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NRES Committee London - Dulwich
Annual Report
01 April 2012 – 31 March 2013
National Research Ethics
Service
NRES Committee London - Dulwich Annual Report Page 2
Part 1 – Committee Membership and Training
Chair’s overview of the past year:
Name of REC: NRES Committee London - Dulwich Type of REC: Type 3 Type of Flag: Medical Devices
Research Involving Children Chair: Dr Michael Philpot
Vice-Chair: Mr Colin Standfield
Alternate Vice-Chair: n/a
Co-ordinator: Ms Stephanie Hill PRSC Co-ordinator: None Assistant Co-ordinator: Mr Claude Beckles Committee Address: Health Research Authority
Skipton House 80 London Road London SE1 6LH
Telephone: 020 7972 2582 Email: nrescommittee.london-dulwich@nhs.net
The past year has seen a period of relative stability with regard to personnel on the REC. This has enabled us to consolidate our skills and expertise. We thank Dr Patrick Gordon, who resigned in August 2012, for his excellent five year contribution. Recruitment is still an issue for us and we have had to co-opt members from other RECs more often than in the past. One meeting (March 2013) became inquorate for the last two applications but was re-convened as a telephone conference the following day. Our Coordinator, Stephanie Hill, and Assistant Coordinator, Claude Beckles, have worked hard to make progress towards ensuring that time-lines are met and other aspects of the REC’s work are within accepted standards. There has been a further reduction in studies reviewed by the full REC on the previous year. 20% are medical devices studies, for which we are flagged, and perhaps the recent concern about regulation in this industry has prompted us to take more time over these in the past year. 95% of all studies receive a favourable or provisional opinion. Unfortunately the time taken to deal with new applications and amendments exceeds the accepted limits in about half of cases. There is an action plan in place to manage this problem.
NRES Committee London - Dulwich Annual Report Page 3
NRES Committee London - Dulwich Membership:
Name Occupation Expert or Lay
Dates
Appointed Resigned
Dr Will Bernal Consultant Liver Intensivist
Expert 31/03/2006
Mr Kai Loke Chan Assistant Director of Pharmacy
Expert 20/02/2005
Ms Madeleine Colvin Barrister Lay Plus 17/09/2007
Mr John Fowler Lay Member Lay 31/05/2005
Dr Patrick Gordon Consultant Rheumatologist
Expert 01/09/2007 16/08/2012
Mrs Carole Jordan Senior Nurse Expert 01/04/2010
Dr Thomas Kabir MHRN Service Users in Research Coordinator
Lay 10/02/2010
Mr Enock Khoromana Clinical Research Associate
Lay 01/10/2010
Dr Michael Philpot Consultant Psychiatrist Expert 30/12/2007
Ms Anna Ramberg Research Development Manager
Lay Plus 01/10/2010
Mr Krzysztof Rutkowski Research Nurse Expert 01/08/2010
Mr Colin Standfield Charity Worker Lay 01/02/2012
Ms Catherine Walton Consultant Midwife Expert 30/06/2006
Co-opted Members
Name Occupation Expert or Lay
Meeting date attended
Ms Rhona Bratt Lay Member Lay 15/08/2012
Ms Stephanie Ellis Lay Member Lay 18/07/2012 15/08/2012
Ms Karen Sanders Senior Lecturer Expert 19/09/2012
NRES Committee London - Dulwich Annual Report Page 4
NRES Committee London - Dulwich: Members’ Declarations of Interest:
Name Declaration of Interest Date
Ms Madeleine Colvin Member of ESBAC - Department of Health's new Advisory Committee on Emerging Sciences and Bioethics.
20/09/2012
Ms Madeleine Colvin Member of Confidentiality Advisory Group (CAG) Health Research Authority
31/03/2013
Mr Colin Standfield Wife has a small number of shares in a portfolio including Astra Zeneca. Trustee of Drug Scope. Wife is Assistant Service Manager, Women's and Children's Health at Ealing Hospital; she has no research involvement.
31/03/2013
John Fowler Employed by a charity, the Local Government Information Unit, which given the return of public health to local government may be involved in health and social care research. Wife (Dr B Cooper) employed by GSTT and has the potential to do research.
