RES Committee North West - Liverpool East Annual Report 01 ... · Mr Alex Newgrosh None 16/01/2015 Professor Neil Pender None 16/10/2014 Miss Kimberley Saint I sit on the Trustees

Research Ethics Service

RES Committee North West - Liverpool East

Annual Report

01 April 2014 - 31 March 2015

RES Committee North West - Liverpool East Annual Report Page 2

Part 1 – Committee Membership and Training

Name of REC: RES Committee North West - Liverpool East Type of REC: REC recognised to review CTIMPS in patients - type iii

Type of Flag: Paediatrics, Research Tissue Banks Chair: Mrs Glenys J Hunt Vice-Chair: Professor Neil Pender Alternate Vice-Chair: Dr Peter Walton REC Manager: Miss Helen Penistone REC Assistant: Miss Ewa Grzegorska Committee Address: Barlow House

3rd Floor 4 Minshull Street Manchester M1 3DZ

Telephone: 0161 625 7832 Email: [email protected]


Chair’s overview of the past year:

Unfortunately two of our long-serving members left last year - Jean Pownceby and Richard Sarginson. Due to low numbers we have sometimes struggled to obtain a quorum on some occasions, and even had to cancel the February meeting, we also have had some difficulty finding members to do proportionate review sub-committee work. However at the end of the year we welcomed one new member, Sue Fitzpatrick, and hopefully we should soon have some more recruits. Exactly one-third of our applications last year were CTIMPS and I would especially like to thank Maureen Hendy for her hard work on these.

I notice that all current members did attend at least one training session in the last year, which is an improvement on previous year.

We were very kind to our applicants, only one of the full applications having an unfavourable decision, and two of the proportionate review applications. Some of the comments from the committee to the applicants were very supportive and helpful and a number of the applicants expressed their thanks for our input as they left which indicates we are fulfilling a useful function.

All of the committee members are committed, enthusiastic and hard-working and their efforts are much appreciated.


RES Committee North West - Liverpool East Membership

NRES Committee North West - Liverpool East: Co-opted Members

Name Profession Expert or Lay

Dates

Appointed Left

Mr John Bridson Clinical Ethicist Expert 21/06/2007

Dr Zoe Edwards Clinical Psychologist Expert 21/02/2011

Mrs Sue Fitzpatrick Director Lay 14/04/2015

Mrs Elizabeth Gordon Retired Magistrate Lay Plus 01/06/2013

Mrs Maureen Hendry Pharmacist Expert 12/07/2010

Mrs Glenys J Hunt Solicitor Lay Plus 22/08/2005

Professor Ebrahim Khalil Naderali

Professor of Human Physiology

Expert 21/02/2011

Mr Alex Newgrosh Quality Assurance Manager

Lay Plus 16/09/2010

Professor Neil Pender Professor of Orthodontics Expert 27/08/2005

Mrs Jean Pownceby Lay Member Lay Plus 11/01/2006 20/06/2014

Miss Kimberley Saint Clinical Scientist Expert 27/09/2012

Dr Richard Sarginson Consultant (Anaesthesia/PICU)

Expert 16/02/2005 05/04/2015

Dr Peter Walton Retired Clinical Scientist Lay 14/05/2008

Name Profession Status Meeting date attended

Chris Houston Retired Lay Member Lay 21 August 2014


RES Committee North West - Liverpool East: Members’ Declarations of Interest:

Name Declaration of Interest Date

Mr John Bridson Member of the Board of Trustees of the UK Clinical Ethics Network. I am employed as a Clinical Ethicist at the Royal Liverpool and Broadgreen University Hospitals NHS Trust (RLBUHT) and I am sometimes asked for advice about research applications and protocol development. I am a member of the RLBUHT Cardiology Research Committee. I hold an Honorary Lectureship in the Department of Health Services research, Institute of Psychology, Health and Society, University of Liverpool

11/12/2014

Dr Zoe Edwards None 11/12/2014

Mrs Elizabeth Gordon None 16/10/2014

Mrs Maureen Hendry Member of Medicines Optimisation Clinical Reference Group (CRG) NHS England

