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Research Ethics Service

RES Committee South Central - Oxford A

Annual Report

01 April 2014 - 31 March 2015

RES Committee South Central - Oxford A Annual Report

Part 1 – Committee Membership and Training

Name of REC: RES Committee South Central - Oxford A

Type of REC: Recognised Type I, Type III

Type of Flag: Phase 1 in Health Volunteers Phase 1 Studies in Patients Gene Therapy or Stem Cell Clinical trials, Paediatric IRB Registered

Chair: Dr Karen Melham October 2010 - October 2014 Dr John Keen November 2014 – March 2015

Vice-Chair: Dr Cynthia Graham

Alternate Vice-Chair: None

REC Manager: Miss Stephanie MacPherson: April 2014 – April 2015 Miss Lauren Allen: May 2015 – current

REC Assistant: Miss Emma Bell: April 2014 – June 2014 Miss Ruth Avery: July 2014 – September 2014 Steve Mainwairing: September 2014 – February 2015 Mark Dawson: May 2015 – current

Committee Address: Bristol Research Ethics Committee Centre Whitefriars Level 3 Block B Lewins Mead Bristol BS1 2NT

Telephone: 0117 342 1387

Email: [email protected]


Chair’s overview of the past year:

I found an efficient, erudite and effervescent committee when I acted as a stepping stone between permanent Chairs during 2014/15, undertaking consistently strong ethical review sometimes within challenging accelerated timelines. Well done Oxford A. John Keen Chair (November 2014 – March 2015)


RES Committee South Central - Oxford A Membership

RES Committee South Central - Oxford A: Deputy Members

RES Committee South Central - Oxford A: Co-opted Members

Name Profession Expert or

Lay

Dates

Appointed Left

Ms Raj Bains Pharmacovigilance Business Consultant

Lay Plus 29/05/2008

Ms Jane Cheeseman Research Nurse Expert 20/05/2013

Mr Stuart Cole Head of Communications Lay Plus 01/06/2011

Ms Ana de Veciana Clinical Trials Pharmacist Expert 05/02/2015

Ms Alison Eden Manager Patient Recruitment

Lay Plus 01/01/2008 31/12/2014

Mrs Marion Fiddes Consultant Project Manager

Lay Plus 13/02/2006

Dr Cynthia Graham Senior Lecturer in Psychology

Expert 12/12/2005

Mrs Lyndsay Hills Retired Registered Nurse Lay 01/04/2010

Dr Stephanie Jones Postdoctoral Research Scientist

Expert 01/11/2014

Mrs Alison Kealy Legal Assistant – Wills and Probate

Lay Plus 28/05/2013

Dr John Keen GP Expert 01/11/2014 31/03/2015

Ms Joanne Keenan Head of Development Lay 12/05/2014

Mrs Doreen Laity Retired Pharmacist Lay 05/08/2013

Dr Karen Melham Ethicist (Chair) Lay Plus 15/12/2005 27/10/2014

Ms Christine Montague-Johnson

Paediatric Nurse Expert 01/06/2014

Dr Yash Patel Research Project Manager

Expert 01/10/2014 09/02/2015

Dr Mohit Sharma Consultant in Public Health

Expert 29/05/2013

Mr Martin Usherwood Retired Gynaecologist Expert 05/09/2011

Name Profession Status Meeting date attended

Name Profession Status Meeting date attended


RES Committee South Central - Oxford A: Members’ Declarations of Interest:

Name Declaration of Interest Date

Ms Jane Cheeseman None 06/03/2015

Dr Kim Cheetham None 14/11/2014

Mr Stuart Cole None 05/12/2014

Ms Ana de Veciana Husband works for VERTEX Pharmaceuticals ltd Europe and has shares in the company.

21/01/2015

Mrs Marion Fiddes Creative Dementia arts network treasurer 05/12/2014

Dr Cynthia Graham None 05/12/2014

Mrs Lyndsay Hills None 05/12/2014

Dr Stephanie Jones None 05/12/2014

Mrs Alison Kealy Shareholding in GlaxosmithKline 05/12/2014

Dr John Keen None 07/11/2014

Ms Joanne Keenan None 15/05/2014

Mrs Doreen Laity None 05/12/2014


Employed as a Paediatric Research Nurse in the University of Oxford's Department of Paediatrics. Attends the Oxford University Hospitals Trust Trial Safety Group Committee meetings monitoring and reporting adverse events to trials running within the Trust and University.

