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Research Ethics Service
RES Committee London - City & East
Annual Report
01 April 2014 - 31 March 2015
RES Committee London - City & East Annual Report Page 2
Part 1 – Committee Membership and Training
Name of REC: RES Committee London - City & East
Type of REC: REC recognised to review CTIMPs in patients - type iii
Type of Flag: IRB registered /Phase I in patients/Paediatric
Chair: Dr John Keen
Vice-Chair: Ms Alison Eden
Alternate Vice-Chair: Dr Ayse Baxter
REC Manager: Mr Rajat Khullar
REC Assistant: Mr Wai Yeung
Committee Address: Bristol Research Ethics Committee Centre Whitefriars Level 3, Block B Lewins Mead Bristol BS1 2NT
Telephone: 01173421386
Email: [email protected]
RES Committee London - City & East Annual Report Page 3
Chair’s overview of the past year:
City & East London REC underwent some modernisation in 2014-15, with changes in personnel and a new Chair and Vice-Chair, and process changes at meetings to facilitate the full participation of all members. The Committee is democratic and efficient and there is camaraderie amongst committee members. Feedback already received from researchers has been positive. Our inaugural self-organised ethics training day was a great success. The committee continues to benefit from excellent managerial support from Raj and Wai. Well done and thank you to everyone who has participated and supported me in this notable year.
Dr John W Keen Chair, London - City & East REC
RES Committee London - City & East Annual Report Page 4
RES Committee London - City & East Membership
Name Profession Expert or
Lay
Dates
Appointed Left
Dr Louise Abrams Pharmacology (Vice Chair)
Expert 01/09/2004 21/12/2014
Dr Chandan Alam Experimental Pathology Expert 01/06/2005
Dr Marie E Bardsley Director Lay 01/10/2009
Ms Clare Barron Solicitor – in-house legal department
Lay Plus 27/02/2014
Ms Jane Batchelor Centre Administrator, Advanced Cardiovascular Imaging
Lay Plus 01/12/2011
Mr James Batchelor Director of Clinical Informatics Research Unit
Lay 01/07/2014
Dr Ayse Baxter Pharmaceutical Physician Expert 01/07/2007
Dr Luis Beltran Consultant Histopathologist
Expert 01/05/2014
Mr Frank Cross Consultant General and Vascular Surgeon
Expert 13/11/2008
Ms Alison Eden Manager Patient Recruitment
Lay Plus 07/01/2015
Dr Miran Epstein Senior Lecturer Medical Ethics
Expert 01/05/2004 01/05/2014
Ms Janelle Hill Non-medical lay member Lay Plus 01/08/2004 31/07/2014
Mrs Lisa Johnson CRO Lay Plus 01/05/2014
Professor Atholl Johnston Professor of Clinical Pharmacology
Expert 01/05/2004 31/12/2014
Dr John Keen GP Expert 01/11/2014
Professor Malcolm Law Epidemiologist Expert 01/04/2004 30/11/2014
Mr John Lynch Lay Member Lay 01/10/2007
Mr Roger Maran Barrister Lay Plus 06/10/2011
Dr Dylan Morrissey Senior Clinical Lecturer in Sports and Exercise Medicine
Expert 01/05/2014
Dr Eleni Palazidou Consultant Psychiatrist & Honorary Senior Lecturer
Expert 01/01/2005
Professor Kim Piper Consultant Histopathologist/Professor of Oral Pathology
Expert 01/03/2008
Mr Roy Sinclair Pharmacist Lay 01/11/2014
Ms Brigid Tucker Head of Policy & Communications, General Osteopathic Council
Lay Plus 01/08/2004
Professor Arthur T. Tucker Lead Clinical Scientist & Reader, (REC Chair)
Expert 01/07/2004 31/10/2014
Professor David Wingate Gastroenterologist Expert 01/05/2004 01/05/2014
Dr Ariel Zosmer Honorary Senior Clinical Lecturer
Expert 01/06/2014
RES Committee London - City & East Annual Report Page 5
RES Committee London - City & East: Deputy Members
RES Committee London - City & East: Co-opted Members
Name Profession Status Meeting date attended
Ms Clare Barron Solicitor – in-house legal department
Lay Plus 01/05/2014, 05/06/2014, 04/09/2014, 02/10/2014,
06/11/2014
Mr James Batchelor Director of Clinical Informatics Research Unit
Lay 04/09/2014, 04/12/2014
Dr Luis Beltran Consultant Histopathologist
Expert 04/12/2014, 06/11/2014, 04/09/2014, 03/07/2014, 01/05/2014, 05/06/2014
Ms Lisa Johnson Project management of Phase 1 and 2 clinical trials
Lay Plus 02/10/2014, 06/11/2014, 04/12/2014, 03/07/2014, 04/09/2014, 08/01/2015, 01/05/2014, 05/06/2014
Mr D Morrissey Senior Clinical Lecturer in Sports and Exercise Medicine
None 05/06/2014, 08/01/2015, 03/07/2014, 05/02/2015, 06/11/2014, 02/10/2014
Dr Ariel Zosmer Honorary Senior Clinical Lecturer
Expert 03/04/2014,
Name Profession Status Meeting date attended
RES Committee London - City & East Annual Report Page 6
RES Committee London - City & East: Members’ Declarations of Interest:
Name Declaration of Interest Date
Dr Louise Abrams None 06/11/2014
Dr Chandan Alam Director - Transdermal Delivery Solutions Corp. , Florida, US Director, Medical - Cells United, Oslo, Norway
04/12/2014
Dr Marie E Bardsley Data Manager Data Sharing Initiative Royal London Hospital Whitechapel Commission on Publishing Ethics (COPE) Member of Labour Party
10/04/2014
Ms Clare Barron None 28/04/2014
Mr James Batchelor None 24/07/2014
Ms Jane Batchelor Centre Administrator, Advanced Cardiovascular Imaging, William Harvey Research Institute, QMUL
04/12/2014
Dr Ayse Baxter Shares in AstraZeneca Shares in Glaxo Smithkline 31/03/2015
Dr Luis Beltran No declarations of interest 01/05/2014
Mr Frank Cross No declarations of interest 05/02/2015
Mrs Lisa Johnson Regional Study Manager – Allergan Shares in AstraZeneca
17/06/2014
Dr John Keen Member of NREAP (HRA Advisory Panel) 07/11/2014
Mr John Lynch None 04/12/2014
Mr Roger Maran Shares in GlaxoSmithKline as part of a professionally managed share portfolio
04/12/2014
Dr Dylan Morrissey No declarations of interest 01/10/2014
Mr Roy Sinclair No declarations of interest 01/11/2014
Ms Brigid Tucker 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.