09/12/2014

Mrs Glenys J Hunt None 15/10/2014

Mr Alex Newgrosh None 16/01/2015

Professor Neil Pender None 16/10/2014

Miss Kimberley Saint I sit on the Trustees Board of the Institute of Physics and Engineering in Medicine. This is my professional body. It is run as a charity. My role includes me being listed as a Director and I am registered with the Charities Commission. It is unlikely that the Professional body will directly engage in research, but there is a possibility. I work within the NHS. My role involves research and development work. There is a chance that I may be involved with research that requires ethical review or otherwise brings me into contact with the HRA

31/10/2014

Dr Richard Sarginson None 09/12/2014

Dr Peter Walton None 11/12/2014


Meetings for Full Ethical Review 01 April 2014 - 31 March 2015:

Proportionate Review Sub-Committee Meetings held during 01 April 2014 - 31 March 2015:

Sub-Committee Meetings held during 01 April 2014 - 31 March 2015:

Month Date Number of Members Present at Meeting

April 17/04/2014 9

May 15/05/2014 9

June 19/06/2014 9

August 21/08/2014 7

September 18/09/2014 8

October 16/10/2014 8

November 20/11/2014 9

December 11/12/2014 8

January 15/01/2015 10

March 19/03/2015 10

10 full committee meetings were held during the reporting period.


April 08/04/2014 3

May 13/05/2014 3

July 01/07/2014 3

August 05/08/2014 5


November 18/11/2014 3

January 09/01/2015 3

7 proportionate review sub-committee meetings were held during the reporting period.


April 03/04/2014 2

April 17/04/2014 2

May 01/05/2014 2

May 15/05/2014 2

June 10/06/2014 2

June 19/06/2014 2

June 25/06/2014 2

June 30/06/2014 3

July 10/07/2014 3

July 11/07/2014 3

July 15/07/2014 3

July 17/07/2014 2

July 31/07/2014 2

August 21/08/2014 2



Details of inquorate meeting held:01 April 2014 - 31 March 2015


October 09/10/2014 2

October 23/10/2014 2

November 06/11/2014 2

November 20/11/2014 2

December 11/12/2014 2

January 05/01/2015 2

January 15/01/2015 2

February 03/02/2015 2

February 19/02/2015 2

March 05/03/2015 2

March 19/03/2015 2

27 sub-committee meetings were held during the reporting period. 0


Attendance of Members at full committee meetings:01 April 2014 - 31 March 2015

Attendance of Members at proportionate review sub-committee meetings: 01 April 2014 - 31 March 2015

Attendance of Members at sub-committee meetings: 01 April 2014 - 31 March 2015

Name Number of Meetings Attended

Mr John Bridson 8

Dr Zoe Edwards 8

Mrs Elizabeth Gordon 9

Mrs Maureen Hendry 9

Mrs Glenys J Hunt 8

Mr Alex Newgrosh 6

Professor Neil Pender 8

Mrs Jean Pownceby 3

Miss Kimberley Saint 7

Dr Richard Sarginson 10

Dr Peter Walton 10


Mr John Bridson 2

Dr Zoe Edwards 2


Mrs Maureen Hendry 1

Mrs Glenys J Hunt 3

Mr Alex Newgrosh 1


Mrs Jean Pownceby 1


Dr Richard Sarginson 1

Dr Peter Walton 4


Mr John Bridson 1


Mrs Glenys J Hunt 22

Mr Alex Newgrosh 1



Dr Peter Walton 15


Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Mr John Bridson 21/07/2014 The Ethical Issues of Research Involving Children

Dr Zoe Edwards 21/07/2014 The Ethical Issues of Research Involving Children

Mrs Elizabeth Gordon 21/07/2014 The Ethical Issues of Research Involving Children

Mrs Elizabeth Gordon 04/01/2015 Equality and Diversity Online

Mrs Maureen Hendry 27/11/2014 Statistical advice for RECs

Mrs Maureen Hendry 31/03/2015 Medical Devices

Mrs Glenys J Hunt 12/01/2015 CTIMP training day

Mr Alex Newgrosh 24/06/2014 HTA Advanced

Professor Neil Pender 22/09/2014 The practicalities of running a REC

Professor Neil Pender 12/01/2015 CTIMP training

Miss Kimberley Saint 24/06/2014 Human Tissue Act (Advanced Training in the use of Tissues in