15/05/2014


Attends the Oxford University Hospitals Trust Trial Safety Group Committee meetings monitoring and reporting adverse events to trials running within the Trust and University.

05/12/2014

Dr Mohit Sharma None 06/03/2015

Mr Martin Usherwood Trustee of Ducklings Trust 10/02/2015


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 04/04/2014 10

May 02/05/2014 8

June 06/06/2014 8

July 04/07/2014 11

August 01/08/2014 10

September 05/09/2014 10

October 03/10/2014 11

November 07/11/2014 11

December 05/12/2014 12

February 06/02/2015 11

February 23/02/2015 8

March 06/03/2015 10

12 full committee meetings were held during the reporting period.


at Meeting

April 25/04/2014 3

May 19/05/2014 3

June 18/06/2014 3

August 15/08/2014 3

September 15/09/2014 3

October 27/10/2014 3

January 26/01/2015 3

March 23/03/2015 3

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


at Meeting

April 11/04/2014 2

April 23/04/2014 2

May 16/05/2014 2

May 30/05/2014 2

June 13/06/2014 2

June 16/06/2014 2

June 27/06/2014 2

July 08/07/2014 2

July 25/07/2014 2

August 01/08/2014 2

August 08/08/2014 2


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

August 22/08/2014 2



October 03/10/2014 2

October 10/10/2014 2

October 23/10/2014 2

October 24/10/2014 2

October 27/10/2014 2

November 03/11/2014 2

November 12/11/2014 2

November 25/11/2014 2

December 12/12/2014 2

December 22/12/2014 3

January 08/01/2015 2

January 20/01/2015 2

January 22/01/2015 2

January 30/01/2015 2

February 06/02/2015 2

February 20/02/2015 2

March 06/03/2015 2

March 13/03/2015 2

32 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

Name Number of

Meetings

Attended

Ms Raj Bains 5

Ms Jane Cheeseman 9

Mr Stuart Cole 7

Ms Alison Eden 7

Mrs Marion Fiddes 7

Dr Cynthia Graham 7

Mrs Lyndsay Hills 9

Dr Stephanie Jones 4

Mrs Alison Kealy 9

Dr John Keen 5

Ms Joanne Keenan 8

Mrs Doreen Laity 9

Dr Karen Melham 6

Ms Christine Montague-Johnson 7

Dr Yash Patel 3

Dr Mohit Sharma 9

Mr Martin Usherwood 9

Name Number of

Meetings

Attended

Ms Jane Cheeseman 2

Mr Stuart Cole 4

Ms Alison Eden 2

Mrs Marion Fiddes 1

Dr Cynthia Graham 3

Mrs Lyndsay Hills 3

Mrs Alison Kealy 1

Dr John Keen 2

Dr Karen Melham 1

Dr Yash Patel 1

Dr Mohit Sharma 1

Mr Martin Usherwood 3


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

Name Number of

Meetings

Attended

Ms Jane Cheeseman 6

Ms Alison Eden 5

Mrs Marion Fiddes 6

Dr Cynthia Graham 11

Mrs Lyndsay Hills 4

Mrs Alison Kealy 1

Dr John Keen 12

Mrs Doreen Laity 1

Dr Karen Melham 16

Dr Mohit Sharma 3


Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Ms Jane Cheeseman 05/09/2014 Oxford A REC Training Day

Mr Stuart Cole 05/09/2014 Oxford A REC Training Day

Ms Alison Eden 05/09/2014 Oxford A REC Training Day

Mrs Marion Fiddes 05/09/2014 Oxford A REC Training Day

Dr Cynthia Graham 05/09/2014 Oxford A REC Training Day

Mrs Lyndsay Hills 05/09/2014 Oxford A REC Training Day

Dr Stephanie Jones 09/03/2015 Induction

Mrs Alison Kealy 05/09/2014 Oxford A REC Training Day

Dr John Keen 20/11/2014 NREAP Training

Ms Joanne Keenan 12/06/2014 NRES Committee Members Induction

Ms Joanne Keenan 04/08/2014 Equality and Diversity - e-learning module

Ms Joanne Keenan 05/09/2014 Oxford A REC Training Day

Ms Joanne Keenan 12/01/2015 CTIMP Training

Mrs Doreen Laity 20/05/2014 Induction

Mrs Doreen Laity 19/08/2014 Equality and Diversity training (e-learning module)

