RES Committee East of England - Cambridge Central Annual ... · RES Committee East of England - Cambridge Central Annual Report 01 April 2014 - 31 March 2015 . ... September 12/09/2014

Research Ethics Service

RES Committee East of England - Cambridge Central

Annual Report

01 April 2014 - 31 March 2015

RES Committee East of England - Cambridge Central Annual Report Page 2

Part 1 – Committee Membership and Training

Name of REC: RES Committee East of England - Cambridge Central

Type of REC: RECs recognised to review CTIMPS in healthy volunteers - type i, RECs recognised to review CTIMPS in patients - type iii

Type of Flag: Establishing Research Databases, Establishing Research Tissue Banks, Medical Device Study, Phase 1 Studies in Healthy Volunteers, Research Involving Adults Lacking Capacity

Chair: Mrs Carolyn Read until 01/01/2015 Dr Lydia Drumright from 01/01/2015

Vice-Chair: Dr Joseph Cheriyan

Alternate Vice-Chair: Reverend Derek Fraser

REC Manager: Miss Jessica Parfrement

REC Assistant: Miss Georgia Copeland

Committee Address: The Old Chapel Royal Standard Place Nottingham NG1 6FS

Telephone: 0115 8839 440

Email: [email protected]

mailto:[email protected]


Chair’s overview of the past year:

This has been a busy year for the Committee with each meeting averaging at least five applications. All meetings have been quorate and we continue to review a full quota of wide ranging projects, reflecting the large number of flagging held by the Committee and experience of its members. I am pleased to report that all applications were reviewed within 60 days and that the average time to a final decision was 30 days which reflects the hard work and commitment shown by Committee members. As a consequence of the large number of full applications reviewed, the number of studies reviewed under the proportionate review system has been relatively low. The Committee itself has seen several changes in membership this year with the resignation of the Chair Carolyn Read. Dr Lydia Drumright, who transferred to the Committee in September, is the new Chair. We also welcomed Dr Adam McGeoch and Dr Mary-Beth Sherwood to the Committee. I would like take this opportunity to thank Jessica Parfrement and Georgia Copeland at the Nottingham REC office for all their efforts over the past year and welcome the new coordinator’s for this committee. Finally, I would like to thank all the Committee members for their dedication, help and advice during what, I know, has been a very busy year for everyone.


NRES Committee East of England - Cambridge Central Membership

NRES Committee East of England - Cambridge Central: Co-opted Members

Name Profession Expert or

Lay

Dates

Appointed Left

Dr Joseph Cheriyan Consultant Physician Expert 20/05/2011

Ms Anita Chhabra Clinical Trials Pharmacist Expert 01/04/2011

Dr Lydia Drumright University Lecturer in Clinical Informatics

Expert 01/09/2014

Revd Dr Derek Fraser Chaplain Lay Plus 01/04/2011

Dr Adrian French Retired General Practitioner

Expert 01/04/2011

Mr Stuart Kent Retired Consultant Surgeon

Expert 01/04/2011

Miss Giselle Kerry Data Access and Regulatory Support Officer

Lay 12/07/2013

Mr David Lewin Retired Research Officer Expert 01/04/2011

Ms Moira Malfroy Retired Senior Research Nurse/Clinical Trial Manager

Lay 12/06/2013

Dr Adam McGeoch Academic Clinical Lecturer Expert 17/02/2015

Mrs Beth Midgley Lay Member Lay 04/01/2011

Dr Nothando Buhlebenkosi Ngwenya

Research Associate Expert 01/11/2012

Dr Ian Nimmo-Smith Statistician Expert 01/04/2011

Ms Polly Page Operations Director Lay Plus 01/01/2012

Dr Sumantra Ray Senior Medical Advisor/Scientist

Expert 01/01/2012

Mrs Carolyn Read External liaison and Research Governance Officer

Lay Plus 01/04/2011 01/01/2015

Mrs Caroline Saunders Nurse Expert 01/04/2011

Dr Mary-Beth Sherwood Clinical Researcher Lay 15/04/2014

Name Profession Status Meeting date attended

Rebecca Harmston Lay Member Lay Plus December 2014 via teleconference

https://www.harp.org.uk/Member/Contacts/Edit/10433787


NRES Committee East of England - Cambridge Central: Members’ Declarations of Interest:

Name Declaration of Interest Date

Dr Joseph Cheriyan Works for GSK undertaking Phase1/2 trials, but doesn't receive shares. Also sits on the Cambridge Central Clinical Trials Unit Management Board, and also the director of Cambridge Clinical Trials Office

11/12/2014

Ms Anita Chhabra Member of the accredited Cambridge CTU-Cancer, Member of the local Oncology R&D committee

21/01/2015

Dr Lydia Drumright University Lecturer at the University of Cambridge, Department of Medicine conducting ethically approved research studies involving humans as a regular part of my position.