Research)

Dr Peter Walton 11/02/2015 Equality and Diversity online


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 16 33.33

Phase 1 0 0.00

Gene Therapy 0 0.00

Research Tissue Bank (including renewals) 1 2.08

Research Database (including renewals) 0 0.00

Others 31 64.58

Total Applications Reviewed 48 100

Number of applications made invalid by the REC Manager 4

Number of applications withdrawn prior to the meeting 0

Number of student applications reviewed 8

Number of paediatric applications reviewed 13

Number of device applications reviewed 1

Number of prisoner applications reviewed 0

Number of applications involving adults unable consent reviewed 0

Number of applications reviewed that are funded by the US DHHS 0

Number of qualitative applications reviewed 1

Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 4 8.33

Favourable Opinion with Additional Conditions 14 29.17

Unfavourable Opinion 1 2.08

Provisional Opinion 29 60.42

Provisional Opinion Pending Consultation with Referee 0 0.00

Total 48 100

Number of studies sent back to full committee meeting for final opinion

2


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

28 58.33

Further Information Favourable Opinion with Additional Conditions

0 0.00

Further Information Unfavourable Opinion 1 2.08





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 48 100


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 22

Number of studies withdrawn prior to the meeting 1

Number of student applications reviewed 3

Number of paediatric applications reviewed 0

Number of device applications reviewed 0

Number of qualitative applications reviewed 0

Total Applications Reviewed 12

Decisions taken at proportionate review sub-committee meetings

Number %



No Opinion transfer to full committee for review 1 8.33



Total 12 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 4.80

Number of applications for full ethical review 48

Number of applications for full ethical review over 60 days 0

Number of applications over 60 days as a % of total 0.00%

Number of applications for full ethical review over 40 days 3

Number of applications over 40 days as a % of total 6.25%

Number of days taken to final decision – average (mean) 29

Number of proportionate review applications for ethical review

11

Number of proportionate review applications for ethical review over 14 days

2

Number of proportionate review applications over 14 days as a % of total

18.18%

Number of SSAs (non-Phase 1) reviewed 4

Number of applications for SSA review over 25 days 0

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

0.00%

Number of SSAs (Phase 1) reviewed 0

Number of applications for SSA review over 14 days 0

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

0.00%

Number of substantial amendments reviewed 84

Number of substantial amendments over 35 days 0

Number of substantial amendments over 35 days as a % of total substantial amendments

0.00%

Number of substantial amendments over 28 days 10

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

11.90%

Number of modified amendments reviewed 5

Number of modified amendments over 14 days 0

Number of modified amendments over 14 days as a % of total modified amendments

0.00%

Number of minor amendments received 55

Number of substantial amendments received for information 1

Number of substantial amendments received for new sites/PIs

29

Number of annual progress reports received 53

Number of safety reports received 25

Number of Serious Adverse Events received 0

Number of final reports received 26

RES Committee North West - Liverpool East Research Ethics Committee Annual Report Page 14

Table 9.1: Breakdown of current status of all full applications reviewed within the reporting period


REC Reference Title Number of Days on Clock

09/H1002/67+5 Collection and storage of tissue for research 31

14/NW/0158 Personalisation of Voriconazole therapy in Children(PVC) 44

14/NW/0203 Development of outcome measures in juvenile localised scleroderma 37

14/NW/0209 Botox under local anaesthetic for OAB 26

14/NW/0211 XENIC: The effects of XEN-D0501 on cough frequency in chronic cough 36

14/NW/0232 Neurotransmitters and visual cortex plasticity 40

14/NW/0257 Contrasting bipolar disorder and borderline personality disorder -1 33

14/NW/0302 BOTOXÂ® for Treatment of Urinary Incontinence in patients 12-17 yrs old 31

14/NW/0355 Safety, Tolerability and Efficacy Study of Pneumococcal Vaccine 38

14/NW/1016 The value and cost of different forms of oral health information 43

14/NW/1038 PHASE 0 STUDY TO VALIDATE PD ENDPOINTS IN HEALTHY SUBJECTS 24

14/NW/1191 The use of contextualised body data in cardiac rehabilitation 36

14/NW/1227 A Phase III study of BAY 81-8973 in children with severe haemophilia A 34