Mrs Doreen Laity 05/09/2014 Oxford A REC Training Day

Dr Karen Melham 05/09/2014 Oxford A REC Training Day


06/08/2014 Equality and Diversity


05/09/2014 Oxford A REC Training Day


25/09/2014 NRES Committee Members Induction


12/03/2015 Assessing the Consequences (benefits and harms) of

Research


16/03/2015 Training - Personal Data in Research - A Workshop

Dr Yash Patel 08/05/2014 Quantitative Research Methods and Statistics: A Health

Research Authority Workshop

Dr Yash Patel 12/09/2014 Human Tissue Act (Use of Human Samples in Research) -

An Introductory Level

Dr Yash Patel 10/11/2014 Qualitative Research and Ethical Review

Dr Mohit Sharma 20/05/2014 NRES Committee Members Induction

Dr Mohit Sharma 05/09/2014 Oxford A REC Training Day


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 17 34.00

Phase 1 6 12.00

Gene Therapy 3 6.00

Research Tissue Bank (including renewals) 0 0.00

Research Database (including renewals) 0 0.00

Others 24 48.00

Total Applications Reviewed 50 100

Number of applications made invalid by the REC Manager 1

Number of applications withdrawn prior to the meeting 1

Number of student applications reviewed 11

Number of paediatric applications reviewed 8

Number of device applications reviewed 0

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 1

Number of qualitative applications reviewed 0

Decisions taken at meetings following review of

applications

Number %

Favourable Opinion with Standard Conditions 2 4.00

Favourable Opinion with Additional Conditions 3 6.00

Unfavourable Opinion 1 2.00

Provisional Opinion 44 88.00

Provisional Opinion Pending Consultation with Referee 0 0.00

Total 50 100

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

31 62.00

Further Information Favourable Opinion with Additional Conditions

12 24.00

Further Information Unfavourable 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 1 2.00

Total 50 100


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 5

Number of studies withdrawn prior to the meeting 1

Number of student applications reviewed 5

Number of paediatric applications reviewed 3

Number of device applications reviewed 1

Number of qualitative applications reviewed 1

Total Applications Reviewed 20

Decisions taken at proportionate review sub-

committee meetings

Number %



No Opinion transfer to full committee for review 1 5.00



Total 20 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 4.17

Number of applications for full ethical review 50

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 1

Number of applications over 40 days as a % of total 2.00%

Number of days taken to final decision – average (mean) 24

Number of proportionate review applications for ethical

review

19

Number of proportionate review applications for ethical

review over 14 days

1

Number of proportionate review applications over 14 days as

a % of total

5.26

Number of SSAs (non-Phase 1) reviewed 11

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 9

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 149

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 1

Number of substantial amendments over 28 days as a % of

total substantial amendments

0.67%

Number of modified amendments reviewed 4

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 101

Number of substantial amendments received for information 2

Number of substantial amendments received for new

sites/PIs

23

Number of annual progress reports received 109

Number of safety reports received 143

Number of Serious Adverse Events received 3

Number of final reports received 53

RES Committee South Central - Oxford A Research Ethics Committee Annual Report

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


REC Reference Title Number of Days on Clock

14/SC/0145 Midbrain changes due to anaesthesia during routine elective surgery 25

14/SC/0153 Effect of bronchoconstriction on airway cellular responses in asthma 25

14/SC/0168 High-resolution connectivity of the basal ganglia in health & disease 31

14/SC/0188 Predictors of outcome after mild traumatic brain injury in children 27

14/SC/0190 HCMR Study 26

14/SC/0195 Evaluation of the Safety of Simultaneous HCV and HIV-1 Immunisations 29

14/SC/0220 First Time in Human Study of the TRPV4 blocker GSK2798745 29

14/SC/0232 MenB vaccine for immunocompromised 20

14/SC/0269 Revo Phase 3: Coagulation Factor VIIa in Congenital Hemophilia A or B 23

14/SC/0281 ExPresSO 20

14/SC/1145 Study to determine the efficacy of XF-73 in eradicating Staph aureus. 19

14/SC/1150 Red cell transfusion and QoL in myelodysplastic syndromes (REDDS) 20

14/SC/1159 CO-OP in children with hyperkinetic movement disorders following DBS 26

14/SC/1160 Molecular Mechanisms of Epidural Related Maternal Fever 20

14/SC/1204 Investigating Enteric Fever 26

14/SC/1231 Vaccination in Prostate Cancer (VANCE), version 1.0 24

14/SC/1278 CHECK AF - Atrial Fibrillation screening study 30

14/SC/1305 Netazepide (YF476) in patients with Barrett's oesophagus; version 1 25