12/12/2014

Revd Dr Derek Fraser UKBHC – board for healthcare chaplaincy 23/01/2015

Ms Fatima Hussain None declared 07/03/2015

Miss Giselle Kerry employee of Sanger Institute 21/01/2015

Mr David Lewin None declared 10/12/2014

Ms Moira Malfroy Has shares in Astra Zeneca and GSK, member of the charity primary Immunodeficiency

24/01/2015

Dr Ian Nimmo-Smith None declared 10/12/2014

Mrs Caroline Saunders Head of Clinical Operations Addenbrookes Clinical Research Centre This centre comprises three units where research is conducted on patients and healthy volunteers. Responsible for the management, conduct and staff working within the clinical research facility, where research is conducted on patients and healthy volunteers. Member of the Scientific Advisory Board for the NIHR Clinical Research Facility, on rare occasions may be asked by an investigator to undertake Peer Review for a project. Member of the NIHR Cambridge Biomedical Research Centre (BRC) Executive Committee which oversees research programmes funded by NIHR BRC. Not directly involved in research studies conducted on this unit and not named as a research team member or co-investigator.

10/12/2014

Nothando Ngwenya None 27/03/2015

Dr Adam McGeoch None 23/03/2015

Dr Mary-Beth Sherwood None 23/03/2015


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 11/04/2014 9

May 09/05/2014 9

June 13/06/2014 10

August 08/08/2014 9

September 12/09/2014 11

October 10/10/2014 13

November 14/11/2014 9

December 12/12/2014 11

January 09/01/2015 13

February 13/02/2015 8

March 13/03/2015 10

11 full committee meetings were held during the reporting period.


at Meeting

April 18/04/2014 4

May 16/05/2014 3

June 20/06/2014 3

August 15/08/2014 3

September 19/09/2014 3

October 17/10/2014 3

January 30/01/2015 3

February 27/02/2015 3

March 27/03/2015 3

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


at Meeting

April 04/04/2014 2

April 25/04/2014 2

May 07/05/2014 2

May 23/05/2014 3

June 06/06/2014 3

June 20/06/2014 2

July 11/07/2014 2

July 25/07/2014 2

August 05/08/2014 2

August 22/08/2014 2



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


October 07/10/2014 2

October 24/10/2014 2

November 07/11/2014 2

November 21/11/2014 2

December 05/12/2014 3

December 22/12/2014 2

January 12/01/2015 2

January 19/01/2015 2

January 26/01/2015 2

February 06/02/2015 2

February 20/02/2015 2

March 06/03/2015 2

March 20/03/2015 2

25 sub-committee meetings were held during the reporting period. None


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

Dr Joseph Cheriyan 6

Ms Anita Chhabra 9

Dr. Lydia Drumright 5

Revd Dr Derek Fraser 7

Dr Adrian French 6

Mr Stuart Kent 9

Miss Giselle Kerry 7

Mr David Lewin 9

Ms Moira Malfroy 9

Dr Adam McGeoch 1

Mrs Beth Midgley 6

Dr Nothando Buhlebenkosi Ngwenya 6

Dr Ian Nimmo-Smith 9

Dr Sumantra Ray 3

Mrs Carolyn Read 7

Mrs Caroline Saunders 5

Dr Mary-Beth Sherwood 7

Name Number of

Meetings

Attended


Ms Anita Chhabra 1



Dr Adrian French 1

Mr Stuart Kent 1


Mr David Lewin 3

Ms Moira Malfroy 1

Mrs Beth Midgley 1



Mrs Carolyn Read 3



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

Name Number of

Meetings

Attended


Ms Anita Chhabra 1



Dr Adrian French 3

Mr Stuart Kent 4


Mr David Lewin 3



Mrs Carolyn Read 9



Training 01 April 2014 - 31 March 2015

Name of Member Date Event(s) attended

Dr Joseph Cheriyan 06/10/2014 Research in Vulnerable Participants

Dr Joseph Cheriyan 15/10/2014 Personal Data

Dr Joseph Cheriyan 23/01/2015 HRA Members Regional Training Day

Ms Anita Chhabra 09/05/2014 GCP Refresher Training

Dr Lydia Drumright 06/10/2014 E&D

Revd Dr Derek Fraser 16/03/2015 Personal Data in Research - A Workshop

Miss Giselle Kerry 23/10/2014 E&D Online

Miss Giselle Kerry 27/01/2015 How do We Improve Health without Betraying Confidentiality