14/NW/1239 Guselkumab in Psoriasis following inadequate Ustekinumab response 25

14/NW/1292 CA209-214 Nivolumab combined with Ipilimumab versus Sunitinib in RCC 27

14/NW/1293 Visual function in children with CVI. Version 1.0 26

14/NW/1334 Biomarkers of the progression of Barrett's oesophagus. Version 1 28

14/NW/1402 T-cell regulation in HPV+ve OPSCC and normal tonsil 17

14/NW/1437 The Pharmacoeconomics of Age-inappropriate Formulations (AiFs) 25

14/NW/1445 Breast Cancer Risk Communication version 1.0 22

15/NW/0021 BBC 30

15/NW/0023 Social identity and pulmonary rehabilitation 27

15/NW/0045 Systems Medicine Analysis of Inflammatory Bowel Disease 20

15/NW/0055 ReFLeCT 23

15/NW/0093 Dose of remifentanil for cardiac scans under anaesthesia in children. 26

15/NW/0146 Pilot Study of Repeated Mucosal Sampling on EHPC model 34

15/NW/0225 SAFE: intervention development and pilot RCT. 31

15/NW/0226 Home administration of benralizumab in patients with severe asthma 29




Further Information Unfavourable Opinion


14/NW/1312 WHEAT: WithHolding Enteral feeds Around packed red cell Transfusion 34

Favourable Opinion with Standard Conditions


14/NW/0280 EHOD and Cystadane Surveillance protocol 21

14/NW/0350 Nivolumab or Nivolumab + Ipilimumab vs Bevacizumab in Recurrent GBM 22

14/NW/1015 Copper (II) Chelation therapy in the treatment of HCM 22

14/NW/1189 ACTION:Cancer patient involvement in medical decision making V 1.0 37

Favourable Opinion with Additional Conditions


14/NW/0287 An exploration of clients’ experiences of ending DBT 21

14/NW/0300 SAPROF 4 21

14/NW/1071 Endotracheal suctioning in post-operative cardiac infants 22

14/NW/1097 PIANO Study - PLX3397 c-KIT in advanced acral and mucosal melanoma 22

14/NW/1357 Psychological therapy in early intervention services 27

14/NW/1358 SELINEXOR COMPARED TO PHYSICIANS CHOICE IN RELAPSED OR REFRACTORY AML

27

14/NW/1427 Effects of inhaled CVT-301 in Subjects with Parkinson’s disease 22

14/NW/1455 Non-specific Effects of Typhoid Vaccination 21

14/NW/1460 LAIV and EHPC 21

14/NW/1474 Antimicrobial Hernia Repair Device Clinical Study 13-10 21

14/NW/1497 GARMIN-II: double-blind randomised controlled trial of lesogaberan in cough 21

15/NW/0035 BehÃ§et’s syndrome in children and young people in the United Kingdom 20

15/NW/0052 BeaCh: interactions between bronchoconstriction and cough in asthma 30

15/NW/0209 An evaluation of six asbestos related lung cancer cases 21

Unfavourable Opinion



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

14/NW/1166 An investigation into a Trauma Focused Psychotherapy process 44

Provisional Opinion


Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting




14/NW/1188 The validity of informed consent for inguinal hernia surgery 16

14/NW/1289 Menstrual disturbance associated with HIV/AIDS 12

14/NW/1461 A discrete choice experiment for management of diverticulitis. 13



14/NW/1181 Is Skype an acceptable tool to follow-up liver cancer patients? 18

Further Information Unfavourable Opinion



Favourable Opinion with Standard Conditions


14/NW/0224 Perceptions of care during antenatal perinatal and postnatal period 12

15/NW/0057 PBAF and genome stability in renal cell carcinoma 9

Favourable Opinion with Additional Conditions


14/NW/0324 Illness Perception in Glaucoma 14

14/NW/1206 EAGLE 9

15/NW/0053 Ghrelin, IBD and the Relationship with Adiposity 9

Unfavourable Opinion


14/NW/0329 Nursing hourly rounding (version 1) 13

15/NW/0056 Psychological Outcomes Following Mastectomy & Immediate Reconstruction 7

