nres committee london - city & east annual report · lewins mead bristol bs1 2nt telephone:...

NRES Committee London - City & East

Annual Report

01 April 2012 – 31 March 2013

National Research Ethics

Service

NRES Committee London - City & East Annual Report

Part 1 – Committee Membership and Training

Chair’s overview of the past year:

Name of REC: NRES Committee London - City & East Type of REC: REC recognised to review CTIMPS in patients - type iii Type of Flag: IRB Registered

Phase 1 Studies in Patients Research Involving Children

Chair: Dr Arthur T. Tucker

Vice-Chair: Dr Louise Abrams

Alternate Vice-Chair: None

Co-ordinator: Mr Rajat Khullar PRSC Co-ordinator: Mr Rajat Khullar Assistant Co-ordinator: None Committee Address: Bristol Research Ethics Committee Centre

Whitefriars Level 3, Block B Lewins Mead Bristol BS1 2NT

Telephone: 01173421386 Fax: 01173420445 Email: [email protected]

The NRES Committee London - City & East continues to represent the review process fairly, while maintaining the highest level of expectation of the applicants and ourselves. Furthermore, on those occasions where the committee felt a proposal flawed or incomplete we have sought to offer solutions and guidance drawn from the wealth of experience, both clinical and lay. We will continue to do so, as I believe strongly that this approach is appropriate and compliments our primary objectives: i.e. to maintain the safety, welfare and dignity of the patients. We appreciate the continued support and hard work of the entire administrative team, and Raj Khullar in particular. Finally, as with previous years, I am personally very grateful for the regular contributions of the members, without whom there could be no committee, especially one of this calibre which has both national and International recognition. The work is time-consuming, often complex and at times repetitive with little or no reward or recognition from their employers. I am confident that the committee will continue its role with professionalism and sincerity.


NRES Committee London - City & East Membership:

Name Occupation Expert or Lay

Dates

Appointed Resigned

Dr Louise Abrams Pharmacology (Vice Chair)

Expert 01/05/2004

Dr Chandan Alam Experimental Pathology Expert 01/02/2005

Dr Marie E Bardsley Director Lay 17/02/2009

Ms Jane Batchelor Centre Administrator, Advanced Cardiovascular Imaging

Lay Plus 01/12/2011

Dr Ayse Baxter Independent Consultant Pharmaceutical Physician

Expert 01/07/2007

Mr Frank Cross Consultant General and Vascular Surgeon

Expert 13/11/2008

Dr Miran Epstein Senior Lecturer Medical Ethics

Expert 01/05/2004

Ms Janelle Hill Non-medical lay member Lay Plus 01/05/2004

Professor Atholl Johnston Professor of Clinical Pharmacology

Expert 01/05/2004

Professor Malcolm Law Epidemiologist Expert 01/04/2004

Mr John Lynch Lay Member Lay 01/10/2007

Mr Roger Maran Lay Plus 06/10/2011

Dr Eleni Palazidou Consultant Psychiatrist & Honorary Senior Lecturer

Expert 01/05/2004

Professor Kim Piper Consultant Histopathologist/Professor of Oral Pathology

Expert 01/03/2008

Dr Melanie Powell Consultant Clinical Oncologist

Expert 01/04/2004

Ms Brigid Tucker Non-Medical Lay Member Lay Plus 01/05/2004

Dr Arthur T. Tucker Principal Clinical Scientist & Honorary Reader, (REC Chairman)

Expert 01/05/2004

Professor David Wingate Gastroenterologist Expert 01/05/2004

Deputy Members


Meeting date attended

Dr Ariel Zosmer Honorary Senior Clinical Lecturer

Expert 03/05/2012, 07/06/2012, 06/09/2012, 01/11/2012, 06/12/2012, 07/02/2013, 07/03/2013


Co-opted Members



Member Bank




NRES Committee London - City & East: Members’ Declarations of Interest:

Name Declaration of Interest Date

Dr Melanie Powell Member of Local Clinical Governance Committee. NCRI Gynaecological Clinical Studies Group

05/04/2012

Dr Arthur T. Tucker Seahorse Scientific Services Ltd. Seahorse Laboratories Ltd. Edixomed Ltd. Sky Medical Technology Ltd. & First Kind Ltd. Principal Clinical Scientist, Barts Health NHS Trust. Reader, William Harvey Research Institute, QMUL. Algaecytes Ltd. Barchester Group Ltd. Cardiocity Ltd. FimpacTT AG. Gabriel Scientific Ltd. MAC Ltd. Tarilian Laser Technology Ltd. TransDermal Solutions Corporation.

29/03/2013

Professor David Wingate Member of Whitechapel Society for the Advancement of Research in Gastroenterology. Trustee of Harold Hyam Wingate Foundation

29/03/2013

Professor Malcolm Law None 29/03/2013

Ms Janelle Hill None 29/03/2013

Dr Marie E Bardsley Data Manager. Data Sharing Initiative Royal London Hospital. Whitechapel Commission on Publishing Ethics (COPE) Member of Labour Party

29/03/2013

Professor Atholl Johnston Positions - Various Pharma Companies Consultant, Director – Esprit. Other ownership/ involvement- ASI Ltd. , Seahorse Scientific Services Ltd. Queen Mary University of London

29/03/2013

Dr Ayse Baxter Principal, AB Med Ex Consulting. Clinical and Medical Regulatory Consultancy to Pharmaceutical Industry.

19/11/2012

Dr Eleni Palazidou None 03/05/2012

Mr John Lynch None 13/12/2012

Professor Kim Piper None 29/03/2013

Dr Louise Abrams None 01/12/2012

Dr Chandan Alam Director - Transdermal Delivery Solutions Corp. , Florida, US. Director, Medical - Cells United, Oslo, Norway

01/12/2012

Dr Miran Epstein None 07/03/2013

Ms Brigid Tucker None. Currently employed by a UK statutory healthcare regulator (General Osteopathic Council) and represent the regulator on the UK National Council for Osteopathic Research (NCOR). As a healthcare regulator, we periodically commission research that informs policy development. This forms part of my remit.

07/03/2013

Mr Frank Cross None 07/03/2013

Dr Melanie Powell Member of Local Clinical Governance Committee. NCRI Gynaecological Clinical Studies Group

10/01/2013

Ms Jane Batchelor Centre Administrator, Advanced Cardiovascular 07/03/2013


Imaging, William Harvey Research Institute, QMUL

Dr Ariel Zosmer None 07/02/2013

Mr Roger Maran Shares in GlaxoSmithKline 31/03/2013


Meetings for Full Ethical Review 01 April 2012 - 31 March 2013:

Proportionate Review Sub Committee Meetings held during 01 April 2012 - 31 March 2013:

Month Date Number of Members Present at Meeting

April 05/04/2012 17

May 03/05/2012 16

June 07/06/2012 13

July 05/07/2012 9

August 02/08/2012 11

September 06/09/2012 13

October 04/10/2012 14

November 01/11/2012 15

December 06/12/2012 10

January 10/01/2013 13

February 07/02/2013 12

March 07/03/2013 16

12 full committee meetings were held during the reporting period.

Month Date Number of Members Present at Meeting

April 16/04/2012 3

May 28/05/2012 3

June 25/06/2012 3

August 27/08/2012 3

September 15/09/2012 4

October 22/10/2012 3

January 22/01/2013 3

February 26/02/2013 3

March 26/03/2013 3

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


Attendance of Members: 01 April 2012 – 31 March 2013:

Name Number of Meetings Attended

Professor David Wingate 12

Mr Roger Maran 11

Ms Jane Batchelor 11

Ms Janelle Hill 11

Dr Marie E Bardsley 11

Ms Brigid Tucker 10

Mr Frank Cross 9

Mr John Lynch 9

Dr Arthur T. Tucker 9

Dr Ayse Baxter 9

Dr Eleni Palazidou 9

Dr Louise Abrams 9

Dr Miran Epstein 8

Professor Kim Piper 7

Dr Ariel Zosmer 7

Professor Malcolm Law 7

Dr Melanie Powell 7

Professor Atholl Johnston 6

Dr Chandan Alam 4

Number of inquorate meetings held: 0


Attendance of Members at proportionate review sub-committee meetings: 01 April 2012 – 31 March 2013:

Name Number of Meetings Attended

Dr Arthur Tucker 6

Mr John Lynch 3

Dr Louise Abrams 3

Professor David Wingate 3

Ms Janelle Hill 2

Mr Roger Maran 2

Dr Ayse Baxter 2

Dr Chandan Alam 2

Ms Brigid Tucker 1

Ms Jane Batchelor 1

Professor Atholl Johnston 1

Dr Miran Epstein 1

Professor Kim Piper 1

Dr Ariel Zosmer 1


Training 01 April 2012 – 31 March 2013:

Name of Member Date Event(s) attended

Dr Ayse Baxter 19/04/2012 - 19/04/2012 Research Fraud, NRES

Dr Eleni Palazidou 21/11/2012 - 21/11/2012 Adults Lacking Capacity: an advanced workshop for RECs, NRES

Mr Frank Cross 05/12/2012 - 05/12/2012 Awareness Training in Human Factors and Risk Assessment, NHS

Ms Jane Batchelor 26/04/2012 - 26/04/2012 Induction, NRES

Mr Roger Maran 26/04/2012 - 26/04/2012 Induction, NRES

Dr Arthur T. Tucker 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Dr Arthur T. Tucker 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Louise Abrams 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Dr Louise Abrams 07/02/2013 - 07/02/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Chandan Alam 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Chandan Alam 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees, NRES

Dr Miran Epstein 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees, NRES

Dr Miran Epstein 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Professor Malcolm Law 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Professor Malcolm Law 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Ms Brigid Tucker 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees, NRES


Ms Brigid Tucker 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Professor David Wingate 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Professor David Wingate 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Ayse Baxter 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Ayse Baxter 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Dr Arthur T. Tucker 20/06/2012 - 20/06/2016 Good Clinical Practice, Barts Health NHS Trust

Dr Arthur T. Tucker 05/03/2013 - 06/03/2013 Information Governance 1 & 2, Confidentiality & Caldicott, & Record Keeping Assessment 100%., NHS Information Systems

Professor Atholl Johnston 27/03/2013 – 27/03/2013 Good Clinical Practice, Barts Health NHS Trust

Mr Frank Cross 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Mr Frank Cross 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Ms Janelle Hill 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Ms Janelle Hill 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Dr Melanie Powell 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Dr Melanie Powell 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Marie E Bardsley 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research –


Claire Edgeworth from NIGB , NRES

Dr Marie E Bardsley 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Mr John Lynch 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Mr John Lynch 07/03/2013 - 07/03/2013 Training for REC Members- Personal Data in Research – Claire Edgeworth from NIGB , NRES

Mr Roger Maran 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Mr Roger Maran 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Ms Jane Batchelor 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES

Ms Jane Batchelor 07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Ariel Zosmer

07/03/2013 - 07/03/2013 Training for REC Members - Personal Data in Research – Claire Edgeworth from NIGB , NRES

Dr Ariel Zosmer 07/03/2013 - 07/03/2013 Training for REC Members on CTIMPs studies by Dr Daryl Rees , NRES


List of Training Events Organised Locally by the Co-ordinator: 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 3: Decisions given at meetings held within the reporting period:

Table 2: Other REC activity during the reporting period:

Applications for full ethical review – Study Type Number %

Clinical Trial of Investigational Medicinal Product 26 37.68

Phase 1 0 0.00

Gene Therapy 0 0.00

Research Tissue Bank 0 0.00

Research Database 0 0.00

Others 43 62.32

Total Applications Reviewed 69 100

Number of applications made invalid by co-ordinator 0

Number of studies withdrawn prior to the meeting 12

Number of student applications reviewed 15

Number of paediatric applications reviewed 8

Number of device applications reviewed 4

Number of prisoner applications reviewed 0

Number of applications involving adults unable consent reviewed 0

Number of applications reviewed funded by the US DHHS 1

Decisions taken at meetings following review of applications

Number %

Favourable Opinion with Standard Conditions 5 7.25

Favourable Opinion with Additional Conditions 26 37.68

Unfavourable Opinion 2 2.90

Provisional Opinion 31 44.93

Invalid 0 0.00

No Opinion Pending Consultation with Referee 0 0.00

Provisional Opinion Pending Consultation with Referee 5 7.25

Not Requiring Review by NHS REC 0 0.00

Total 69 100

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

25 36.23

Further Information Favourable Opinion with Additional Conditions

10 14.49

Further Information Unfavourable Opinion 0 0.00





Provisional Opinion Pending Consultation with Referee 0 0.00

Invalid 0 0.00

No Opinion Pending Consultation with Referee 0 0.00

Further Information response not complete 0 0.00

Not Requiring Review by NHS REC 0 0.00

No decision entered on RED 0 0.00

Number of studies withdrawn after the meeting 0 0.00

Total 69 100


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

Table 6: Decisions given at proportionate review sub-committee meetings held within the reporting period:

Total Applications Reviewed 28

Decisions taken at proportionate review sub-committee meetings

Number %



No Opinion transfer to full committee for review 2 7.14



Total 28 100


Table 7: Other Management Information for the reporting period:

Average number of applications reviewed per full meeting

5.75

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 days taken to final decision - average 34

Number of days taken to final decision - mode 28

Number of SSAs (non-Phase 1) reviewed 16

Number of applications for SSA review over 25 days 1

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

6.3%

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%

Number of substantial amendments reviewed 177

Number of substantial amendments over 35 days 4

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

2.2%

Number of Section 30 applications reviewed 0

Number of Section 30 applications over 60 days 0

Number of Section 30 applications over 60 days as a % of total Section 30 applications

0%

Number of modified amendments reviewed 4

Number of modified amendments over 14 days 1

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

25.0%

Number of proportionate review applications for ethical review over 14 days*

1

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

3.8%


Table 8: Breakdown of current status of all applications reviewed within the reporting period:

Further Information Favourable Opinion with Standard Conditions

REC Reference Application Short Title Number of Days on Clock

12/LO/0498 The Genetics of Congenital Vascular Anomalies 42

12/LO/0681 INR self & clinic-based tester perceptions of an anticoag. service 32

12/LO/0794 CHR258 in HCC 42

12/LO/0933 A Toolkit for Comprehensive Assessment of Anxious Children 15

12/LO/0934 Structured education for the Arabic speakers with type 2 diabetes V5 13

12/LO/0949 C16010: Phase 3 study of MLN9708 in Multiple Myeloma 39

12/LO/1022 Patient and parent experience of orthodontic treatment for CLP. 38

12/LO/1030 MRI biomarkers of low grade glioma growth and infiltration v.1.0 39

12/LO/1341 Integrated treatments for musculoskeletal disorders 33

12/LO/1356 Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients 38

12/LO/1416 WIL-20 Post Marketing Surveillance 39

12/LO/1516 Testing for tuberculosis in a UK HIV infected population 40

12/LO/1525 rTMS in Anorexia Nervosa 39

12/LO/1588 Understanding safe general practice – patients’ views 11

12/LO/1635 PEntoxifylline in Anaemia Resistant to erythropoieting (PEAR) 49

12/LO/1721 Psychiatrist-patient communication in depression and bipolar: Version 1 34