within Current and Upcoming EU Regulations

Mr David Lewin 06/11/2014 Researcher training day

Mr David Lewin 23/01/2015 HRA Members Regional Training Day

Ms Moira Malfroy 12/02/2015 Adults Lacking Capacity

Dr Sumantra Ray 04/04/2014 Information security

Dr Sumantra Ray 01/07/2014 Data protection in research

Dr Sumantra Ray 05/10/2014 HTA


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 6 10.34

Phase 1 4 6.90

Gene Therapy 0 0.00

Research Tissue Bank (including renewals) 0 0.00

Research Database (including renewals) 2 3.45

Others 46 79.31

Total Applications Reviewed 58 100

Number of applications made invalid by the REC Manager 5

Number of applications withdrawn prior to the meeting 1

Number of student applications reviewed 16

Number of paediatric applications reviewed 6

Number of device applications reviewed 23

Number of prisoner applications reviewed 0

Number of applications involving adults unable consent reviewed 9

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

Number of qualitative applications reviewed 2

Decisions taken at meetings following review of

applications

Number %

Favourable Opinion with Standard Conditions 10 17.24

Favourable Opinion with Additional Conditions 5 8.62

Unfavourable Opinion 5 8.62

Provisional Opinion 38 65.52

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

29 50.00

Further Information Favourable Opinion with Additional Conditions

9 15.52

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 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 7

Number of studies withdrawn prior to the meeting 2

Number of student applications reviewed 7

Number of paediatric applications reviewed 1

Number of device applications reviewed 0

Number of qualitative applications reviewed 1

Total Applications Reviewed 15

Decisions taken at proportionate review sub-

committee meetings

Number %



No Opinion transfer to full committee for review 1 6.67



Total 15 100


Table 8: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting 5.27

Number of applications for full ethical review 58

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 9

Number of applications over 40 days as a % of total 15.52%

Number of days taken to final decision – average (mean) 30

Number of proportionate review applications for ethical

review

14

Number of proportionate review applications for ethical

review over 14 days

1

Number of proportionate review applications over 14 days as

a % of total

7.14%

Number of SSAs (non-Phase 1) reviewed 2

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 3

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 154

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

0.65%

Number of modified amendments reviewed 12

Number of modified amendments over 14 days 1

Number of modified amendments over 14 days as a % of

total modified amendments

8.33%

Number of minor amendments received 71

Number of substantial amendments received for information 0

Number of substantial amendments received for new

sites/PIs

14

Number of annual progress reports received 181

Number of safety reports received 21

Number of Serious Adverse Events received 2

Number of final reports received 23

NRES Committee East of England - Cambridge Central Research Ethics Committee Annual Report Page 15

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/EE/0191 EVOLVE 24

14/EE/0193 Adjuvant benefit of NMES to Supervised Exercise in IC 27

14/EE/0202 Imaging Oxytocin and Autism 26

14/EE/0218 GLP-Â1 loading during elective PCI (GOLD-ÂPCI) 30

14/EE/1024 Rheolytic Thrombectomy For Adult Intraventricular Haemorrhage (rtIVH) 23

14/EE/1041 The Influence of Vestibular Processing on Human Cognition 22

14/EE/1051 OPEN study, Revision B, Amendment 03 27

14/EE/1096 FABRY SRT MONO 31

14/EE/1113 TOPAZ 27

14/EE/1118 Retinal biomarkers for Alzheimer's disease in Down's syndrome 45

14/EE/1123 Enterococcus faecium hospital/farm/environment study 44

14/EE/1138 PROCO 58

14/EE/1164 Information and Risk Modification Trial (INFORM) 39

14/EE/1234 PK, Tolerability of CNV1014802 in healthy young & elderly subjects 26

14/EE/1273 Neutrophils distribution in lungs in health and COPD 43

14/EE/1279 Latella-2 28

14/EE/1282 The ANSeR Clinical Investigation 30

14/EE/1292 Obs study liver transplanted patients given Zutectra &/or Hepatect CP 34

15/EE/0002 Transition between inpatient mental health ward and community life 39

15/EE/0004 The modulatory role of serotonin in model-based and model-free choice 39