04/09/2014
Dr Ariel Zosmer None 11/03/2015
Professor Arthur T Tucker Seahorse Scientific Services Ltd. Seahorse Laboratories Ltd. Edixomed Ltd. Sky Medical Technology Ltd. & FirstKind 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.
03/04/2014
Professor David Wingate Member of Whitechapel Society for the Advancement of research in Gastroenterology Trustee of Harold Hyam Wingate Foundation
03/04/2014
Professor Atholl Johnston Positions - Various Pharma Companies Consultant, Director - Esprit Other ownership/ involvement- ASI Ltd. , Seahorse Scientific Services Ltd. Queen
01/05/2015
RES Committee London - City & East Annual Report Page 7
Mary University of London
Dr Miran Epstein None 03/04/2015
Ms Alison Eden 100% owner of Alison Brand - sometimes writes patient information/interviews sites, advises on recruitment/retention strategy. Employee of ICON. Contract Research Organisation.
02/02/2014 04/06/2015
Dr Eleni Palazidou Reviews research applications for NIHR
27/02/2014 13/04/2015
Ms Janelle Hill None 10/12/2014
Professor Kim Piper None 27/02/2014
Professor Malcolm Law None 03/04/2015
RES Committee London - City & East Annual Report Page 8
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 03/04/2014 12
May 01/05/2014 14
June 05/06/2014 14
July 03/07/2014 16
September 04/09/2014 14
October 02/10/2014 15
November 06/11/2014 16
December 04/12/2014 12
January 08/01/2015 10
February 05/02/2015 13
March 05/03/2015 13
11 full committee meetings were held during the reporting period.
Month Date Number of Members Present
at Meeting
April 24/04/2014 3
May 29/05/2014 4
June 26/06/2014 5
July 24/07/2014 4
September 25/09/2014 5
October 24/10/2014 6
November 26/11/2014 5
December 15/12/2014 4
January 22/01/2015 4
February 19/02/2015 3
March 19/03/2015 3
11 proportionate review sub-committee meetings were held during the reporting period.
Month Date Number of Members Present
at Meeting
April 14/04/2014 4
May 05/05/2014 3
May 16/05/2014 4
June 04/06/2014 3
June 23/06/2014 2
July 16/07/2014 4
August 08/08/2014 2
August 18/08/2014 4
September 23/09/2014 2
RES Committee London - City & East Annual Report Page 9
Details of inquorate meeting held:01 April 2014 - 31 March 2015
October 13/10/2014 3
October 31/10/2014 3
November 12/11/2014 2
November 20/11/2014 4
December 05/12/2014 3
December 12/12/2014 2
December 18/12/2014 2
January 13/01/2015 2
January 23/01/2015 3
January 30/01/2015 3
February 12/02/2015 3
February 23/02/2015 2
March 06/03/2015 3
March 16/03/2015 3
March 27/03/2015 3
24 sub-committee meetings were held during the reporting period.