12/LO/1776 Adherence in cystic fibrosis 13

12/LO/1838 Intraluminal gut oximetry 30

12/LO/1908 Safety of BPS804 in patients with late-stage chronic kidney disease 31

12/LO/1958 Adherence in Orthodontic patients 27

12/LO/2003 A Study of the Cervix and Vaginal Flora in Preterm Delivery. Version 1 49

13/LO/0049 REPARO NGF0212 Phase I/II Neurotrophic Keratitis Trial 34

13/LO/0052 QST and fibromyalgia 31

13/LO/0121 PRAMS: Prediction of Recovery and Monitoring after Stroke 29

13/LO/0315 BAMI 40

13/LO/0348 Mycobacterium tuberculosis phenotype in sputum 13

13/LO/0508 Client Engagement with Early Intervention for Psychosis 13


Further Information Favourable Opinion with Additional Conditions


12/LO/0593 Daratumumab with lenalidomide and dexamethasone in multiple myeloma 34

12/LO/0594 Daratumumab with bortezomib and dexamethasone in multiple myeloma 34

12/LO/0649 Women with mental illness: the initial appointment with a Midwife V1 30

12/LO/0720 Phase 1/2 Dose-finding Study of MEDI-551 in Subjects with RRMS 54

12/LO/1017 Drug Drug interaction Trial between AT1001 & Agalsidase Version 4 52

12/LO/1653 NEPTUNE 28

12/LO/1717 ZEBRA 40

12/LO/1949 Withdrawal of life sustaining treatment in newborn babies 34

13/LO/0079 Efficacy Study of Rotigotine on Parkinson's Disease Associated Pain 39

13/LO/0180 Epidemiology, treatment and Outcome of Childhood Arthritis 9

Further Information Unfavourable Opinion


Favourable Opinion with Standard Conditions


12/LO/0482 Peruse: Global safety study with pertuzumab in Her2+ advanced BC 32

12/LO/0500 Lived experiences of Afro-Caribbean men with prostate cancer in London 42

12/LO/0525 Physical Activity A 'Leisure Activity' or Another Treatment 13

12/LO/0531 Assessment of hand function in peripheral neuropathy 40

12/LO/0680 Blink dynamics and dry eye 13

12/LO/0689 UKOSS: Transfusion management in major obstetric haemorrhage 13

12/LO/0838 Phase 2a Study to Test TCN-032 in Volunteers Challenged with Influenza 28

12/LO/0932 ACE-R: variables associated with outcome in adults who misuse alcohol 14

12/LO/1774 Prevalence of MSSA in emergency admission and elective patients 6

13/LO/0046 Surgical metabolic phenotype 30

13/LO/0344 The effect of adenomyosis on reproductive performance 9


13/LO/0345 (duplicate) Autobiographical accounts in diagnostic assessment for chi 13

Favourable Opinion with Additional Conditions


12/LO/0557 Perspectives of care home services: service users and support staff V1 32

12/LO/0672 ACHILLES 27

12/LO/0678 Deaf Young People Experiences of Psychiatric Inpatient Admission 12

12/LO/0685 Understanding the journey of women with breast cancer 27

12/LO/0849 Pregnomics - longitudinal omics profiling during and after pregnancy 1 28

12/LO/0854 Clinical use of a removable oral appliance adherence monitor 29

12/LO/0944 Neonatal discharge package to increase parental confidence 14

12/LO/1032 Learning Disabilty and The Recovery Approach 38

12/LO/1053 The preterm baby as a young adult - Version 1 31

12/LO/1074 Gemcitabine elaidate+cisplatin in Advanced Solid Tumours/NSCLC III/IV 28

12/LO/1105 factors which influence discontinuation of breast v1 6

12/LO/1123 Molecular and imaging biomarkers of hypoxia in head and neck cancer 21