14/SC/1309 The TEMPLATE Study 30

14/SC/1347 Astellas - 8232-CL-0004 - Chronic Kidney & Diabetes Type 2 25

14/SC/1361 Dapagliflozin as an add-on to Insulin Therapy in Type 1 Diabetes 20

14/SC/1362 IAVI LONG TERM FOLLOW-UP STUDY 22

14/SC/1372 RIVER - Research In Viral Eradication of HIV Reservoirs 36

14/SC/1379 Brincidofovir (CMX001) for Treatment of Ebola Virus Disease 5

14/SC/1416 IgNiTE: Immunoglobulin in the treatment of encephalitis 25

15/SC/0023 Catheter Vs Thoracoscopic Surgical Ablation in LSPAF - Multicentre RCT 20

15/SC/0050 Role of ERAP1 in development of cervical cancer (v1) 30

15/SC/0051 Foxweb 21

15/SC/0103 SCALOP-2 V4.0 24Apr2015 28

15/SC/0109 OxLith 28

15/SC/0115 HARMONY Outcomes Trial 28




14/SC/0154 Drug interaction study of ONO-4641 with atenolol or diltiazem 39

14/SC/0170 Phase 3 study to test the effects of SA237 in patients with NMO&NMOSD 26

14/SC/0212 Women's daily activities during pregnancy 31

14/SC/0280 Biomarker Investigation & Study of Pathology in Neuropathy (Bio-SPIN) 22

14/SC/0295 IMPALA trial 29

14/SC/1067 PROMDEP 31

14/SC/1124 RCT of pregnancy outcomes followng PGS versus morphological assessment 48

14/SC/1163 Understanding meningococcal carriage and disease 23

14/SC/1256 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z 10

14/SC/1405 A research study involving imaging patients with rheumatoid arhtritis 27

14/SC/1408 Evaluating Vaccines against Ebola 5

15/SC/0054 CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238 21

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/SC/1333 PATH-2: Platelet Rich Plasma in Achilles Tendon Healing 18

15/SC/0055 Natsal-3: further characterisation of CT and MG specimens 19

Favourable Opinion with Additional Conditions


14/SC/0227 Co-administration of RTS,S and viral vectors expressing ME-TRAP 25

14/SC/1427 Vaccines Against Salmonella Typhi (VAST) 13

15/SC/0108 A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z 5

Unfavourable Opinion


14/SC/1088 Educational intervention for heart failure in emergency department 21


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

Provisional Opinion


Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting


15/SC/0118 Phase II of Pazopanib in patients with advanced soft tissue sarcoma 30



14/SC/0252 A long-term follow-up of adult kidney and liver transplant recipients 10

14/SC/0253 Exploring the Journey to Parenthood 11

14/SC/0254 Qualitative study of attachment narratives in couples therapy 9

14/SC/0286 Validation of Hand 20 Questionnaire 11

14/SC/1062 A qualitative study exploring patients experiences of PPI in research 9

14/SC/1220 Can the Intraocular Pressure be Determined from MRI? 13

14/SC/1275 Growth Assessment of Preterm infants (GAP study) 7

14/SC/1350 CC-4047-MM-015-Pomalidomide for relapsed and refractory MM patients_Ob 16

14/SC/1352 European Paediatric Tuberculosis Database 8

15/SC/0178 MACCE after endoscopic vein harvest for CABG 13

15/SC/0184 PROOF-ABPM 13




14/SC/1061 Prospective post-market evaluation of an echogenic catheter 9

14/SC/1272 DiMaP study - Dialysis Modality and Phosphate study 8

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


14/SC/1064 Candida and the inflammatory response in biopsy samples v1 8

14/SC/1348 Vertebral Fracture: Vertebral Analysis from 2D VFA Scans 11

15/SC/0064 Aflibercept in patients with exudative AMD refractory to ranibizumab 5

15/SC/0186 Proteomics analysis of malignant pleural effusion 8

Favourable Opinion with Additional Conditions


14/SC/1052 Quality of life in children with glaucoma and cataract 6

Unfavourable Opinion


14/SC/1273 Platelet function using TEG in haematology patients Version 1 6

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

04/Q1604/21/AM06 Expression pattern of C-type Lectins Substantial Amendment 10

25/07/2014 12

06/Q1604/162/AM06

Rectal Imaging Trial (RIT) Substantial Amendment 3

21/02/2014 14

07/H0604/113/AM23 National Diet and Nutrition Survey 2008 - 2012 Substantial Amendment 17