15/EE/0005 Thora-3Di Respiratory Rate Validation 34

15/EE/0033 A new dementia screening test for people with Learning Disabilities 41

15/EE/0047 AHE02 - PHADER 39

15/EE/0049 Generation of iPS Cells and Rare Diseases 44

15/EE/0059 Transition Preparation Programme (TPP) 48

15/EE/0073 HGUS Study 28

15/EE/0092 BIOmarkers in DEPression (BIODEP) 47

15/EE/0094 Measuring circulating tumour DNA in glioma patients 45




14/EE/0109 ECCO2R in AECOPD 31

14/EE/0115 CHIC FM 38

14/EE/0119 Safety, Tolerability and PK of MAD of ASP7962 in Healthy Subjects 28

14/EE/0145 BEHOLD v1.0 26

14/EE/0165 Near Infra-Red Spectroscopy in Traumatic Brain Injury 29

14/EE/0173 Antibody-mediated rejection in liver transplantation 30

14/EE/1144 Gen2 Hardware Submission for CL-SVT-002 27

14/EE/1224 SADAL: Selinexor and Dexamethasone in Aggressive Lymphoma 31

14/EE/1278 The culture of healthcare 38

Favourable Opinion with Standard Conditions


14/EE/0082 COSMIClinical 27

14/EE/0127 Real Time continuous glucose monitoring in the newborn 27

14/EE/0164 Evaluation of Powered Wheelchair with collision avoidance 21

14/EE/0177 C&I Research Database 24

14/EE/1014 Pilot study of tremor disruption in Parkinson’s Disease 19

14/EE/1044 PK & Immunogenicity of BS-503a (AVA-1) vs. Avastin in healthy subjects 12

14/EE/1130 Patient experiences of cognitive assessment for suspected dementia 24

14/EE/1172 Cambridge Prostate Biopsy DevicE: CAMPROBE 19

14/EE/1178 The effect of walking on recovery following total hip replacement. 24

14/EE/1204 CD0104 VEST II Post Marketing Surveillance Study - resubmission 19

Favourable Opinion with Additional Conditions


14/EE/0140 Vancomycin and HDF Version 1.0 25/2/14 21

14/EE/0147 Cognitive processes and social anxiety in adults with ASD 28

14/EE/0149 Investigating the effects of cognitive training on attention 21

14/EE/1143 Automated 3D overlay for X-ray guided surgery 24

15/EE/0090 First in human study of anti-OSM monoclonal antibody (GSK2330811) 26


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

Unfavourable Opinion


14/EE/1046 Randomised comparison of modified and conventional iv cannulae V1 14

14/EE/1106 CD0104 VEST II Post Marketing Surveillance Study 26

14/EE/1119 Neurodevelopmental outcomes in women with PCOS and their children 26

14/EE/1238 Validation of Structured Light Plethysmography 19

14/EE/1242 Venogram vs. IVUS for Diagnosing Iliac Vein Obstruction (VIDIO) 19



14/EE/0172 Adolescent Asthma Study 13

14/EE/0206 Breath Freshening Effects of Mechanical Removal of Tongue Biofilm 10

14/EE/1088 Effect of Vitamin D on Iron Availability and Inflammation 16

14/EE/1089 Patients experience of symptoms between top-ups sessions of PTNS v1.1 8

15/EE/0044 Has access to sport improved following the Paralympics 10

15/EE/0046 Exploring patients' perspective- core outcomes for AMD studies v.1 14

15/EE/0085 NGAL as biomarker of renal damage in patients with ureteric colic V1.0 14



14/EE/1029 Walking paths following stroke 6

14/EE/1166 ASATs and GRSSA 11

Favourable Opinion with Standard Conditions


14/EE/0207 Views of women volunteering to provide eggs for mitochondrial research 11

14/EE/1207 Factorial validity of the NREQ 10

15/EE/0140 Hepatic artery mapping by CT angiography, cone beam CT and DSA. 11

15/EE/0144 Hip impact dynamics - version 1 11

15/EE/0147 Biomarkers associated with abdominal aortic aneurysmal disease 11


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

01/149 A study to investigate the cell biological determinants of the develop 8 04/07/2014 17

03/018/AM13 Evaluation of biomarkers in urological diseases 12 18/06/2014 20

03/303 Genetic and metabolic abnormalities in neurodegenerative disorders of

12 08/09/2014 18


11 17/07/2014 14


13 31/10/2014 14

96/085 Invitro studies of postmortem human foetal neural tissue 10 13/10/2014 17

96/085 Invitro studies of postmortem human foetal neural tissue 10 13/06/2014 12

00/327 Segregating concurrent sounds in acoustic and electric hearing. 8 18/04/2014 28

