18/NI/0135 I6Q-MC-BIFD SC Injections of Buffer Matrices in Healthy Subjects 7 18/NI/0160 CAPTION: CompArison of Pressure catheTers durIng urOdyNamics (v1.0) 10 19/NI/0044 Participants involvement in decision making for aortic stenosis 7

Unfavourable Opinion REC Reference Title Number of Days on Clock



Withdrawn after the meeting REC Reference Title Number of Days on Clock


Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting period Favourable opinion Amendment REC Reference


06/NIR02/107/AM06 Periodontal disease and cardiovascular disease 06/06/2018 17 08/NIR03/113/AM21 The TUDA Study 13/04/2018 11 09/NIR02/66/AM08 Physical Activity and the Regeneration of Connswater (the

PARC Study) 08/06/2018 17

12/NI/0154/AM14 Pomalidomide in Relapsed and/or Refractory Multiple Myeloma Patients

IB and ICF Amendment

23/11/2018 22

12/NI/0154/AM15 Pomalidomide in Relapsed and/or Refractory Multiple Myeloma Patients

Change of EU Legal Representat

19/02/2019 13

13/NI/0129/AM08 LAL Deficiency Registry 09/04/2018 9 13/NI/0159/AM03 The Northern Ireland Cerebral Palsy Register (NICPR) 15/01/2018 9 14/NI/1037/AM16 Treatment of lymphoma by Betalutin targeted internal radiation

therapy 03/04/2018 15

14/NI/1037/AM17 Treatment of lymphoma by Betalutin targeted internal radiation therapy

Correction to site name and ad

27/04/2018 4

14/NI/1037/AM20 Treatment of lymphoma by Betalutin targeted internal radiation therapy

Changes to Protocol (LYMRIT-

37

27/11/2018 19

14/NI/1038/AM10 The Paediatric EVICELÂ® Neuro Study Substantial Amendment #5 –

Cha

18/05/2018 17

14/NI/1038/AM12 The Paediatric EVICELÂ® Neuro Study 02/08/2018 26 14/NI/1038/AM13 The Paediatric EVICELÂ® Neuro Study SA07 10/12/2018 8 14/NI/1120/AM09 EDNA 31/05/2018 24 15/NI/0137/AM15 Phase 1 Study of BLU-554 in Patients with Hepatocellular

Carcinoma 13/02/2019 19

15/NI/0188/AM07 Long-term Study of FerriproxÂ® in Patients with Sickle Cell Disease

LA38-EXT 3.1 14/02/2019 28

15/NI/0234/AM03 Mobile-EEG based identification and tracking of Multiple Sclerosis

26/09/2018 18

15/NI/0270/AM03 The use of social media for healthcare advice: A focus group study

27/07/2018 24


16/NI/0038/AM01 INCA SUN 06/07/2018 9 16/NI/0055/AM06 CIBRAC 13/02/2019 13 16/NI/0185/AM05 SITless RCT 25/10/2018 7 16/NI/0186/AM02 CBC project 29/08/2018 26 16/NI/0214/AM05 Inhaled Oxytocin in women after birth and in nonpregnant

women Substantial

Amendment 3 22/06/2018 23

16/NI/0214/AM06 Inhaled Oxytocin in women after birth and in nonpregnant women

29/08/2018 24

16/NI/0214/AM07 Inhaled Oxytocin in women after birth and in nonpregnant women


05/11/2018 24

16/NI/0239/AM02 MARI 16/04/2018 18 17/NI/0007/AM02 Evaluation of the Early Intervention Support Service in NI 05/07/2018 9 17/NI/0026/AM02 Quality Care For Children- Evidence Informed Inspection

Practice 21/05/2018 16

17/NI/0086/AM14 A study to assess the safety, tolerability and PK of PTI-428 in CF.

25/05/2018 9

17/NI/0086/AM15 A study to assess the safety, tolerability and PK of PTI-428 in CF.

02/07/2018 16

17/NI/0103/AM04 Safety & Efficacy Study of Orally Administered DS102 in COPD Patients

2 10/04/2018 8


27/04/2018 4


19/02/2019 14

17/NI/0107/AM03 The Healthcare Passport Study 09/05/2018 22 17/NI/0108/AM04 Efficacy and Safety of NA-1 in subjects with Acute Ischemic

Stroke 01/06/2018 25

17/NI/0108/AM05 Efficacy and Safety of NA-1 in subjects with Acute Ischemic Stroke

05/03/2019 22

17/NI/0113/AM06 GS-US-419-4016 Filgotinib in treatment of Perianal Fistulizing Crohns

SA#2 ICF 12/04/2018 7

17/NI/0113/AM07 GS-US-419-4016 Filgotinib in treatment of Perianal Fistulizing Crohns

Substantial Amendment 03 -

Upd

17/12/2018 24

17/NI/0119/AM02 High-Resolution Magnetic Resonance Imaging of Carotid Artery Plaque

2 10/12/2018 21


17/NI/0132/AM01 Stratification in Alzheimer's disease 13/11/2018 14 17/NI/0141/AM03 SPECTA: Screening Cancer Patients for Efficient Clinical Trial