04/12/2014 7

07/H0604/122/AM38 A comparison of Insulins Detemir and Glargine in Girls with Diabetes

35 16/05/2014 17

07/Q1604/28/AM04 Immune factors in neurological diseases 2 13/10/2014 26

08/H0604/147/AM02 CHART-ED Substantial Amendment 2

31/03/2014 14

08/H0604/170/AM09 Placebo controlled study of zoledronic acid in osteoporotic children

Substantial Amendment 6

14/03/2014 16


10 14/10/2014 11


Substantial amendment 12

19/12/2014 18



09/02/2015 15

09/H0604/20/AM03 OxBRC Prospective Cohort Study in Hepatitis C virus infection 3 17/10/2014 21

09/H0604/58/AM08 Biomarkers for endometriosis Substantial Amendment 6.0

16/04/2014 18

09/H0604/79/AM24 Myeloma XI 6.0 11/09/2014 18

09/H0604/79/AM27 Myeloma XI Substantial Amendment dated

17

17/12/2014 25

09/H0604/96/AM08 Functional Magnetic Resonance Imaging of Laboratory Dyspnoea


14/02/2014 15

09/H0604/96/AM09 Functional Magnetic Resonance Imaging of Laboratory Dyspnoea


16/06/2014 13

09/H0604/96/AM10 Functional Magnetic Resonance Imaging of Laboratory Substantial 08/07/2014 14


Dyspnoea Amendment 10

10/H0604/13/AM08 Preparatory work for OXTEXT: improved management of healthy volunteers

Version 13 28/05/2014 18

10/H0604/13/AM09 Preparatory work for OXTEXT: improved management of healthy volunteers

6 04/11/2014 10

10/H0604/45/AM14 HCV003_Study of a new MVA vaccine for hepatitis C virus_v1 Substantial Amendment dated

10

10/04/2014 8

10/H0604/45/AM15 HCV003_Study of a new MVA vaccine for hepatitis C virus_v1 Substantial Amendment (HCV003-

17/09/2014 25

10/H0604/45/AM19 HCV003_Study of a new MVA vaccine for hepatitis C virus_v1 Substantial amendment HCV003-1

17/02/2015 21

10/H0604/47/AM14 Phase I Study of IMCgp100 in Advanced Malignant Melanoma V1.0

15 18/08/2014 23

10/H0604/47/AM15 Phase I Study of IMCgp100 in Advanced Malignant Melanoma V1.0


18/12/2014 25

10/H0604/68/AM07 Safety extension study to 3760: Monthly rFXIII replacement therapy


01/04/2014 11

10/H0604/7/AM27 Can We Reduce the Number of Vaccine Injections for Children?


24/06/2014 5

10/H0604/85/AM16 Study of CHOP with Ofatumumab in patients with Richter's Syndrome V1.0


15/07/2014 12

10/H0604/85/AM17 Study of CHOP with Ofatumumab in patients with Richter's Syndrome V1.0

12 31/10/2014 14

10/H0604/91/AM10 COASt - Clinical Outcomes in Arthroplasty Study Substantial Amendment 4

19/02/2014 26

10/H0604/99/AM06 Markers of Neurodegeneration in Multiple Sclerosis Substantial Amendment 2

14/03/2014 19

11/SC/0100/AM05 A DBS study in chronically implanted patients with PD V.1 Substantial Amendment 5

20/05/2014 14

11/SC/0100/AM06 A DBS study in chronically implanted patients with PD V.1 Substantial Amendment 6

10/07/2014 22

11/SC/0149/AM15 V212-011 Study of Safety & Efficacy of V212 in patients with ST or HTM


20/08/2014 9



SA16 V212-011 05/11/2014 21



15/12/2014 8

11/SC/0218/AM02 Measuring motor symptoms in clinical conditions 2 05/11/2014 15

11/SC/0307/AM05 Determinants of Staphylococcus aureus carriage Substantial amendment 2

12/02/2015 26

11/SC/0355/AM06 MBSR in the management of psychological distress in prostate cancer


05/02/2015 13

11/SC/0360/AM15 Magec 0.1 Substantial Amendment 8

06/06/2014 18

11/SC/0409/AM10 VanSel-1: A Phase I trial of Vandetanib and Selumetinib. 11 30/05/2014 18