31/03/2013
Ms Catherine Walton None. 31/03/2013
Ms Anna Ramberg Research Development Manager, City University London. My position at City involves the overview of research ethics activity across the institution, including Secretary to the Senate REC.
31/03/2013
Dr Michael Philpot Member of the Alzheimer's Society Member of Alzheimer's Disease International
31/03/2013
Mr Kai Lok Chan Member of departmental research and audit group, Pharmacy, King’s College Hospital
31/03/2013
Mrs Carole Jordan None. 31/03/2013
Dr Thomas Kabir Employed by the Mental Health Research Network at the Institute of Psychiatry.Co-applicant on two NIHR funding applications.
31/03/2013
Mr Krzysztof Rutkowski Works as a Research Nurse. 31/03/2013
NRES Committee London - Dulwich Annual Report Page 5
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 18/04/2012 10
May 16/05/2012 9
June 20/06/2012 9
July 18/07/2012 9
August 15/08/2012 8
September 19/09/2012 8
October 17/10/2012 11
November 21/11/2012 9
January 16/01/2013 10
February 13/02/2013 7
March 13/03/2013 8
March 14/03/2013 7
12 full committee meetings were held during the reporting period (The meeting held on 13 March became inquorate during the meeting and as a result the remaining members were unable to give an opinion to the applications yet to be reviewed. The meeting was reconvened the following day to give an opinion on these applications).
Month Date Number of Members Present at Meeting
May 23/05/2012 3
June 06/06/2012 3
July 04/07/2012 3
August 01/08/2012 3
4 proportionate review sub-committee meetings were held during the reporting period.
NRES Committee London - Dulwich Annual Report Page 6
Attendance of Members: 01 April 2012 – 31 March 2013:
Attendance of Members at proportionate review sub-committee meetings: 01 April 2012 – 31 March 2013:
Name Number of Meetings Attended
Dr Michael Philpot 11
Mr Colin Standfield 11
Mrs Carole Jordan 10
Ms Catherine Walton 10
Ms Anna Ramberg 9
Dr Thomas Kabir 9
Dr Will Bernal 8
John Fowler 8
Mr Kai Loke Chan 8
Mr Krzysztof Rutkowski 7
Ms Madeleine Colvin 6
Mr Enock Khoromana 2
Stephanie Ellis 2
Dr Patrick Gordon 2
Ms Rhona Bratt 1
Ms Karen Sanders 1
Number of inquorate meetings held: 1 meeting became inquorate but this was reconvened
as a teleconference the following day to ensure that decisions could be given in line with SOPs
Name Number of Meetings Attended
Dr Michael Philpot 4
Mr John Fowler 3
Mr Colin Standfield 3
Mr Enock Khoromana 1
Canon Christopher Vallins 1
NRES Committee London - Dulwich Annual Report Page 7
Training 01 April 2012 – 31 March 2013:
Name of Member Date Event(s) attended
Dr Michael Philpot 18/10/2012 - 18/12/2012 Quantitative Research Design and Statistics for REC Members, NRES
Ms Madeleine Colvin 24/09/2012 - 24/09/2012 Attending Ethical Group for the National DNA Database , SDL - 4 hours every 3 months
Ms Madeleine Colvin 17/07/2012 - 17/07/2012 Attending first meeting of ESBAC (Emerging Science and Bioethics Advisory Committee) DH, SDL - 5 hours
Dr Thomas Kabir 25/02/2013 - 25/02/2013 NIHR Good Clinical Practice Course, SDL
Dr Thomas Kabir 12/12/2012 - 12/12/2012 Psychiatric Ethics Training Course, SDL
Dr Michael Philpot 03/10/2012 - 03/10/2012 Fair numbers - what does ethical, quantitative research design look like?, HTA
Dr Michael Philpot 06/03/2013 - 06/03/2013 HRA REC Chair's event, HTA
Dr Michael Philpot 29/05/2012 - 29/05/2012 "Why the exclusion of older people from clinical research must stop", SDL - Private Reading, BMJ - 0.5 hrs
Dr Michael Philpot 29/05/2012 - 29/05/2012 "Rethinking medical device regulation", SDL - Private Reading, JRSM - 0.5 hrs