0
RES Committee London - City & East Annual Report Page 10
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 Louise Abrams 8
Dr Chandan Alam 9
Dr Marie E Bardsley 9
Ms Clare Barron 7
Mr James Batchelor 2
Ms Jane Batchelor 8
Dr Ayse Baxter 8
Dr Luis Beltran 8
Mr Frank Cross 7
Ms Alison Eden 3
Dr Miran Epstein 1
Ms Janelle Hill 4
Ms Lisa Johnson 8
Professor Atholl Johnston 7
Dr John Keen 5
Professor Malcolm Law 5
Mr John Lynch 7
Mr Roger Maran 9
Dr Dylan Morrissey 7
Dr Eleni Palazidou 4
Professor Kim Piper 1
Mr Roy Sinclair 4
Professor Arthur T. Tucker 6
Ms Brigid Tucker 7
Dr Ariel Zosmer 3
Name Number of
Meetings
Attended
Dr Louise Abrams 1
Ms Jane Batchelor 5
Mr James Batchelor 2
Dr Ayse Baxter 2
Ms Alison Eden 1
Ms Janelle Hill 1
Professor Atholl Johnston 1
Dr John Keen 4
Mr John Lynch 1
Mr Roger Maran 6
Dr Dylan Morrissey 3
Professor Kim Piper 8
Mr Roy Sinclair 1
RES Committee London - City & East Annual Report Page 11
Attendance of Members at sub-committee meetings: 01 April 2014 - 31 March 2015
Professor Arthur T. Tucker 4
Ms Brigid Tucker 2
Dr Ariel Zosmer 4
Name Number of
Meetings
Attended
Dr Louise Abrams 6
Ms Clare Barron 1
Dr Ayse Baxter 9
Mr Frank Cross 1
Ms Alison Eden 1
Ms Janelle Hill 1
Mrs Lisa Johnson 2
Professor Atholl Johnston 5
Dr John Keen 13
Mr Roger Maran 5
Dr Dylan Morrissey 1
Mr Roy Sinclair 12
Professor Arthur T. Tucker 10
Ms Brigid Tucker 2
RES Committee London - City & East Annual Report Page 12
Training 01 April 2014 - 31 March 2015
Name of Member Date Event(s) attended
Dr Louise Abrams 11/03/2015 London Training Event
Dr Chandan Alam 05/09/2014 Joint Oxford REC Training
Dr Chandan Alam 11/03/2015 London - City & East REC Training Day
Dr Marie E Bardsley 05/09/2014 Joint Oxford REC Training
Dr Marie E Bardsley 11/03/2015 London - City & East REC Training Day
Ms Clare Barron 20/05/2014 New Members Induction
Ms Clare Barron 11/03/2015 London - City & East REC Training Day
Dr Ayse Baxter 11/03/2015 London - City & East REC Training Day
Dr Luis Beltran 11/03/2015 London - City & East REC Training Day
Mr Frank Cross 26/11/2014 The 2014 Vascular Society Annual Meeting
Ms Alison Eden 05/09/2014 Oxford A training day
Ms Janelle Hill 11/03/2015 London - South East training day
Mrs Lisa Johnson 05/09/2014 Joint Oxford Training
Dr John Keen 11/03/2015 London - City & East REC Training Day
Mr John Lynch 11/03/2015 London - City & East REC Training Day
Mr Roger Maran 11/03/2015 London - City & East REC Training Day
Dr Dylan Morrissey 06/11/2014 Self Study (Reading) - Ben Goldacre - Bad Science
Dr Eleni Palazidou 11/03/2015 London Training Event
Mr Roy Sinclair 11/03/2015 London - City & East REC Training Day
Ms Brigid Tucker 11/03/2015 London Training Event
Dr Ariel Zosmer 11/03/2015 London - City & East REC Training Day
Ms Jane Batchelor 06/11/2014 Self-Study – NRES MCA and HTA Course
RES Committee London - City & East Annual Report Page 13
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 30 44.12
Phase 1 0 0.00
Gene Therapy 0 0.00
Research Tissue Bank (including renewals) 2 2.94
Research Database (including renewals) 0 0.00
Others 36 52.94
Total Applications Reviewed 68 100
Number of applications made invalid by the REC Manager 0
Number of applications withdrawn prior to the meeting 1
Number of student applications reviewed 12
Number of paediatric applications reviewed 10
Number of device applications reviewed 3
Number of prisoner applications reviewed 0
Number of applications involving adults unable consent reviewed 0
Number of applications reviewed that are funded by the US DHHS 3
Number of qualitative applications reviewed 3
Decisions taken at meetings following review of
applications
Number %
Favourable Opinion with Standard Conditions 1 1.47
Favourable Opinion with Additional Conditions 9 13.24
Unfavourable Opinion 5 7.35
Provisional Opinion 51 75.00
Provisional Opinion Pending Consultation with Referee 2 2.94
Total 68 100
Number of studies sent back to full committee meeting for final opinion
0
RES Committee London - City & East Annual Report Page 14
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 63.24
Further Information Favourable Opinion with Additional Conditions
8 11.76
Further Information Unfavourable Opinion 0 0.00
Favourable Opinion with Standard Conditions 1 1.47
Favourable Opinion with Additional Conditions 9 13.24
Unfavourable Opinion 5 7.35
Provisional Opinion 1 1.47
Provisional Opinion Pending Consultation with Referee 0 0.00
Further Information response not complete 0 0.00
No decision entered on system 0 0.00
Number of studies withdrawn after the meeting 1 1.47
Total 68 100
RES Committee London - City & East Annual Report Page 15
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 0
Number of studies withdrawn prior to the meeting 2