11/SC/0409/AM11 VanSel-1: A Phase I trial of Vandetanib and Selumetinib. Substantial amendment 13

25/11/2014 17

11/SC/0410/AM04 VIT-0910 Substantial Amendment VIT-

0910

30/01/2014 15

11/SC/0452/AM05 Oral MK8669 in Children/Adolescents with Solid Tumours(6 - <18years)

Substantial Amendment 5 -

21/03/2014 21

11/SC/0498/AM03 Validation of biochemical methods in kidney disease Substantial Amendment 3

05/11/2014 7

12/SC/0014/AM09 Vasopressin vs Noradrenaline as Initial therapy in Septic Shock

6 08/10/2014 18

12/SC/0198/AM14 Cell Bandage (Mesenchymal Stem Cell Therapy) to Treat Meniscal Tears


01/04/2014 16

12/SC/0328/AM10 CANDID 5.0 05/06/2014 24

12/SC/0328/AM11 CANDID Substantial Amendment 6

26/09/2014 13

12/SC/0339/AM06 STUDY OF FOLLOW-UP AND OUTCOMES FOLLOWING ADOLESCENT SEXUAL ASSAULT


16/11/2014 8

12/SC/0339/AM06 STUDY OF FOLLOW-UP AND OUTCOMES FOLLOWING ADOLESCENT SEXUAL ASSAULT


18/11/2014 8

12/SC/0416/AM01 Surveillance of neonatal surgical morbidities 13 08/10/2014 14

12/SC/0429/AM04 Paclitaxel with or without LCL161 in patients with breast cancer 4 13/05/2014 18

12/SC/0527/AM03 215ON201: Study of BIIB033 in subjects with acute optic neuritis


10/04/2014 10


12/SC/0556/AM02 Boosting the therapeutic benefits of prism adaptation using tDCS

1 30/07/2014 25

12/SC/0556/AM03 Boosting the therapeutic benefits of prism adaptation using tDCS


12/02/2015 25

12/SC/0557/AM04 Prism and tDCS Treatment of Complex Regional Pain Syndrome (CRPS)


25/03/2014 14

12/SC/0557/AM05 Prism and tDCS Treatment of Complex Regional Pain Syndrome (CRPS)


01/07/2014 14

12/SC/0559/AM06 Anti-PD-1/Everolimus in Advanced or Metastatic ClearCell Renal Cancer


16/09/2014 12

12/SC/0566/AM05 Rivaroxaban in Antiphospholipid Syndrome (RAPS) Substantial Amendment 3

22/09/2014 13

12/SC/0566/AM06 Rivaroxaban in Antiphospholipid Syndrome (RAPS) Substantial Amendment 4

22/09/2014 20

12/SC/0579/AM06 GreenGeneTM F_P3 (A study in patients with severe Haemophilia A)


01/05/2014 19

12/SC/0616/AM03 ROCOCO: Radiotherapy & olaparib for oesophageal carcinoma


26/08/2014 21

12/SC/0639/AM08 A Phase Ib trial of MVA-EBNA1/LMP2 vaccine in nasopharyngeal carcinoma


17/02/2015 14

12/SC/0650/AM04 The neural basis of temporal expectations in Parkinson's Disease v1.0

Substantial Amendment 1.1

17/07/2014 14

12/SC/0650/AM05 The neural basis of temporal expectations in Parkinson's Disease v1.0

1.3 31/10/2014 14

12/SC/0660/AM04 AdNRGM; VDEPT + GMCSF in locally recurrent prostate cancer


24/10/2014 20

12/SC/0694/AM03 Interferon and proton MRS at 7T Substantial Amendment 3

01/04/2014 14

13/SC/0004/AM04 A phase I study to assess two new influenza vaccine candidates

SA005 20/05/2014 21

13/SC/0098/AM04 TB034:ChAdOx1 85A and MVA85A in BCG vaccinated adults Substantial Amendment 7

17/12/2014 24

13/SC/0173/AM04 Phase III Study in Metastatic Castration Resistant Prostate Cancer

3.0 03/06/2014 10

13/SC/0267/AM04 Pilot Study of Deep Brain Stimulation for Severe Anorexia nervosa


19/01/2015 21


13/SC/0283/AM02 Ovarian Cancer Biomarkers: A Preliminary Study 1 09/09/2014 28

13/SC/0291/AM02 GO28053 Ph1 Vemurafenib in BRAF V600 mutation positive cancer patients