Dr Michael Philpot 30/08/2012 - 30/08/2012 "Tackling research misconduct", SDL - Private reading, BMJ - 0.5 hrs
Dr Michael Philpot 01/10/2012 - 01/10/2012 Chapter 14 on research in Medical Ethics Today, SDL - Private reading, 1.5 hrs
Dr Michael Philpot 01/10/2012 - 01/10/2012 Sample size calculations, SDL - Private reading, BMJ 15 Sept 2012 - 1 hr
Dr Michael Philpot 01/01/2013 - 01/01/2013 NRES guidance on Medical Devices, SDL - Private reading - 2 hrs
Dr Michael Philpot 01/04/2012 - 30/11/2012 Active participation in research, SDL - Approximately 10 hrs
NRES Committee London - Dulwich Annual Report Page 8
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 4 6.56
Phase 1 0 0.00
Gene Therapy 0 0.00
Research Tissue Bank 0 0.00
Research Database 0 0.00
Others 57 93.44
Total Applications Reviewed 61 100
Number of applications made invalid by co-ordinator 4
Number of studies withdrawn prior to the meeting 8
Number of student applications reviewed 14
Number of paediatric applications reviewed 8
Number of device applications reviewed 13
Number of prisoner applications reviewed 0
Number of applications involving adults unable consent reviewed 0
Number of applications reviewed funded by the US DHHS 0
Decisions taken at meetings following review of applications
Number %
Favourable Opinion with Standard Conditions 0 0.00
Favourable Opinion with Additional Conditions 12 19.67
Unfavourable Opinion 3 4.92
Provisional Opinion 46 75.41
Invalid 0 0.00
No Opinion Pending Consultation with Referee 0 0.00
Provisional Opinion Pending Consultation with Referee 0 0.00
Not Requiring Review by NHS REC 0 0.00
Total 61 100
Number of studies sent back to full committee meeting for final opinion
1
NRES Committee London - Dulwich Annual Report Page 9
Table 4: Summary of current status of applications reviewed during the reporting period:
Status of applications at date of generation of report
Number %
Further Information Favourable Opinion with Standard Conditions
43 70.49
Further Information Favourable Opinion with Additional Conditions
2 3.28
Further Information Unfavourable Opinion 0 0.00
Favourable Opinion with Standard Conditions 0 0.00
Favourable Opinion with Additional Conditions 12 19.67
Unfavourable Opinion 3 4.92
Provisional Opinion 1 1.64
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 61 100
NRES Committee London - Dulwich Annual Report Page 10
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 8
Decisions taken at proportionate review sub-committee meetings
Number %
Favourable Opinion with Standard Conditions 4 50.00
Favourable Opinion with Additional Conditions 3 37.50
No Opinion transfer to full committee for review 1 12.50
Provisional Opinion 0 0.00
Unfavourable Opinion 0 0.00
Total 8 100
NRES Committee London - Dulwich Annual Report Page 11
Table 7: Other Management Information for the reporting period:
Average number of applications reviewed per full meeting
5.08
Number of applications for full ethical review over 60 days
27
Number of applications over 60 days as a % of total 44.26%
Number of days taken to final decision - average 60
Number of days taken to final decision - mode 46
Number of SSAs (non-Phase 1) reviewed 1
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)
100.0%
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 91
Number of substantial amendments over 35 days 47
Number of substantial amendments over 35 days as a % of total substantial amendments
51.6%
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 2
Number of modified amendments over 14 days 1
Number of modified amendments over 14 days as a % of total modified amendments
50.0%
Number of proportionate review applications for ethical review over 14 days
7