Number of student applications reviewed 15
Number of paediatric applications reviewed 3
Number of device applications reviewed 1
Number of qualitative applications reviewed 6
Total Applications Reviewed 35
Decisions taken at proportionate review sub-
committee meetings
Number %
Favourable Opinion with Standard Conditions 9 25.71
Favourable Opinion with Additional Conditions 7 20.00
No Opinion transfer to full committee for review 2 5.71
Provisional Opinion 16 45.71
Unfavourable Opinion 1 2.86
Total 35 100
RES Committee London - City & East Annual Report Page 16
Table 8: Other Management Information for the reporting period:
Average number of applications reviewed per full meeting 6.18
Number of applications for full ethical review 67
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 8
Number of applications over 40 days as a % of total 11.76%
Number of days taken to final decision – average (mean) 35
Number of proportionate review applications for ethical
review
33
Number of proportionate review applications for ethical
review over 14 days
1
Number of proportionate review applications over 14 days as
a % of total
3.03%
Number of SSAs (non-Phase 1) reviewed 22
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 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
0.00%
Number of substantial amendments reviewed 146
Number of substantial amendments over 35 days 1
Number of substantial amendments over 35 days as a % of
total substantial amendments
0.68%
Number of substantial amendments over 28 days 24
Number of substantial amendments over 28 days as a % of
total substantial amendments
16.44%
Number of modified amendments reviewed 2
Number of modified amendments over 14 days 0
Number of modified amendments over 14 days as a % of
total modified amendments
0.00%
Number of minor amendments received 22
Number of substantial amendments received for information 0
Number of substantial amendments received for new
sites/PIs
32
Number of annual progress reports received 15
Number of safety reports received 22
Number of Serious Adverse Events received 0
Number of final reports received 5
RES Committee London - City & East Research Ethics Committee Annual Report Page 17
Table 9.1: Breakdown of current status of all full applications reviewed within the reporting period
Further Information Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
14/LO/0465 PATRIOT 35
14/LO/0485 Asthma Viral Challenge study 38
14/LO/0506 Investigating immunogenicity to biopharmaceutics version 2 54
14/LO/0629 Tooth loss in periodontitis patients 37
14/LO/0641 1335P1514: S-222611 in combination with anticancer treatments 55
14/LO/0667 MK-5172/MK-8742 in Subjects with HCV/HIV Co-Infection 33
14/LO/0668 Automated brain morphometry for dementia diagnosis (BrainMeasure) 37
14/LO/0680 MEDI4736 in NSCLC (D4191C00003, ATLANTIC Study) 34
14/LO/0706 Dual phase gel on erosion damaged enamel 37
14/LO/0750 CIRCULER, Version 1.0 31
14/LO/0826 A case-control evaluation of the NHS Bowel Cancer Screening Programme 38
14/LO/0852 Brain in Hand – how does it help keep the day on track? 35
14/LO/1139 A Phase 2 Study to Evaluate AMG 334 in Chronic Migraine Prevention 35
14/LO/1182 Iloprost in patients with Eisenmenger Syndrome 39
14/LO/1184 Masitinib/Placebo + Gemcitabine + FOLFIRI.3 in Pancreatic Cancer V1 36
14/LO/1185 Testing a new stepwise strategy for the management of renal anaemia 35
14/LO/1189 Pfizer B3281006-Ph 3 PF-05280586 vs Rituximab in low tumour burden FL 50
14/LO/1193 Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia 25
14/LO/1432 Function Following Laser for Anal Neoplasia (FLAN) 34
14/LO/1514 An Open Label Study of COR—003 on the treatment of Cushing's syndrome 41
14/LO/1519 FACTS 39
14/LO/1578 DMID 11-0069 Valgan Toddler, Version 2.0 Dated 30 May 2014 29
14/LO/1736 Stress Echocardiography vs Exercise ECG in women with chest pain 39
14/LO/1737 U31287-A-U106 37
14/LO/1740 VIRTUE 39
14/LO/1742 prospective multicenter Zimmer TM Ardis post market surveillance study 19
14/LO/1744 Lipid-riche Plaque study, version 1.10 39
14/LO/1786 CapaCiTY Study 1- Chronic Constipation Treatment Pathway 34
14/LO/1870 Genetic Analysis of Adult intraocular tumors 28
14/LO/1882 (duplicate) UCLID 39
14/LO/1923 T2347(Latanoprost/Timolol) vs Xalacom® in glaucoma/ocular hypertension 27
14/LO/1939 Octreotide as prophylaxis for lapatinib-capecitabine related diarrhoea 48
RES Committee London - City & East Research Ethics Committee Annual Report Page 18
14/LO/2036 WP29158-MPDL3280A & Erlotinib in advanced Non-Small Cell Lung Cancer 34
14/LO/2101 GWEP1330 - A Study of GWP42006 in people with focal seizures 29
14/LO/2125 Simeprevir and Daclastasvir in Hep-C Advanced Liver Disease - COMMIT 35
14/LO/2137 (INSIGHT 006: FLU-IVIG) 31