3 13/05/2014 20

13/SC/0317/AM05 IELSG 37 Substantial Amendment 1

01/05/2014 13

13/SC/0322/AM04 Immunotherapy with CD25/71 Allodepleted T-cells (ICAT) Substantial amendment 3

08/12/2014 12

13/SC/0329/AM02 TB035: MVA85A- Homologous boosting by heterologous route Substantial Amendment 4

21/10/2014 24

13/SC/0329/AM03 TB035: MVA85A- Homologous boosting by heterologous route Substantial amendment 05

10/02/2015 13

13/SC/0374/AM02 Phase I, AZD8186 in Patients with CRPC, sqNSCLC, TNBc, PTEN malignancy

2 04/11/2014 10

13/SC/0376/AM02 Cardiac MRI at higher magnetic field strength to assess heart function


14/04/2014 9

13/SC/0383/AM08 MK-8237-009 House Dust Mite Biomarker Study Substantial Amendment 3

21/05/2014 13

13/SC/0383/AM11 MK-8237-009 House Dust Mite Biomarker Study 5 14/10/2014 11

13/SC/0383/AM16 MK-8237-009 House Dust Mite Biomarker Study Substantial amendment 6

05/02/2015 20

13/SC/0387/AM01 Treatment trial of chronic central serous chorioretinopathy Substantial amendment 1

06/02/2015 16

13/SC/0421/AM01 A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults


23/07/2014 20



23/10/2014 22

13/SC/0470/AM03 Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke


19/03/2014 17



24/10/2014 21



15/01/2015 7



06/02/2015 19


13/SC/0510/AM01 RADAR ICU Substantial Amendment 2

10/07/2014 14

13/SC/0544/AM02 PREPARE - Preconceptional diet and embryo quality: an RCT. Substantial Amendment 2

18/06/2014 15

13/SC/0544/AM03 PREPARE - Preconceptional diet and embryo quality: an RCT. 3 23/10/2014 20

13/SC/0544/AM04 PREPARE - Preconceptional diet and embryo quality: an RCT. Substantial amendment 4

19/12/2014 16

13/SC/0558/AM08 Secukinumab in treatment of chronic palmoplantar pustular psoriasis


13/10/2014 8

13/SC/0568/AM06 The ONE Study Cell Therapy Trial Substantial Amendment 2

06/01/2014 2

13/SC/0568/AM09 The ONE Study Cell Therapy Trial 3 21/07/2014 1

13/SC/0568/AM14 The ONE Study Cell Therapy Trial Substantial amendment 4

24/02/2015 14

13/SC/0599/AM05 Parental Responses to Child Experiences of Trauma: PROTECT Study v.1

SA2 05/08/2014 14

13/SC/0604/AM01 Treg Liver Trial Substantial Amendment 4.0

24/02/2014 17

13/SC/0604/AM06 Treg Liver Trial Substantial Amendment 2

21/08/2014 7

13/SC/0604/AM07 Treg Liver Trial Substantial amendment 3

24/11/2014 18

13/SC/0604/AM08 Treg Liver Trial Substantial amendment 4

24/02/2015 19

13/SC/0609/AM01 Measuring synaptic function using EEG and MEG 1 07/11/2014 19

14/SC/0004/AM03 Understanding Paratyphoid Infection Substantial Amendment 1

18/03/2014 14

14/SC/0004/AM06 Understanding Paratyphoid Infection Substantial Amendment 2

11/06/2014 14

14/SC/0004/AM07 Understanding Paratyphoid Infection 3 21/08/2014 20

14/SC/0065/AM01 28431754DIA4003 (CANVAS-R) Substantial Amendment 1

05/05/2014 11

14/SC/0065/AM02 28431754DIA4003 (CANVAS-R) Substantial Amendment 2

27/08/2014 13

14/SC/0077/AM01 Investigating the immune response to 4CMenB in infants(EUCLIDS)2+1


23/04/2014 26


14/SC/0120/AM01 A Study to Assess New Malaria Vaccines ChAd63 RH5 and MVA RH5 (VAC057)


04/07/2014 24



11/08/2014 14


3 10/10/2014 17



25/11/2014 17

14/SC/0170/AM02 Phase 3 study to test the effects of SA237 in patients with NMO&NMOSD