Number of proportionate review applications over 14 days as a % of total
100.00%
NRES Committee London - Dulwich Annual Report Page 12
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/0460 EURO-CTO 129
12/LO/0462 Normothermic liver preservation - a pilot study 97
12/LO/0587 Identifying prevalence of lymphoedema in attendees of "at risk" class 97
12/LO/0591 Plasma citrulline as an indicator for acidosis in short bowel syndrome 32
12/LO/0725 How do young adults living with cancer experience supportive care? 133
12/LO/0731 Multi-Family Therapy for Bulimia Nervosa - version 1 66
12/LO/0763 Edwards PROTAVI-C Study #2012-01 45
12/LO/0917 MOVE-IT (Motivational Enhanced Interviewing) 85
12/LO/0980 PROCEED Trial in Participants with Ovarian Cancer 77
12/LO/0990 EMTICS 96
12/LO/1007 Study of the use of a digital system in patients with pneumothorax 1 100
12/LO/1047 JV-03-PMS - The Jupiter Registry 92
12/LO/1066 Nitrite and Coronary Flow V1 58
12/LO/1103 Portico TA EU 73
12/LO/1125 Occlutech percutaneous PFO closure: Safety and Efficacy OPPOSE Registry 76
12/LO/1131 STERILE 40
12/LO/1192 Validation Study on ASSPT to diagnose auto-reactivety in CU 93
12/LO/1256 PliCath HFTM ECVR System, CIP-0015 Rev. D 102
12/LO/1306 Assessing Subtle Cognitive Impairment in Multiple Sclerosis 73
12/LO/1315 To investigate whether biliary atresia has an infectious aetiology 68
12/LO/1428 Transcutaneous Electrical Stimulation in Sleep Apnoea Patients 72
12/LO/1473 Cardiovascular function in hypertension 67
12/LO/1507 Attain Performa Quadripolar Lead Clinical Study V2 78
12/LO/1511 Efficacy of post partum haemorrhage (PPH) compression belt (Version 1) 87
12/LO/1545 CoreValve ADVANCE DA Study 89
12/LO/1575 Effects of feedback and volition on the attainment of head velocities 89
12/LO/1581 RCT of Particles used in Uterine fibRoid Embolization (PURE) 107
12/LO/1630 Comparing laboratory blood glucose results with HemoCue Glucose 201 RT 85
NRES Committee London - Dulwich Annual Report Page 13
12/LO/1640 CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) 37
12/LO/1762 i-Spot Study 40
12/LO/1798 Edwards SAPIEN 3 57
12/LO/1877 Role of IL-13 and TGF beta in Conjunctival Scarring 66
12/LO/2013 Exploring perfectionism in Anorexia Nervosa 52
12/LO/2015 Cognitive and emotional characteristics in anorexia nervosa 52
12/LO/2017 Brain Imaging in Babies (BIBS) 46
12/LO/2034 Anti-psychotic Medication Side Effects PROM V1 46
13/LO/0029 Medtronic Over Night Closed Loop UK study 64
13/LO/0145 CLEOPATRA 46
13/LO/0152 Transplantation of ex-vivo cultivated epithelial cells onto the eye 51
13/LO/0295 Diminished anaesthetic hypotension by the geko device 50
13/LO/0302 Assessing Eating Disorders across Ethnicity. Version 1 49
13/LO/0304 Signal Transfer of Atrial Fibrillation Data to Guide Human Treatment 34
13/LO/0320 NEAT - Nanoknife Electroporation Ablation Trial (Version 2.3) 23
Further Information Favourable Opinion with Additional Conditions
REC Reference Application Short Title Number of Days on Clock
12/LO/0588 MF/F Safety Study in Adolescent and Adult Persistent Asthmatics 46
12/LO/0887 Cortical inhibitory systems in Motor Neurone Diseases. 77
Further Information Unfavourable Opinion
REC Reference Application Short Title Number of Days on Clock
Favourable Opinion with Standard Conditions
REC Reference Application Short Title Number of Days on Clock
12/LO/1149 Time-Series Analysis into Liverpool CHD rates pre and post Smoking ban 26
12/LO/1323 Evaluation of the UCH Macmillan Cancer Centre Programme 42
12/LO/1324 LC-MS/MS Studies of Free Radicals in Endogenous & Exogenous Metabolism 19
12/LO/1327 Expression of molecular targets in colorectal cancer v1 48