14/LO/2195 ARB v1.0 24
15/LO/0023 Cardamon trial 36
15/LO/0024 Abbreviated Mentalization Based Therapy in Borderline Crises(AMBIC) 40
15/LO/0205 Auditory Verbal Hallucinations in Bipolar Disorder 22
15/LO/0210 CR-AIR-007 47
15/LO/0363 The role of LLT1 in immune evasion and hepatocellular carcinoma 34
15/LO/0386 Changing Heads, Changing Faces (Version 1) 38
Further Information Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
14/LO/0855 673-201 Study of BMN 673 in patients with Germline BRCA mutation 40
14/LO/1178 Assessment of Multiple Sclerosis in Routine Clinical Practice v1 35
14/LO/1443 Pyrenees 49
15/LO/0005 TASMA: Targets of Bronchial Thermoplasty in Severe Asthma 38
15/LO/0159 SelPac Version 1 39
15/LO/0302 First-in-Human Study of TAK-659 in Advanced Solid Tumor and Lymphoma 34
15/LO/0380 SUNSHIELD 40
15/LO/0381 Immuni-D 40
Further Information Unfavourable Opinion
REC Reference Title Number of Days on Clock
Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
14/LO/1351 Chronic neuropathic lower limb pain and use of spinal cord stimulator. 28
Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
RES Committee London - City & East Research Ethics Committee Annual Report Page 19
14/LO/0527 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC 28
14/LO/0836 The experiences of families following hemispheric surgery 28
14/LO/2009 Assessment of validity of PEDI-CAT for children with cerebral palsy 19
14/LO/2149 Distress Thermometer for adult patients with diverse sex development 24
15/LO/0006 Open-Label Extension to the Odanacatib Fracture Trial (PN018) 58
15/LO/0007 MK-5172 + MK-8742 in HCV-infected subjects with hepatic insufficiency (CP-B) 29
15/LO/0022 Experiences of Adults with Grandiose Beliefs 32
15/LO/0182 TIGER-3 28
15/LO/0202 A case study of a pre-school child who gained too much weight-Version1 28
Unfavourable Opinion
REC Reference Title Number of Days on Clock
14/LO/0493 Brain in Hand - evaluation 29
14/LO/0498 Bright Spots:Local Authorities delivering positive care experiences v2 30
14/LO/0563 Study of MMX® Mesalamine/Mesalazine in Paediatric Ulcerative Colitis 28
14/LO/1383 UCLID 28
14/LO/2134 Do all HEART scores beat the same? 23
Provisional Opinion
REC Reference Title Number of Days on Clock
15/LO/0355 Immune signatures associated with rapid beta cell loss in T1D n/a
Provisional Opinion Pending Consultation with Referee
REC Reference Title Number of Days on Clock
Further information response not complete
REC Reference Title Number of Days on Clock
Withdrawn after the meeting
REC Reference Title Number of Days on Clock
14/LO/1844 Bright Spots:Local Authorities delivering positive care experiences v2 34
RES Committee London - City & East Research Ethics Committee Annual Report Page 20
Table 9.2: Breakdown of current status of all PRS applications reviewed within the reporting period
Further Information Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
14/LO/1044 Epidemiology and management of premenstrual symptoms in the community 13
14/LO/1183 Smart-device apps as memory aids 6
14/LO/1188 Adherence to Eccentric Exercise for Achilles Tendon Pain: v1 10
14/LO/1359 Visualizing Uncertainty Among Laypersons and Experts (VISUALizE ) 12
14/LO/1772 The prostate cancer patient experience from biopsy to treatment. 14
14/LO/1775 PIPPIN study - models of PPI in LTC services 1
14/LO/1953 Exploring late-effects issues after radiotherapy for breast cancer 13
14/LO/1960 Intervention development for cluster randomised trial in CPRD (eCRT2) 14
15/LO/0193 Efficacy of First Aid Treatment of Acute Apical Abscess (AAA) 9
15/LO/0366 Isoflurane anaesthesia during cardiopulmonary bypass 14
15/LO/0367 Improving auditory outcomes 13
15/LO/0544 Tocilizumab effects on adipokines in Rheumatoid Arthritis 11
Further Information Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
15/LO/0187 Acoustic analysis of nasal airflow in normal and abnormal subjects(V2) 14
15/LO/0189 TAC Registry (Study Name: CHORUS) 15
Further Information Unfavourable Opinion
REC Reference Title Number of Days on Clock
Favourable Opinion with Standard Conditions
REC Reference Title Number of Days on Clock
14/LO/1777 Development of novel treatments for cancer based on T-cell receptors 10
14/LO/1957 Version 9:Nasolabial soft tissue changes with upper jaw surgery 13
RES Committee London - City & East Research Ethics Committee Annual Report Page 21
14/LO/2167 Adalimumab (HUMIRA®) use in patients with Ulcerative Colitis 9
14/LO/2184 Impact of Physical activity and Vitamin D on osteoarthritic knee pain 9
14/LO/2286 Particle sizing of masticated tree nuts - cashews and walnuts (v1.0) 3
14/LO/2290 Neurophysiology of fatigue in people with multiple sclerosis 10
15/LO/0204 Nutrition impact symptoms score as a malnutrition screening tool 8