2 27/02/2014 24


3 03/11/2014 23



28/01/2015 12

14/SC/0190/AM03 HCMR Study 1 29/07/2014 24

14/SC/0190/AM05 HCMR Study 2 06/11/2014 19

14/SC/0195/AM01 Evaluation of the Safety of Simultaneous HCV and HIV-1 Immunisations

1 21/08/2014 20



23/10/2014 22



09/02/2015 15

14/SC/0220/AM01 First Time in Human Study of the TRPV4 blocker GSK2798745 Substantial Amendment 03

18/09/2014 20

14/SC/0220/AM02 First Time in Human Study of the TRPV4 blocker GSK2798745 Substantial Amendment 4

24/10/2014 18

14/SC/0220/AM03 First Time in Human Study of the TRPV4 blocker GSK2798745 Substantial amendment 4

05/12/2014 31

14/SC/0227/AM01 Co-administration of RTS,S and viral vectors expressing ME-TRAP

SA001 20/08/2014 21

14/SC/0227/AM07 Co-administration of RTS,S and viral vectors expressing ME-TRAP


10/12/2014 12

14/SC/0232/AM01 MenB vaccine for immunocompromised Substantial Amendment 1

02/09/2014 7

14/SC/0269/AM01 Revo Phase 3: Coagulation Factor VIIa in Congenital Hemophilia A or B

1 01/08/2014 25



2 10/09/2014 19



21/10/2014 24

14/SC/0295/AM03 IMPALA trial 1 03/11/2014 11

14/SC/1052/AM01 Quality of life in children with glaucoma and cataract Substantial Amendment 1

25/06/2014 12

14/SC/1231/AM01 Vaccination in Prostate Cancer (VANCE), version 1.0 Substantial Amendment 1

28/01/2015 11

14/SC/1256/AM01 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial Amendment SA002

02/10/2014 0

14/SC/1256/AM02 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z SA003 22/10/2014 3

14/SC/1256/AM03 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial Amendment 4

31/10/2014 0


24/11/2014 1

14/SC/1256/AM06 A Phase I Study to Assess a New Ebola Vaccine, cAd3-EBO Z Substantial amendment 6

16/01/2015 2


28/01/2015 1

14/SC/1347/AM01 Astellas - 8232-CL-0004 - Chronic Kidney & Diabetes Type 2 Substantial amendment 1

16/01/2015 24

14/SC/1408/AM01 Evaluating Vaccines against Ebola Substantial Amendment 1

18/12/2014 4

14/SC/1408/AM03 Evaluating Vaccines against Ebola Substantial amendment 2

20/01/2015 2

14/SC/1408/AM05 Evaluating Vaccines against Ebola Substantial Amendment 3

21/01/2015 7

14/SC/1408/AM06 Evaluating Vaccines against Ebola 4 03/03/2015 0

15/SC/0108/AM01 A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z

001 27/02/2015 5

Unfavourable opinion

Amendment REC

Reference


Clock

11/SC/0307/AM03 Determinants of Staphylococcus aureus carriage Substantial 08/01/2015 15


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

amendment 1, 25 Se

13/SC/0173/AM08 Phase III Study in Metastatic Castration Resistant Prostate Cancer


02/12/2014 21

13/SC/0374/AM01 Phase I, AZD8186 in Patients with CRPC, sqNSCLC, TNBc, PTEN malignancy

1 29/10/2014 16


SA004 05/03/2015 16

13/SC/0599/AM04 Parental Responses to Child Experiences of Trauma: PROTECT Study v.1


15/04/2013 26

Favourable opinion timeline

Amendment REC

Reference


Clock

12/SC/0051/AM01/2 PRESCRIBE Modified Amendment AM01

01/05/2014 2

13/SC/0173/AM08/1 Phase III Study in Metastatic Castration Resistant Prostate Cancer

Modified Amendment 5

08/01/2015 4

13/SC/0199/AM02/1 Protection against Pneumococcal infection in children with T1DM


26/03/2014 2

13/SC/0599/AM04/1 Parental Responses to Child Experiences of Trauma: PROTECT Study v.1


17/06/2014 1

Unfavourable opinion timeline

Amendment REC

Reference


Clock


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/SC/1350 CC-4047-MM-015-Pomalidomide for relapsed and refractory MM patients_Ob 16

SSAs (non Phase 1) over 25 day timeline


SSAs (Phase 1) over 14 day timeline


Substantial Amendments over 35 day timeline

Amendment REC

Reference


Clock

Modified Amendments over 14 day timeline

Amendment REC

Reference


Clock

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