01/149/AM07 A study to investigate the cell biological determinants of the develop Substantial Amendment 9

12/02/2015 10

03/018/AM11 Evaluation of biomarkers in urological diseases 10 12/03/2014 22

03/104/AM07 Relationships between energy intake energy expenditure autonomic ner

7 03/02/2015 17

03/302/AM10 Risk patterns and processes for affective psychopathology 8 07/04/2014 20

04/Q0108/190/AM05

Neuroimaging of reward processing 9 29/05/2014 23

04/Q0108/44/AM16 The Cambridge BioResource 18 10/04/2014 14




05/Q0108/262/AM11

The time-course and determinants of arterial stiffening Substantial Amendment 6

16/10/2014 12

05/Q0108/30/AM09 Bodily sample collection for use in method development Amendment 9 24/04/2014 14

06/Q0108/213/AM03

Evaluating biomaterials for tissue engineering 3 09/12/2014 14

The epigenetic and genetic changes in colorectal neoplasia Substantial 18/08/2014 21


06/Q0108/307/AM10 Amendment 6

06/Q0108/38/AM05 fMRI investigation of prefrontal cortex during response selection 1 17/11/2014 21

06/Q0108/39/AM02 fMRI case studies of movement and cognition 1 17/11/2014 21

08/H0308/153/AM28 Genes and Phenotypes in Type 1 Diabetes 04/09/2014 21

08/H0308/176/AM07 Genetic variation AND Assessment of Leucocyte Function (GANDALF)

Substantial Amendment 5

25/09/2014 18

08/H0308/331/AM06 Cerebrospinal Fluid markers of Neurodegenerative Disorders 4.0 14/03/2014 24

08/H0308/331/AM07 Cerebrospinal Fluid markers of Neurodegenerative Disorders 5.0 13/06/2014 10

09/H0308/118/AM10 Trimodal Imaging and Molecular Endpoints Substantial Amendment 7

02/02/2015 13

09/H0308/119/AM11 Eosinophil Kinetics and Movement in Humans Substantial Amendment

10

13/10/2014 15

09/H0308/125/AM08 Optical imaging and EEG in the neonatal and infant brain 8 31/03/2014 27

09/H0308/127/AM09 Heart Outcomes Prevention Evaluation (HOPE) - 3 (version 1.6.1) 5 20/03/2014 27

09/H0308/133/AM02 Shunt in bronchiolitis 002 02/05/2014 26

09/H0308/137/AM12 RCT of treatments in moderate-severe adolescent depression 11 07/04/2014 19

09/H0308/163/AM02 Neurodegenerative disorders 1 2 16/06/2014 10

09/H0308/24/AM01 The study of Human Gut Hormones 1 17/11/2014 7

10/H0308/34/AM02 Understanding cognition and action in Parkinson’s disease 2 01/09/2014 19

10/H0308/56/AM09 Cambridge Brain Bank a Division of Cambridge University NHS Foundation

Substantial Amendment

13/01/2015 12

10/H0308/71/AM13 Evaluation of a Non-Endoscopic Device for Barrett's Oesophagus-BEST 2

12 14/03/2014 24

10/H0308/71/AM15 Evaluation of a Non-Endoscopic Device for Barrett's Oesophagus-BEST 2

13 26/03/2014 11

10/H0308/84/AM03 START 2 26/03/2014 7

10/H0308/84/AM04 START 3 16/06/2014 7

10/H0308/84/AM05 START Substantial Amendment

22/10/2014 11

11/EE/0007/AM06 CAM-SAFE v1.0 3 18/09/2014 15

11/EE/0037/AM07 Validation of Structured Light Plethysmography against spirometry 0004 22/04/2014 14

11/EE/0112/AM01 Using human retinal explant cultures to study novel glaucoma therapies

1 20/07/2014 8

11/EE/0202/AM09 CR UK Stratified Medicine Pilot study 09 18/06/2014 17

11/EE/0202/AM10 CR UK Stratified Medicine Pilot study 10 07/01/2015 17


11/EE/0210/AM07 CL002_168 ANCA-Associated Renal Vasculitis 5 (Protocol Amendment

3.0

11/06/2014 14

11/EE/0226/AM10 DiPALS - Diaphragm pacing in motor neurone disease 10 09/06/2014 14