15/LO/0541 Pragmatic versus electrocardiographic-guided loop recorder position 4
15/LO/0545 CARAT - RTSY03 9
Favourable Opinion with Additional Conditions
REC Reference Title Number of Days on Clock
14/LO/0743 Air Pollution in Lung Transplantation 10
14/LO/0745 Influence of varying tooth shape on perceived smile aesthetics 10
14/LO/1037 Evaluation of the Effect of the OBJ Technology on Fluoride Uptake V3.0 8
14/LO/1350 GARFIELD-VTE 4
14/LO/1352 Placental autoimmunity and fetal loss. 8
14/LO/2185 Analysis of natural killer cell status in Alemtuzumab MS patients 8
14/LO/2274 The effects of MI training on physiotherapists' behaviour and beliefs 7
Unfavourable Opinion
REC Reference Title Number of Days on Clock
14/LO/1778 The effect of exposure to mercury on disease activity in SLE 13
Provisional Opinion
REC Reference Title Number of Days on Clock
15/LO/0359 Using Ultrasound to assess tonsil size in children n/a
15/LO/0542 HRQoL, Ethnicity & PCOS n/a
Further information response not complete
REC Reference Title Number of Days on Clock
Withdrawn after the meeting
RES Committee London - City & East Research Ethics Committee Annual Report Page 22
REC Reference Title Number of Days on Clock
RES Committee London - City & East Research Ethics Committee Annual Report Page 23
Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting period
Favourable opinion
Amendment REC
Reference
Title Version Date Number of Days on
Clock
04/Q0603/1/AM44 ASPECT Amendment number115_EndOf
Study
01/05/2014 30
04/Q0603/1/AM48 ASPECT Substantial Amendment
January 2015
20/01/2015 13
06/Q1603/7/AM12 Chemoprevention of Premalignant Intestinal Neoplasia 8 03/02/2015 6
07/H0703/160/AM62 Study of MK822 in osteoporotic fracture prevention AM62 Substantial Amendment 58
09/04/2014 24
07/H0703/160/AM63 Study of MK822 in osteoporotic fracture prevention AM63 Substantial Amendment 60
10/07/2014 18
07/H0703/160/AM64 Study of MK822 in osteoporotic fracture prevention 62 09/10/2014 25
07/Q0603/8/AM14 Phase III, placebo-controlled study in subjects with multiple myeloma
AM14 Substantial Amendment
27/03/2014 28
09/H0703/101/AM11 INSIGHT H1N1v Outpatient Study (FLU 002) Substantial Amendment 8
dated
24/06/2014 12
09/H0703/72/AM03 Hypoglycaemia and brain injury VN1 2 09/06/2014 12
09/H0703/72/AM04 Hypoglycaemia and brain injury VN1 3 03/03/2015 9
10/H0703/107/AM17 A3921061 Long Term Safety & Tolerability of 2 oral doses of CP-690,550
13 Oct 2014 13/10/2014 29
10/H0703/107/AM18 A3921061 Long Term Safety & Tolerability of 2 oral doses of CP-690,550
23/02/2015 23/02/2015 14
10/H0703/14/AM02 Reflux studies on patients with voice disorders 02 15/07/2014 14
10/H0703/30/AM04 Association of Genetic Variation and Neurobiological Change with BPSD
4 17/12/2014 22
10/H0703/45/AM05 CAR-PET 5 12/01/2015 5
10/H0703/56/AM14 Phase Ib/II Eribulin Mesylate Bladder Cancer 12/05/2014 12/05/2014 12
10/H0703/62/AM03 QST and lumbar radiculopathy AM03 Substantial Amendment
23/04/2014 16
10/H0703/79/AM03 CABANA Trial - Version 3.3 -03-March-2010 AM 03 Substantial 31/07/2014 18
RES Committee London - City & East Research Ethics Committee Annual Report Page 24
Amendment 03
10/H0704/43/AM02 Myocardial inflammation and signaling in atrial fibrillation. Am02 Substantial Amendment 2 d
12/09/2014 32
10/H0704/43/AM03 Myocardial inflammation and signaling in atrial fibrillation. 3 23/03/2015 23
11/H0703/10/AM05 An Exploratory Clinical and Genetic Study of Cone Disorders Substantial Amendment 4
13/01/2015 19
11/LO/0326/AM02 FIT for Follow-up Study AM02 Substantial Amendment
01/04/2014 28
11/LO/0948/AM03 Comparison of DES in Patients with Diabetes Mellitus 2 02/05/2014 10
11/LO/1226/AM11 Study of DE-109 Intravitreal Injections in patients with Uveitis V1
Substantial Amendment 5:
31.05
09/05/2014 27
11/LO/1559/AM21 SPIKE v4 20 02/10/2014 30
11/LO/1595/AM05 FGFR Substantial Amendment 5:
26/06/2014 15
11/LO/1740/AM13 A4001095 Maraviroc comparator study in antiretroviral naive HIV pts
Substantial Amendment dated
8
08/04/2014 34
12/LO/0315/AM07 Phase 2 Study of Anti-CCR4 MBA KW-0761 in subjects with PTCL
CTA Amendment 5, March 2014
07/04/2014 29
12/LO/0482/AM03 Peruse: Global safety study with pertuzumab in Her2+ advanced BC
AM03 06/08/2014 34
12/LO/0593/AM05 Daratumumab with lenalidomide and dexamethasone in multiple myeloma
AM05 Protocol Amendment 5 date
17/03/2014 32
12/LO/0593/AM06 Daratumumab with lenalidomide and dexamethasone in multiple myeloma
AM06 Substantial Amendment
30/01/2015 26
12/LO/0794/AM05 CHR258 in HCC Substantial Amendment 3 - 29
J
20/02/2015 13
12/LO/0944/AM04 Neonatal discharge package to increase parental confidence Substantial Amendment dated
14
14/05/2014 17
12/LO/0949/AM09 C16010: Phase 3 study of MLN9708 in Multiple Myeloma 9 20/06/2014 52