Provisional Opinion


Further information response not complete


Withdrawn after the meeting



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

08/H1002/71/AM12 Combination antibiotic therapy in treatment of active Crohn's disease

Amendment 8 27/02/2014 12

10/H1002/29/AM08 Extension study for S1P1 agonist in Multiple Sclerosis PI & CI change 10/03/2014 28

10/H1002/29/AM10 Extension study for S1P1 agonist in Multiple Sclerosis 1 21/08/2014 20

10/H1002/29/AM12 Extension study for S1P1 agonist in Multiple Sclerosis Global Amendment 5 dated 6 Nov

11/12/2014 29

10/H1002/48/AM13 Safety and Efficacy of Paricalcitol in Paediatric Stage 3/4 CKD 13 22/05/2014 14

10/H1002/49/AM03 Investigation of myometrial contractility 3 17/06/2014 13

10/H1002/80/AM18 Subcutaneous Insulin: Pumps or Injections (SCIPI) Version Number 1.0

27/02/2015 19

11/NW/0533/AM03 Hypogonadism and Endothelial Dysfunction in Type 2 Diabetes.

08/08/2014 31

12/NW/0021/AM13 Ketamine-ECT Study 7.0 22/05/2014 18

12/NW/0021/AM15 Ketamine-ECT Study 04/07/2014 9

12/NW/0021/AM16 Ketamine-ECT Study 14/10/2014 7

12/NW/0021/AM17 Ketamine-ECT Study Amendment 12 23/01/2015 15

12/NW/0137/AM03 Everolimus in patients with non functioning NETs (RADIANT-4) 09/06/2014 15

12/NW/0361/AM08 A study of Standard and New Antiepileptic Drugs – SANAD-II SA5 13/06/2014 34

12/NW/0361/AM10 A study of Standard and New Antiepileptic Drugs – SANAD-II 29/09/2014 15

12/NW/0367/AM11 Belimumab vs placebo, plus standard therapy in paediatric SLE Substantial Amendment 8

18/02/2014 17

12/NW/0367/AM12 Belimumab vs placebo, plus standard therapy in paediatric SLE Substantial Amendment 9

03/11/2014 26

12/NW/0500/AM02 Health & Employment After Fifty (the HEAF Study) Substantial Amendment 1

15/04/2014 21

12/NW/0500/AM03 Health & Employment After Fifty (the HEAF Study) Substantial Amendment 2

04/12/2014 7

12/NW/0585/AM08 Trastuzumab Emtansine (T-DM1) 2nd line Metastatic Gastric Study

SA#6 09/04/2014 22

12/NW/0585/AM09 Trastuzumab Emtansine (T-DM1) 2nd line Metastatic Gastric Study

Substantial Amendment #7

09/09/2014 15


dated

12/NW/0717/AM05 Fosaprepitant PK/PD CINV in Pediatric Cancer Patients Substantial Amendment #5

16/04/2014 22

12/NW/0717/AM06 Fosaprepitant PK/PD CINV in Pediatric Cancer Patients 11/06/2014 13

12/NW/0717/AM08 Fosaprepitant PK/PD CINV in Pediatric Cancer Patients Substantial Amendment #7

10/02/2015 14

12/NW/0739/AM04 A Ph.I/II Dose Escalation Study and Expansion safety/efficacy study.

1 29/08/2014 7

12/NW/0739/AM05 A Ph.I/II Dose Escalation Study and Expansion safety/efficacy study.