Access 22/05/2018 9

17/NI/0141/AM06 SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

UK03 12/02/2019 18

17/NI/0142/AM01 Clinical decision support app for dementia 18/06/2018 17 17/NI/0169/AM03 Petechiae In Children (PIC) Study 12/06/2018 17 17/NI/0172/AM02 Trauma, Cognition, Transition and Outcome in UHR Psychosis 22/10/2018 6 17/NI/0192/AM02 RADAR-2 18/07/2018 18 17/NI/0193/AM03 Pilot testing of the S-MAP intervention in community

pharmacies 3.0 02/10/2018 20

17/NI/0193/AM04 Pilot testing of the S-MAP intervention in community pharmacies

Amendment 4 (Substantial) 7.12

07/12/2018 11

17/NI/0193/AM05 Pilot testing of the S-MAP intervention in community pharmacies

Amendment 05 (Substantial)

11/02/2019 21

17/NI/0215/AM01 HV Study to Evaluate the PK, Safety & Tolerability of MEDI7219 117903

18/03/2019 8

17/NI/0227/AM03 Infant feeding, non-nutritive sucking and speech development 10/10/2018 25 17/NI/0229/AM02 Feasibility study of the use of point-of-care NP measurement 2, 15 November

2018 04/12/2018 14

18/NI/0002/AM01 Trauma, pro-inflammatory cytokines, and cognitive architecture (ver1)

25/06/2018 21

18/NI/0008/AM02 Safety, Tolerability and PK of XEN901 in Healthy Subjects (QCL118145)

15/06/2018 9

18/NI/0008/AM03 Safety, Tolerability and PK of XEN901 in Healthy Subjects (QCL118145)

08/08/2018 13

18/NI/0046/AM01 Older Adults' Perspective on the Therapeutic Alliance 25/09/2018 21 18/NI/0051/AM01 Experiences of ABI patients and family carers of rehabilitation 11/09/2018 12 18/NI/0064/AM01 Genetic control of HLA expression Substantial

amendment #1 04/06/2018 24

18/NI/0075/AM01 SJX-653 – first doses in men; ver 1 31/05/2018 7 18/NI/0075/AM02 SJX-653 – first doses in men; ver 1 24/08/2018 24 18/NI/0080/AM01 Magic glass evaluation in people with stroke 11/12/2018 20 18/NI/0084/AM01 Phase 3 trial to evaluate subcutaneous elamipretide injections

for PMM 06/11/2018 15

18/NI/0091/AM01 Developing an arts intervention for patients receiving 05/11/2018 15


haemodialysis 18/NI/0091/AM02 Developing an arts intervention for patients receiving

haemodialysis 26/02/2019 28

18/NI/0101/AM01 Post-radiation dental disease 18/10/2018 19 18/NI/0109/AM01 Primary Joint Service Outcomes Database 08/02/2019 24 18/NI/0121/AM01 PRINT 25/10/2018 15 18/NI/0127/AM01 Spotlight Substantial

Amendment #1 26/08/2018 19

18/NI/0131/AM01 Glucagon-like peptide-1 and cardiac inflammation in diabetes 19/03/2019 8 18/NI/0137/AM01 Phase 1 PK study in healthy subjects (QSC118240) 10/10/2018 12 18/NI/0144/AM01 Single and repeated doses of SJX-653 in postmenopausal

women 21/09/2018 29

18/NI/0144/AM02 Single and repeated doses of SJX-653 in postmenopausal women

22/02/2019 8

18/NI/0145/AM01 Safety, Tolerability, PK and PD Study of Inhaled ION-827359 07/12/2018 12 18/NI/0154/AM01 Antimicrobial prescribing in care homes: a qualitative study 16/11/2018 11 18/NI/0155/AM02 Relative Bioavailability of Ponatinib 5mg Capsules 17/10/2018 1 18/NI/0164/AM02 Low-dose atropine eye drops for children with myopia in the

UK 12/12/2018 6

18/NI/0177/AM01 Effect of aramchol on blood levels of midazolam and atorvastatin, v1

29/10/2018 7

18/NI/0183/AM01 UX Sensor Ileostomate Study 08/11/2018 7 18/NI/0215/AM01 Analysis of remote monitoring / virtual clinic data in Cystic

Fibrosis Number 1 (15 Feb

2019) 20/02/2019 26

19/NI/0001/AM01 Anticipatory Care Planning for older adults at risk of decline (v2)

20/03/2019 7

Unfavourable opinion Amendment REC Reference


17/NI/0136/AM02 Safety and blood levels after different forms of RhuDex; v2 05/10/2018 35


Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period

Favourable opinion timeline Amendment REC Reference


17/NI/0136/AM02/1 Safety and blood levels after different forms of RhuDex; v2 13/11/2018 3

Unfavourable opinion timeline Amendment REC Reference



Table 11: Items exceeding timelines

Full applications for ethical review over 60 day timeline REC Reference Title Number of Days on Clock

Proportionate review applications for ethical review over 21 day timeline REC Reference Title Number of Days on Clock

SSAs (non Phase 1) over 25 day timeline REC Reference Title Number of Days on Clock 18/NI/0175 Visual performance measures in 28

SSAs (Phase 1) over 14 day timeline REC Reference Title Number of Days on Clock

Substantial Amendments over 35 day timeline Amendment REC Reference


Modified Amendments over 14 day timeline Amendment REC Reference