12/LO/0949/AM10 C16010: Phase 3 study of MLN9708 in Multiple Myeloma AM10 Substantial Amendment - P
07/08/2014 4
12/LO/1159/AM04 Randomised Control Trial of Aquamantys vs Electrocautery in Substantial 15/07/2014 27
RES Committee London - City & East Research Ethics Committee Annual Report Page 25
TKR Amendment 3 dated
12/LO/1159/AM05 Randomised Control Trial of Aquamantys vs Electrocautery in TKR
3 Final 29/08/2014 12
12/LO/1168/AM13 R2W: Randomised phase 2 trial in Waldenstrom macroglobulinaemia
AM13 Substantial Amendment
26/09/2014 12
12/LO/1492/AM05 Life Study Substantial Amendment 4
21/03/2014 28
12/LO/1492/AM06 Life Study Substantial Amendment 5.0
date
04/04/2014 21
12/LO/1492/AM07 Life Study 6.0 01/12/2014 23
12/LO/1492/AM08 Life Study 7.0, dated 23rd February 2015
23/02/2015 10
12/LO/1653/AM02 NEPTUNE 2 15/07/2014 21
12/LO/1717/AM07 ZEBRA Substantial Amendment 05
dated
04/06/2014 18
12/LO/1717/AM08 ZEBRA Substantial Amendment 6
13/06/2014 27
12/LO/1717/AM10 ZEBRA Substantial Amendment 7
dated
28/11/2014 14
13/LO/0009/AM03 HRV16 challenge study to examine JNJ-43260295 in healthy subjects
AM03 Substantial Amendment 2 d
25/04/2014 26
13/LO/0033/AM15 GO28509 PEGGY - Phase 2 study of GDC-0941 in metastatic breast cancer
13, IB7 July 2014 10/10/2014 26
13/LO/0150/AM04 The regorafenib in patients with hepatocellular carcinoma. Substantial Amendment dated
11
11/12/2014 12
13/LO/0315/AM03 BAMI 4.0 31/10/2014 22
13/LO/0393/AM02 INSIGHT: Investigation into biomarkers to predict preterm birth SA2: 14/04/14 29/04/2014 28
13/LO/0393/AM03 INSIGHT: Investigation into biomarkers to predict preterm birth 3 29/09/2014 27
13/LO/0549/AM04 FG-4592 in the Treatment of Anemia in Chronic Kidney Disease Patients
4 13/06/2014 27
13/LO/0549/AM06 FG-4592 in the Treatment of Anemia in Chronic Kidney 6 19/12/2014 22
RES Committee London - City & East Research Ethics Committee Annual Report Page 26
Disease Patients
13/LO/0555/AM03 Brain in Pain IV (FM,NCCP) 3 14/03/2014 22
13/LO/0555/AM04 Brain in Pain IV (FM,NCCP) AM04 Substantial Amendment 04
19/09/2014 27
13/LO/0582/AM05 Abiraterone with Different Steroid Regimens in Prostate Cancer
4 20/11/2014 26
13/LO/0582/AM06 Abiraterone with Different Steroid Regimens in Prostate Cancer
5 06/03/2015 25
13/LO/0727/AM02 LDK378 in children with malignancies that have ALK alteration 3 14/08/2014 25
13/LO/0817/AM05 Validation of a scale of GPs’ reassurance during LBP consultations
AM05 Substantial Amendment 5 d
25/04/2014 26
13/LO/0908/AM07 Enzalutamide in Triple Negative Breast Cancer AM07 Substantial Amendment
29/05/2014 24
13/LO/0908/AM08 Enzalutamide in Triple Negative Breast Cancer Substantial Amendment dated
26
26/01/2015 28
13/LO/0926/AM03 Phase 1 study to evaluate safety and efficacy of BMN 190 AM03 Substantial Amendment Cha
11/07/2014 27
13/LO/0926/AM04 Phase 1 study to evaluate safety and efficacy of BMN 190 Amendment 4 15/12/2014
15/12/2014 1
13/LO/0926/AM05 Phase 1 study to evaluate safety and efficacy of BMN 190 Amendment 5 dated 27 Jan 2015
27/01/2015 28
13/LO/1167/AM02 Setting survivorship in context: Life after cancer treatment AM02 Substantial Amendment 02
04/06/2014 23
13/LO/1207/AM01 Stereotactic radiotherapy for wet AMD (STAR) 1 07/11/2014 10
13/LO/1245/AM05 156-12-203: Phase I Tolvaptan in subjects with SIADH (Hormone)
3 02/01/2015 8
13/LO/1284/AM01 ROX CONTROL HTN REGISTRY: Protocol RH-03 Version 1.0, June 19, 2013
AM01 Substantial Amendment 01
11/04/2014 8
13/LO/1284/AM02 ROX CONTROL HTN REGISTRY: Protocol RH-03 Version 1.0, June 19, 2013
Amendment 2 dated 05 Sep 2014
05/09/2014 29
13/LO/1284/AM04 ROX CONTROL HTN REGISTRY: Protocol RH-03 Version 1.0, June 19, 2013
3 06/11/2014 11
13/LO/1399/AM03 Brain in Pain III (CFS) Substantial Amendment 3
19/09/2014 27
13/LO/1401/AM02 FORECAST - Focal Recurrent Assessment and Salvage AM02 Substantial 07/11/2014 31
RES Committee London - City & East Research Ethics Committee Annual Report Page 27
Treatment Amendment
13/LO/1401/AM03 FORECAST - Focal Recurrent Assessment and Salvage Treatment
3 14/01/2015 27
13/LO/1401/AM04 FORECAST - Focal Recurrent Assessment and Salvage Treatment
Version 4 24/02/2015
11/03/2015 20
13/LO/1437/AM01 Phase I/II study of [124I]mIBG PET/CT in neuroblastoma. AM01 Substantial Amendment 01
08/07/2014 16
13/LO/1437/AM02 Phase I/II study of [124I]mIBG PET/CT in neuroblastoma. AM02 Substantial Amendment
29/01/2015 10
13/LO/1437/AM03 Phase I/II study of [124I]mIBG PET/CT in neuroblastoma. 20/03/2015 11
13/LO/1505/AM01 ICORG 11-10/TH v THL AM01 Substantial Amendment
12/01/2015 12
13/LO/1531/AM02 Medicines management in primary care 2, 24th October 20
14
27/10/2014 5
13/LO/1557/AM01 Circulating Tumour Cells in Somatuline Autogel treated NET patients
Substantial Amendment 1.0:
06.