PCI 202/12-UK004 23/12/2014 20

12/NW/0802/AM07 Study of Oral Laquinimod in Subjects with Multiple Sclerosis Global Amendment 2

07/07/2014 10

12/NW/0802/AM09 Study of Oral Laquinimod in Subjects with Multiple Sclerosis 09/10/2014 12

12/NW/0814/AM07 Efficacy & Safety/Tolerability of Subcutaneous SCH900222/MK-3222

Updated Investigator Brochure

18/12/2014 20

12/NW/0815/AM02 Circadian control of human immunity Amendment 2 28/04/2014 19

13/NW/0084/AM04 Aprepitant for the treatment of cough in lung cancer 4.0 15/05/2014 21

13/NW/0084/AM05 Aprepitant for the treatment of cough in lung cancer 6.0 04/07/2014 6

13/NW/0162/AM05 EXPERT: EXPerience of a health website Evaluated in a Research Study

Amendment 4 28/03/2014 34

13/NW/0193/AM03 intraprostatic injection of NX-1207 in patients with LUT Protocol Amendment 2

25/07/2014 8

13/NW/0193/AM05 intraprostatic injection of NX-1207 in patients with LUT 04/11/2014 22

13/NW/0259/AM03 Physical fitness and quality of life in rectal cancer patients 01/07/2014 21

13/NW/0265/AM04 DESTINY Amendment 3 07/01/2015 13

13/NW/0269/AM01 Reading difficulties in children with rolandic epilepsy (version1) Amendment 1 16/02/2014 9

13/NW/0552/AM02 Packing of perianal abscess cavities study. Substantial Amendment 2

24/02/2014 31

13/NW/0552/AM03 Packing of perianal abscess cavities study. 1 15/07/2014 6

13/NW/0583/AM02 Evaluation of metformin XR vs metformin IR in monotherapy in T2DM

Amendment 2 - Protocol Amendme

24/10/2014 12

13/NW/0583/AM03 Evaluation of metformin XR vs metformin IR in monotherapy in T2DM

Amendment 3 12/12/2014 16

13/NW/0612/AM18 Benralizumab treatment in patients with uncontrolled asthma (SIROCCO)

Substantial amendment 9

17/09/2014 7


13/NW/0738/AM02 Humox Study 30/07/2014 31

13/NW/0738/AM02 Humox Study 02 30/07/2014 31

13/NW/0738/AM02 Humox Study Substantial Amendment 02

dated

02/09/2014 31

13/NW/0748/AM01 Clinical trial for elderly patients with Multiple Diseases (CHROMED)V1

One 06/06/2014 16

13/NW/0774/AM04 3623 SUSTAINâ„¢ 1 – Monotherapy SPA03 04/02/2014 28

13/NW/0774/AM06 3623 SUSTAINâ„¢ 1 – Monotherapy NN9535-3632 Substantial Amendm

20/02/2015 20

13/NW/0791/AM02 A Study of GSK1278863 in the treatment of aneamia in Dialysis patients

SA02 21/03/2014 10

13/NW/0791/AM03 A Study of GSK1278863 in the treatment of aneamia in Dialysis patients

SA03 04/11/2014 28

13/NW/0793/AM02 A study of GSK1278863 in the treatment of anaemia in non dialysis.

SA02 21/03/2014 10


SA03 15/05/2014 26


SA04 04/11/2014 28

13/NW/0831/AM11 CV - Long-term Safety of Naldemedine for the Treatment of OIC

20

13/NW/0831/AM11 CV - Long-term Safety of Naldemedine for the Treatment of OIC

07/08/2014 20

13/NW/0858/AM01 AEGEAN study CV185220 v3.0 23 Jan 2013 Amendment 1 26/07/2013 12

13/NW/0858/AM03 AEGEAN study CV185220 v3.0 23 Jan 2013 Substantial Amendment - Set-

up

10/12/2014 34

13/NW/0864/AM01 Investigating a low carbohydrate/high protein diet in type 2 diabetes

Amendment 1 12/03/2014 17


Amendment 4 14/10/2014 13

14/NW/0017/AM03 TERI-PRO 2 20/06/2014 13

14/NW/0018/AM01 Cinryze in Prevention of Angioedema Attacks in Children 02/06/2014 5

14/NW/0156/AM01 OlympiAD - Olaparib monotherapy V Physicians choice chemotherapy

22/06/2014 10



1 22/06/2014 10


Amendment 2 04/07/2014 32


17/09/2014 24

14/NW/0211/AM03 XENIC: The effects of XEN-D0501 on cough frequency in chronic cough

Substantial Amendment -

Urgent

10/12/2014 28

14/NW/0302/AM02 BOTOXÂ® for Treatment of Urinary Incontinence in patients 12-17 yrs old