NRES Committee London - Dulwich Annual Report Page 14
Favourable Opinion with Additional Conditions
REC Reference Application Short Title Number of Days on Clock
12/LO/0589 Bilateral PTNS Study 35
12/LO/0722 How we interpret unusual experiences and link to life events V.1 26
12/LO/0965 MUK six 35
12/LO/0993 CWPS validation of digital pathology. 21
12/LO/1071 Microvesicles and Plaque Rupture V1 23
12/LO/1154 Patient Perceptions of Acute Oncology - version 1 47
12/LO/1155 Sensory sensitivity in children with Autistic Spectrum Disorders 26
12/LO/1207 POKACID 51
12/LO/1368 Fatigue and Inflammation 37
12/LO/1856 Inflammatory Bowel Disease and Fatigue 42
13/LO/0013 Rekon+, a new needle-free solution for IV catheter port deliveries 33
13/LO/0151 Support for parents of children with Disorders of Sex Development V.01 42
13/LO/0155 Augmenting venous outflow with proximal thigh compression 45
13/LO/0309 Integrated psychological & weight management treatment for children 34
13/LO/0312 Caregiving experiences in accident and emergency departments 40
Unfavourable Opinion
REC Reference Application Short Title Number of Days on Clock
12/LO/0997 Cardiovascular function in hypertension 23
12/LO/1187 D&E outcomes between 15 and 24 weeks gestation 25
13/LO/0142 Uventa (NiTi-S) Ureteric Stent Trial 26
Provisional Opinion
REC Reference Application Short Title Number of Days on Clock
12/LO/1210 LIFT Study N/A
Provisional Opinion Pending Consultation with Referee
NRES Committee London - Dulwich Annual Report Page 15
REC Reference Application Short Title Number of Days on Clock
Further information response not complete
REC Reference Application Short Title Number of Days on Clock
Withdrawn after the meeting
REC Reference Application Short Title Number of Days on Clock
Invalid Application
REC Reference Application Short Title Number of Days on Clock
No Opinion Pending Consultation with Referee
REC Reference Application Short Title Number of Days on Clock
Not Requiring Review by NHS REC
REC Reference Application Short Title Number of Days on Clock
NRES Committee London - Dulwich Annual Report Page 16
Table 9: Items exceeding timelines:
Full applications for ethical review over 60 day timeline
REC Reference Application Short Title Number of Days on Clock
12/LO/0460 EURO-CTO 129
12/LO/0587 Identifying prevalence of lymphoedema in attendees of "at risk" class 97
12/LO/0462 Normothermic liver preservation - a pilot study 97
12/LO/0725 How do young adults living with cancer experience supportive care? 133
12/LO/0731 Multi-Family Therapy for Bulimia Nervosa - version 1 66
12/LO/0887 Cortical inhibitory systems in Motor Neurone Diseases. 77
12/LO/0917 MOVE-IT (Motivational Enhanced Interviewing) 85
12/LO/0980 PROCEED Trial in Participants with Ovarian Cancer 77
12/LO/1047 JV-03-PMS - The Jupiter Registry 92
12/LO/0990 EMTICS 96
12/LO/1007 Study of the use of a digital system in patients with pneumothorax 1 100
12/LO/1103 Portico TA EU 73
12/LO/1125 Occlutech percutaneous PFO closure:Safety and Efficacy OPPOSE Registry 76
12/LO/1192 Validation Study on ASSPT to diagnose auto-reactivety in CU 93
12/LO/1256 PliCath HFTM ECVR System, CIP-0015 Rev. D 102
12/LO/1306 Assessing Subtle Cognitive Impairment in Multiple Sclerosis 73
12/LO/1315 To investigate whether biliary atresia has an infectious aetiology 68
12/LO/1428 Transcutaneous Electrical Stimulation in Sleep Apnoea Patients 72
12/LO/1473 Cardiovascular function in hypertension 67
12/LO/1507 Attain Performa Quadripolar Lead Clinical Study V2 78
12/LO/1511 Efficacy of post partum haemorrhage (PPH) compression belt (Version 1) 87
12/LO/1545 CoreValve ADVANCE DA Study 89
12/LO/1575 Effects of feedback and volition on the attainment of head velocities 89
