nres committee london - dulwich annual report · 2020. 11. 27. · lay 10/02/2010 mr enock...

NRES Committee London - Dulwich

Annual Report

01 April 2012 – 31 March 2013

National Research Ethics

Service

NRES Committee London - Dulwich Annual Report

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: [email protected]

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 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: 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


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.


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


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


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


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





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


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 %



No Opinion transfer to full committee for review 1 12.50



Total 8 100


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%


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


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


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


Favourable Opinion with Standard Conditions


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


Favourable Opinion with Additional Conditions


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



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


12/LO/1210 LIFT Study 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


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/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


13/LO/0029 Medtronic Over Night Closed Loop UK study 64

Proportionate review applications for ethical review over 14 days timeline


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


13/LO/0144 Intracardiac potassium chloride before dilatation and evacuation 38

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/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


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


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


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


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


of pregnancy complications


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


Additional Cohort 37

Modified Amendments over 14 day timeline


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


nres committee london - dulwich annual report · 2020. 11. 27. · lay 10/02/2010 mr enock...

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