11/EE/0226/AM11 DiPALS - Diaphragm pacing in motor neurone disease Substantial Amendment

11

27/06/2014 13

11/EE/0226/AM12 DiPALS - Diaphragm pacing in motor neurone disease Substantial Amendment

12

04/09/2014 12

11/EE/0330/AM03 Phenotypes in Intellectual Disability 2 12/11/2014 20

11/EE/0362/AM01 An Investigation of the Prenatal Mother-Father-Child Relationship (v1)

1 23/04/2014 13

11/EE/0362/AM02 An Investigation of the Prenatal Mother-Father-Child Relationship (v1)


03/11/2014 10

11/EE/0381/AM06 Hormones and biomarkers in people with and without ASC Substantial Amendment 3

10/09/2014 16

11/EE/0421/AM02 A genomic study in Ghana, Kenya and Nigeria 2 12/12/2014 12

11/EE/0458/AM05 An Investigation of the neural correlates of avoidance learning in OCD

Substantial Amendment Number 2

15/07/2014 13


5 20/10/2014 6

11/EE/0463/AM02 Interrogating Energy Metabolism in the Human Brain Substantial Amendment 1

17/02/2015 9

11/H0308/13/AM03 Comparative analyses in HPV-associated neoplasias 2 02/04/2014 24

12/EE/0006/AM06 Phase 2 study in patients with metastatic colorectal cancer 7 25/03/2014 12

12/EE/0006/AM07 Phase 2 study in patients with metastatic colorectal cancer 8 04/06/2014 21

12/EE/0092/AM06 Eculizumab in antibody-mediated rejection in DD kidney transplant 02 12/08/2014 23

12/EE/0094/AM01 Development of models to predict survival in intestinal failure Substantial Protocol

Amendment

13/01/2015 13

12/EE/0096/AM06 TransEUro Transplant Study Substantial Amendment

6.0

19/09/2014 7

12/EE/0249/AM09 Mitochondrial function in Down's syndrome 8 24/11/2014 12


12/EE/0249/AM10 Mitochondrial function in Down's syndrome 9 20

12/EE/0250/AM07 U-Change v1.0 5 21/03/2014 12

12/EE/0253/AM04 Assessment of donor pancreas quality: suitability for transplantation Substantial Amendment 4

06/06/2014 11

12/EE/0253/AM05 Assessment of donor pancreas quality: suitability for transplantation 4 10/11/2014 10

12/EE/0349/AM04 BriTROC1: Sample collection study in recurrent HGSOC 4 06/10/2014 21

12/EE/0355/AM03 Dynamics of free cortisol during surgical and medical stress v1.0 3.0 24/04/2014 27

12/EE/0368/AM05 Adrenal study 2 03/11/2014 21

12/EE/0407/AM02 Research database for Cambridgeshire & Peterborough NHS FT (CPFT)

1 16/11/2014 16

12/EE/0486/AM05 Genetic influences on pain perception in chronic pain states 4.0 10/04/2014 14



12/EE/0516/AM01 Stratification of patients with kidney cancer 1 19/05/2014 23

12/EE/0516/AM02 Stratification of patients with kidney cancer Substantial Amendment 2

19/09/2014 7

12/EE/0519/AM07 Investigating the Effects of Atomoxetine on Brain and Behaviour 7 09/04/2014 18

12/EE/0519/AM11 Investigating the Effects of Atomoxetine on Brain and Behaviour Substantial Amendment

11

08/09/2014 18

12/EE/0523/AM08 HGS1006-C1100 Phase 3 - Belimumab for Maintenance of Remission in AAV

8 08/05/2014 18

13/EE/0012/AM02 Approaches to earlier detection & intervention in lung cancer-Study1a Substantial Amendment 1

14/09/2014 7

13/EE/0032/AM03 Epoxyeicosatrienoic acids (EETs) and the cardiovascular system 2 18/11/2014 21

13/EE/0047/AM02 Closed-loop insulin delivery in the general ward (ANGIE02) Substantial Amendment 2

04/07/2014 17

13/EE/0047/AM03 Closed-loop insulin delivery in the general ward (ANGIE02) 3 22/01/2015 17

13/EE/0065/AM02 Clinical trial for elderly patients with Multiple Diseases (CHROMED)V1

Substantial Amendment

31/07/14

31/07/2014 25

13/EE/0114/AM03 (May) Has electrical sinus translated effective remodelling (HESTER) 1 14/04/2014 27