12/LO/1581 RCT of Particles used in Uterine fibRoid Embolization (PURE) 107
12/LO/1630 Comparing laboratory blood glucose results with HemoCue Glucose 201 RT 85
12/LO/1877 Role of IL-13 and TGF beta in Conjunctival Scarring 66
NRES Committee London - Dulwich Annual Report Page 17
13/LO/0029 Medtronic Over Night Closed Loop UK study 64
Proportionate review applications for ethical review over 14 days timeline
REC Reference Application Short Title Number of Days on Clock
12/LO/0993 CWPS validation of digital pathology. 21
12/LO/1149 Time-Series Analysis into Liverpool CHD rates pre and post Smoking ban 26
12/LO/1154 Patient Perceptions of Acute Oncology - version 1 47
12/LO/1155 Sensory sensitivity in children with Autistic Spectrum Disorders 26
12/LO/1323 Evaluation of the UCH Macmillan Cancer Centre Programme 42
12/LO/1324 LC-MS/MS Studies of Free Radicals in Endogenous & Exogenous Metabolism 19
12/LO/1327 Expression of molecular targets in colorectal cancer v1 48
SSAs (non Phase 1) over 25 days timeline
REC Reference Application Short Title Number of Days on Clock
13/LO/0144 Intracardiac potassium chloride before dilatation and evacuation 38
SSAs (Phase 1) over 14 days timeline
REC Reference Application Short Title Number of Days on Clock
Substantial Amendments over 35 day timeline
Amendment Reference Application Short Title Amendment Title Number of Days on Clock
10/H0808/27/AM03 Zenith TX2 Low-Profile Clinical Study #08-017-02
AM03 - Clinical Investigation Plan 45
12/LO/0056/AM01 IRIS, 11-001 11-001, version E, 19th March 2012
88
11/LO/0110/AM02 Solvay 3005 - Open Label Study in Subjects with Advanced PD
Amendment dated 13 March 2012 79
08/H0808/1/AM03 The T2 SOUL study, version 1 Amendment dated 20 March 2012 56
09/H0808/82/AM10 13vPnC paediatric sickle cell study Protocol Amendment 3 63
NRES Committee London - Dulwich Annual Report Page 18
11/LO/1697/AM01 Improving engagement in early interventions in psychosis
Amendment dated 21/03/2012 69
10/H0808/139/AM03 FAME II - 0904 - April 6, 2010 03, 21-Mar-2012 42
11/LO/1043/AM02 RETILASE TRIAL 01, 02 April 2012 43
11/LO/0397/AM01 Parental attitudes to minimally invasive autopsy
Amendment dated 17/4/2012 43
11/LO/0743/AM01 PARACHUTE III Amendment 1 13 April 2012 57
11/LO/2017/AM01 The Evaluation of the Firesetting Intervention Programme
Amendment number 1 02/05/12 47
10/H0808/62/AM04 Comparison of GnRH analogue and tourniquet on blood loss in myomectomy
Substantial Amendment 4 39
10/H0808/30/AM03 Inflammatory Biomarkers of IFN-alpha-Induced Psychiatric Symptoms (1)
Amendment Number 09/05/2012 37
11/LO/1253/AM02 A survey study on surgical complications and patient wellbeing
Amendment 2.0, 29/05/2012 40
09/H0808/15/AM01 Non-invasive biomarkers and paediatric NAFLD v1.0
Sub Am 1, 23 Feb 2010 801
12/LO/0236/AM01 A process evaluation of EPT to treat cancer survivors with PTSD
Substantial Amendment 1 51
10/H0808/111/AM02 Prevalence of medication use in early pregnancy
Substantial Amendment 2 9th July 2012
50
11/LO/0784/AM02 COSIRA - REDCLN-006 Rev.A Substantial Amendment 45
08/H0808/188/AM02 Imaging and electro-physiology in patients undergoing neuromodulation
Substantial Amendment 3 28th June 2012
50
12/LO/0044/AM02 The IARE Study Substantial Amendment 1, 13th July 2012
46
10/H0808/135/AM04 Psychological risk factors for fatigue in Rheumatoid Arthritis
10/H0808/135/AM07 222
10/H0808/109/AM03 EXCEL Clinical Trial 1.0 18th June 2010
Substantial Amendment 16th July 2012
62
11/LO/1596/AM01 A RCT of PCI versus no PCI prior to Amendments: protocol 2.8, PIS 37
NRES Committee London - Dulwich Annual Report Page 19
TAVI 1.3, consent form 1.