12/LO/1138 MELCAP 21

12/LO/1139 Macushield and eye 21

12/LO/1153 Effect of Recell on donor site healing in the elderly 22

12/LO/1168 R2W: Randomised phase 2 trial in Waldenstrom macroglobulinaemia 21

12/LO/1277 Evaluating Modes of Influenza Transmission v1 20

12/LO/1312 RFN for SIJ Disease Study 36

12/LO/1313 ROX CONTROL HTN STUDY: Protocol RH-02 Version 1.0, June 20, 2012 22

12/LO/1348 Patients 'Not Seen' at Community Sexual Health Clinics 28

12/LO/1469 Experience of IQ tests by people with intellectual disability (v.1) 11

12/LO/1470 Psychological Therapies for Chronic Fatigue: An IPA (Version 4) 14

12/LO/1471 Development of outcome measures for parents of children with JIA 14

12/LO/1492 Life Study 26

12/LO/1552 Hormonal changes in Glycogen Storage Disease 28

12/LO/1559 Study evaluating the effect of GS-5806 in volunteers infected with RSV 25

12/LO/1585 Shared decision making for trust between older patients and their GPs 10

12/LO/1643 Computer-based intervention for men with STI - Qualitative field work 27


12/LO/1731 EnligHTN II 26

12/LO/2005 Pilot: Evaluation of a breast cancer awareness DVD intervention 27

13/LO/0009 HRV16 challenge study to examine JNJ-43260295 in healthy subjects 31

13/LO/0033 GO28509 PEGGY - Phase 2 study of GDC-0941 in metastatic breast cancer 31

13/LO/0117 TBI: the transition from in-patient rehabilitation to the community 26

13/LO/0504 Detection of Coagulopathy in Paediatric Heart Surgery 13

13/LO/0505 Therapist Effects with IAPT Low Intensity Practitioners v.1 9

13/LO/0507 EEG MONTAGES (VERSION 1) 9

Unfavourable Opinion


12/LO/0878 What Do We Mean By Madness; How and When is it Used Today? 29

12/LO/1626 Adherence in Orthodontic patients 57

Provisional Opinion


12/LO/0677 Phase 2a trial of MDT-637 in healthy subject challenged with RSV. N/A

13/LO/0167 The delivery of compassionate care : the role of the middle manager v1 N/A

Provisional Opinion Pending Consultation with Referee


Further information response not complete


Withdrawn after the meeting



Invalid Application


No Opinion Pending Consultation with Referee


Not Requiring Review by NHS REC



Table 9: Items exceeding timelines:

Full applications for ethical review over 60 day timeline


Proportionate review applications for ethical review over 14 days timeline


12/LO/0933 A Toolkit for Comprehensive Assessment of Anxious Children 15

SSAs (non Phase 1) over 25 days timeline


12/LO/0642 Preloading Trial 32

SSAs (Phase 1) over 14 days timeline


Substantial Amendments over 35 day timeline

Amendment Reference Application Short Title Amendment Title Number of Days on Clock

10/H0704/81/AM02 Left ventricular and vascular remodelling in chronic kidney disease

AM02 Substantial Amendment Dated 01 June 2012

36

12/LO/0720/AM06 Phase 1/2 Dose-finding Study of MEDI-551 in Subjects with RRMS

Substantial Amendment 5, CENSUM Website document

45

12/LO/1559/AM02 Study evaluating the effect of GS-5806 in volunteers infected with RSV

AM02 Substantial Amendment 02 Dated 28.01.2013

37

12/LO/0593/AM03 Daratumumab with lenalidomide and dexamethasone in multiple myeloma

AM03 Substantial Amendment 3, Protocol Amendment 4

40


Modified Amendments over 14 day timeline


10/H0704/81/AM02/1 Left ventricular and vascular remodelling in chronic kidney disease

Modified Amendment 1 to SA 2 dated 1st June 2012

22

Section 30 application over 60 day timeline


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