13/EE/0114/AM05 (May) Has electrical sinus translated effective remodelling (HESTER) 3 03/12/2014 16

13/EE/0169/AM01 MesobanK 1 20/04/2014 16

13/EE/0226/AM03 The GSTT/KCL BioResource 02 10/04/2014 8

13/EE/0227/AM04 Refametinib in combination with sorafenib in RAS mutant HCC 3 29/05/2014 22


13/EE/0251/AM02 Home testing of 24/7 closed-loop in young people with type 1 diabetes

2 31/03/2014 25



15/09/2014 13


4 08/01/2015 27


5 05/03/2015 18

13/EE/0257/AM06 K-5172+ MK-8742+ Ribavirin in Treating Subjects with Genotype 2,4,5, a

06 08/04/2014 14

13/EE/0258/AM01 Blood Glucose Performance Test (ADC-PMS-GLU-12014), version 1.0

1 30/10/2014 14

13/EE/0282/AM01 Why does Clozapine cause weight gain? 1 15/04/2014 12

13/EE/0321/AM02 Closing the loop in adults with type 1 diabetes 02/05/2014 18

13/EE/0339/AM06 COMPASS (BAY 59-7939/15786) Substantial Amendment

09/07/2014 11

13/EE/0339/AM07 COMPASS (BAY 59-7939/15786) 004 09/09/2014 20

13/EE/0368/AM02 Dietary n-3 PUFAs and the response to adalimumab in Crohn's disease

Protocol Amendment

7.8

09/10/2014 6

13/EE/0395/AM01 The Research Tissue Bank, Huntingdon Life Sciences 1 05/09/2014 18

13/EE/0408/AM01 Dipole Density Mapping in Supraventricular Tachycardia (CL-SVT-002)

Substantial Amendment 30.06.2014

30/06/2014 8

13/EE/0435/AM01 The role of microRNAs in Kidney Disease (version 1) 1 04/07/2014 4

14/EE/0004/AM02 Fun and Fit Norfolk (Version 1) Substantial Amendment 2

07/08/2014 18

14/EE/0004/AM03 Fun and Fit Norfolk (Version 1) Substantial Amendment 3

08/08/2014 24

14/EE/0007/AM01 Barts Cardiovascular Tissue Bank Substantial Amendment version 6.0

11/08/2014 14

14/EE/0019/AM01 The VISION study 1 05/06/2014 20

14/EE/0019/AM02 The VISION study Substantial Amendment 2

26/09/2014 7

14/EE/0019/AM03 The VISION study 3 16/12/2014 6


14/EE/0031/AM01 Catheter ablation of typical right atrial flutter under MR guidance 1 03/03/2014 19



14/EE/0052/AM01 LINKED Substantial Amendment 06.11.2014

06/11/2014 10

14/EE/0109/AM01 ECCO2R in AECOPD 1 08/12/2014 13

14/EE/0119/AM04 Safety, Tolerability and PK of MAD of ASP7962 in Healthy Subjects 1 18/12/2014 21

14/EE/0119/AM05 Safety, Tolerability and PK of MAD of ASP7962 in Healthy Subjects 2 03/02/2015 23

14/EE/0127/AM01 Real Time continuous glucose monitoring in the newborn Amendment AM01

28/04/2014 18

14/EE/0145/AM01 BEHOLD v1.0 Substantial Amendment 1

25/10/2014 16

14/EE/0147/AM01 Cognitive processes and social anxiety in adults with ASD 1 29/04/2014 26

14/EE/0147/AM02 Cognitive processes and social anxiety in adults with ASD Substantial Amendment 2

22/08/2014 14

14/EE/1041/AM01 The Influence of Vestibular Processing on Human Cognition Substantial Amendment 1

26/09/2014 10

14/EE/1041/AM02 The Influence of Vestibular Processing on Human Cognition Substantial Amendment 2

16/01/2015 7

14/EE/1044/AM01 PK & Immunogenicity of BS-503a (AVA-1) vs. Avastin in healthy subjects

1 01/10/2014 5

14/EE/1044/AM02 PK & Immunogenicity of BS-503a (AVA-1) vs. Avastin in healthy subjects

2 17/11/2014 21

14/EE/1051/AM01 OPEN study, Revision B, Amendment 03 1 19/02/2015 9

14/EE/1096/AM01 FABRY SRT MONO Substantial Amendment 1

24/10/2014 21

14/EE/1096/AM02 FABRY SRT MONO 002 03/01/2015 7

14/EE/1113/AM02 TOPAZ Substantial Amendment 1

27/10/2014 18

14/EE/1118/AM01 Retinal biomarkers for Alzheimer's disease in Down's syndrome 1 15/12/2014 25