01/08/2014 15

14/NW/0302/AM03 BOTOXÂ® for Treatment of Urinary Incontinence in patients 12-17 yrs old

Substantial Amendment 2

17/10/2014 19

14/NW/0350/AM01 Nivolumab or Nivolumab + Ipilimumab vs Bevacizumab in Recurrent GBM

1 02/09/2014 19


Substantial Amendment CA03-

EC0

26/11/2014 8


Substantial Amendment EC03

26/01/2015 7

14/NW/0355/AM02 Safety, Tolerability and Efficacy Study of Pneumococcal Vaccine


17/10/2014 9

14/NW/1015/AM01 Copper (II) Chelation therapy in the treatment of HCM Substantial Amendment 1

26/02/2015 20

14/NW/1188/AM01 The validity of informed consent for inguinal hernia surgery Substantial Amendment 1

10/12/2014 28

14/NW/1206/AM01 EAGLE 1 23/02/2015 22

14/NW/1227/AM01 A Phase III study of BAY 81-8973 in children with severe haemophilia A


15/01/2015 18

14/NW/1239/AM01 Guselkumab in Psoriasis following inadequate Ustekinumab response

Amendment 1 11/03/2015 26

14/NW/1292/AM01 CA209-214 Nivolumab combined with Ipilimumab versus Sunitinib in RCC

CA209214 05/11/2014 13

14/NW/1358/AM01 SELINEXOR COMPARED TO PHYSICIANS CHOICE IN RELAPSED OR REFRACTORY AML

KCP 330 008 19/01/2015 15

14/NW/1474/AM01 Antimicrobial Hernia Repair Device Clinical Study 13-10 Substantial Amendment A_01

06/02/2015 15


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

15/NW/0055/AM01 ReFLeCT Substantial Amendment 1

13/02/2015 11

Unfavourable opinion



08/H1002/97/AM01 Immunity to respiratory tract pathogens 1 20/04/2014 12

12/NW/0814/AM06 Efficacy & Safety/Tolerability of Subcutaneous SCH900222/MK-3222

Protocol Amendment 5

30/10/2014 19

13/NW/0612/AM11 Benralizumab treatment in patients with uncontrolled asthma (SIROCCO)

7 17/06/2014 29


27/06/2014 35

14/NW/0015/AM01 Leg length Equalisation, Gait and MUSCLE (The LEG MUSCLE study)

LLD Study - Full Protocol V2 d

09/01/2015 13

14/NW/0143/AM01 The analysis of the faecal microbiome in inflammatory bowel disease


20/10/2014 28

Favourable opinion timeline



11/NW/0555/AM03/2

Family Focused Therapy for BD: A Clinical Case Series. Version 1.0

Amendment 2 - Version 3.1

28/04/2014 11

12/NW/0814/AM06/1

Efficacy & Safety/Tolerability of Subcutaneous SCH900222/MK-3222

Modified Amendment -

Protocol

3

13/NW/0612/AM11/1

Benralizumab treatment in patients with uncontrolled asthma (SIROCCO)

Revised substantial amendment

30/07/2014 6

13/NW/0864/AM02/1

Investigating a low carbohydrate/high protein diet in type 2 diabetes

19/08/2014 7

The analysis of the faecal microbiome in inflammatory bowel Modified 27/01/2015 0


14/NW/0143/AM01/1 disease Amendment 1

Unfavourable opinion timeline




Table 11: Items exceeding timelines

Full applications for ethical review over 60 day timeline


Proportionate review applications for ethical review over 14 day timeline


14/NW/1181 Is Skype an acceptable tool to follow-up liver cancer patients? 18

14/NW/1188 The validity of informed consent for inguinal hernia surgery 16

SSAs (non Phase 1) over 25 day timeline


SSAs (Phase 1) over 14 day timeline


Substantial Amendments over 35 day timeline



Modified Amendments over 14 day timeline




Documents

RES Committee North West - Liverpool East Annual Report 01 ... · Mr Alex Newgrosh None 16/01/2015 Professor Neil Pender None 16/10/2014 Miss Kimberley Saint I sit on the Trustees