07/H0808/115/AM10 Evaluation of Genetic, Psychometric and Brain responses in Dental Pain
Amendment 6 42
11/LO/0593/AM01 Exploratory study of a binocular therapy for anisometropic amblyopia
Amendment 1.0 11/07/2012 88
12/LO/0731/AM01 Multi-Family Therapy for Bulimia Nervosa - version 1
Version 2 dated 26/07/2012 139
12/LO/0763/AM01 Edwards PROTAVI-C Study #2012-01
Amendment to the protocol 69
04/Q0703/148/AM02 CC-5013 in MDS with 5q- cytogenetic abnormality
KCH-MDS-04-1.7, 09 Jul 2012 Substantial Amendment
113
11/LO/1253/AM03 A survey study on surgical complications and patient wellbeing
AM03 update to patient follow-up letter
50
11/LO/1408/AM02 ABSORB II RCT: 10-393 Change to protocol V 1 36
10/H0808/27/AM04 Zenith TX2 Low-Profile Clinical Study #08-017-02
Changes to ICF 57
10/H0808/135/AM07 Psychological risk factors for fatigue in Rheumatoid Arthritis
8 18/09/2012 73
12/LO/0588/AM01 MF/F Safety Study in Adolescent and Adult Persistent Asthmatics
Sponsor Company name change, 01/05/2012
44
12/LO/0371/AM01 The Evaluation of OCT(Optical Coherence Tomography)
Amendment dated 08 October 2012
56
09/H0808/82/AM12 13vPnC paediatric sickle cell study Investigator's Brochure, June 2012
64
12/LO/0588/AM03 MF/F Safety Study in Adolescent and Adult Persistent Asthmatics
Amendment dated 12 October 2012
80
10/H0808/124/AM02 Pervasive Biological Profiling for Sports Monitoring
Amendment to the protocol 78
12/LO/0269/AM01 IPET version 1.0 27.01.2012 Amendment to the protocol and PIS
36
12/LO/0062/AM07 Ranolazine for Incomplete Vessel Revascularization post-PCI
Amendment 3, 15 February 2012 48
10/H0808/137/AM04 The Gore REDUCE Clinical Study AM04: Protocol amendment 37
03/04/070/AM01 Molecular and biochemical markers Am01: Change to Protocol 101
NRES Committee London - Dulwich Annual Report Page 20
of pregnancy complications
12/LO/0588/AM04 MF/F Safety Study in Adolescent and Adult Persistent Asthmatics
Substantial amendment 3: Update to ICF
41
08/H0808/8/AM02 Barrett's oesophagus optical biopsy with ESS study (BOOST)
AM02: Extension to study protocol 85
10/H0808/109/AM04 EXCEL Clinical Trial 1.0 18th June 2010
Temporary Halt 62
07/Q0703/48/AM06 The effect of maternal CRH in pregnancy, on fetal HPA axis - version 1
Amendment no 4.0 dated 30-06-12
191
05/Q0703/82/AM10 Diaphragm EMG activity & breathlessness in cardiopulmonary disease
Amendment dated 10 December 2012
78
10/H0808/135/AM08 Psychological risk factors for fatigue in Rheumatoid Arthritis
Additional Cohort 37
Modified Amendments over 14 day timeline
Amendment Reference Application Short Title Amendment Title Number of Days on Clock
11/LO/1776/AM01/1 Urinary Proteomics for HIGH Risk pregnancies (UP HIGH R)
Modified Amendment dated 1/5/12
34
Section 30 application over 60 day timeline
Amendment Reference Application Short Title Amendment Title Number of Days on Clock
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