14/EE/1118/AM02 Retinal biomarkers for Alzheimer's disease in Down's syndrome Substantial Amendment 2

26/01/2015 14

14/EE/1144/AM03 Gen2 Hardware Submission for CL-SVT-002 Substantial Amendment

9.06.14

09/06/2014 24


14/EE/1164/AM01 Information and Risk Modification Trial (INFORM) Substantial Amendment

#1

02/02/2015 21

14/EE/1224/AM01 SADAL: Selinexor and Dexamethasone in Aggressive Lymphoma Substantial Amendment 11.02.2014

11/02/2015 14

96/085/AM17 Invitro studies of postmortem human foetal neural tissue 12 22/01/2015 14

Unfavourable opinion

Amendment REC

Reference


Clock

02/102/AM02 Functional genomics of schizophrenia and bipolar affective disorder. 3 20/11/2014 13

04/Q0108/23/AM04 Biology of human uterine natural killer cells 4 04/03/2014 18

04/Q0108/290/AM05

Factors controlling myometrial contractility v1 2 23/12/2014 20

11/EE/0037/AM08 Validation of Structured Light Plethysmography against spirometry Substantial Amendment

0005

30/06/2014 8

11/EE/0210/AM10 CL002_168 ANCA-Associated Renal Vasculitis 7 11/02/2015 15



03/09/2014 7

12/EE/0004/AM02 Liquid Biopsy System: safety and performance evaluation 1 23/04/2014 17

12/EE/0096/AM05 TransEUro Transplant Study 5 02/05/2014 21

12/EE/0340/AM05 Diabetes screening & prevention for people with learning disabilities 4 25/11/2014 34

12/EE/0368/AM03 Adrenal study 1 30/04/2014 25




13/EE/0104/AM02 Neuroimaging of Inflammation in MemoRy and Other Disorders (NIMROD) v1

2 26/03/2014 12

13/EE/0429/AM06 BET116183: GSK525762 in Subjects with Haematologic Malignancies

02 14/05/2014 19

14/EE/0007/AM02 Barts Cardiovascular Tissue Bank Substantial Amendment

2#

30/01/2015 20


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

Favourable opinion timeline

Amendment REC

Reference


Clock

04/Q0108/23/AM04/1

Biology of human uterine natural killer cells 4 16/06/2014 10

04/Q0108/290/AM05/1

Factors controlling myometrial contractility v1 2 28/01/2015 14

11/EE/0458/AM06/1 An Investigation of the neural correlates of avoidance learning in OCD Modified Amendmen

t 3

20/10/2014 7

12/EE/0096/AM05/1 TransEUro Transplant Study 5 19/06/2014 8

12/EE/0340/AM05/2 Diabetes screening & prevention for people with learning disabilities 4 19/01/2015 7

12/EE/0519/AM08/1 Investigating the Effects of Atomoxetine on Brain and Behaviour Amendmen

t 8 – revised

15/05/2014 8

12/EE/0519/AM09/1 Investigating the Effects of Atomoxetine on Brain and Behaviour 9 16/06/2014 20

13/EE/0104/AM02/1 Neuroimaging of Inflammation in MemoRy and Other Disorders (NIMROD) v1

10/04/2014 10/04/2014 14

13/EE/0429/AM06/1 BET116183: GSK525762 in Subjects with Haematologic Malignancies 02.1 13/06/2014 14

Unfavourable opinion timeline

Amendment REC

Reference


Clock

11/EE/0210/AM10/1 CL002_168 ANCA-Associated Renal Vasculitis 7 09/03/2015 14

12/EE/0340/AM05/1 Diabetes screening & prevention for people with learning disabilities Modified amendment

06/01/2015 10


4

12/EE/0368/AM03/1 Adrenal study 1 01/07/2014 8


Table 11: Items exceeding timelines

Proportionate review applications for ethical review over 14 day timeline


14/EE/1088 Effect of Vitamin D on Iron Availability and Inflammation 16

Modified Amendments over 14 day timeline

Amendment REC

Reference


Clock

12/EE/0519/AM09/1 Investigating the Effects of Atomoxetine on Brain and Behaviour

9 16/06/2014 20

Documents

RES Committee East of England - Cambridge Central Annual ... · RES Committee East of England - Cambridge Central Annual Report 01 April 2014 - 31 March 2015 . ... September 12/09/2014