06/05/2014 9
13/LO/1557/AM02 Circulating Tumour Cells in Somatuline Autogel treated NET patients
2.0 29/01/2015 28
13/LO/1685/AM02 A study of the mechanisms that give rise to vascular disease V2, 2nd Sept 2014 11/09/2014 32
13/LO/1720/AM02 Enzalutamide in Combination with Exemestane in Advanced Breast Cancer
2 29/05/2014 24
13/LO/1720/AM03 Enzalutamide in Combination with Exemestane in Advanced Breast Cancer
3 26/01/2015 28
13/LO/1734/AM01 Experiences of Hearing Voices Network groups, recovery & group process
AM01 Substantial Amendment 01
30/05/2014 13
13/LO/1760/AM01 BAMI Platelet Sub-study AM01 Substantial Amendment 01
23/05/2014 31
13/LO/1885/AM01 Patient Evaluation of the NHS Health Check Programme AM01 Substantial Amendment 01
10/09/2014 16
13/LO/1943/AM01 PDOPPS 1 04/11/2014 3
13/LO/1943/AM02 PDOPPS 2 15
14/LO/0021/AM01 CE Mark Home Self-Test finger blood Total WBC, HGB, GRN, + Temperature
AM01 Substantial Amendment 01
23/01/2015 18
14/LO/0122/AM02 Safety, tolerability & pharmacokinetics of regorafenib in Am1 final 08/08/2014 35
RES Committee London - City & East Research Ethics Committee Annual Report Page 28
paediatrics
14/LO/0122/AM04 Safety, tolerability & pharmacokinetics of regorafenib in paediatrics
Updated dosing diary, 15906,
13/11/2014 9
14/LO/0122/AM05 Safety, tolerability & pharmacokinetics of regorafenib in paediatrics
4 03/12/2014 14
14/LO/0132/AM01 Robotic Surgery After Focal Ablation Therapy (RAFT) Am01 Substantial Amendment 01
18/11/2014 24
14/LO/0141/AM02 iMAP2 1 15/08/2014 28
14/LO/0141/AM03 iMAP2 2 12/02/2015 10
14/LO/0141/AM04 iMAP2 3 09/12/2014 4
14/LO/0165/AM01 Sickle Cell Analgesia Protocol Evaluation (SCAPE) 1 19/03/2015 27
14/LO/0235/AM02 Investigating women's views on the management of a breech pregnancy V1
2 23/06/2014 32
14/LO/0317/AM01 NeoAdapt 1 AM01 Substantial Amendment 01
29/05/2014 17
14/LO/0318/AM01 NeoAdapt 2 AM01 Substantial Amendment 01
29/05/2014 17
14/LO/0319/AM01 NeoAdapt 3 Am01 Substantial Amendment 01
29/05/2014 17
14/LO/0418/AM01 CEDAR AM01 Substantial Amendment 01
23/05/2014 24
14/LO/0465/AM01 PATRIOT AM01 Substantial Amendment 01
25/09/2014 28
14/LO/0485/AM04 Asthma Viral Challenge study 2 13/08/2014 30
14/LO/0506/AM01 Investigating immunogenicity to biopharmaceutics version 2 Revised VersionÂ
3, 27/03/2015
31/03/2015 21
14/LO/0527/AM04 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC 1 15/08/2014 25
14/LO/0527/AM05 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC 2 05/11/2014 12
14/LO/0527/AM06 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC Substantial Amendment dated
22
22/01/2015 25
14/LO/0527/AM07 GO28754 Anti-PDL1 in locally advanced or metastatic NSCLC Substantial Amendment #4
12/02/2015 8
14/LO/0641/AM01 1335P1514: S-222611 in combination with anticancer treatments
1 10/09/2014 33
RES Committee London - City & East Research Ethics Committee Annual Report Page 29
14/LO/0641/AM02 1335P1514: S-222611 in combination with anticancer treatments
UK EC SA#3 Protocol v5.0
20/03/2015 24
14/LO/0667/AM01 MK-5172/MK-8742 in Subjects with HCV/HIV Co-Infection Substantial Amendment 1
dated
30/06/2014 11
14/LO/0667/AM02 MK-5172/MK-8742 in Subjects with HCV/HIV Co-Infection Am02 Substantial Amendment 02
29/09/2014 27
14/LO/0668/AM01 Automated brain morphometry for dementia diagnosis (BrainMeasure)
1 04/02/2015 0
14/LO/0680/AM02 MEDI4736 in NSCLC (D4191C00003, ATLANTIC Study) 2 11/09/2014 29
14/LO/0680/AM03 MEDI4736 in NSCLC (D4191C00003, ATLANTIC Study) 3 10/12/2014 21
14/LO/0680/AM04 MEDI4736 in NSCLC (D4191C00003, ATLANTIC Study) 4 16/02/2015 16
14/LO/0750/AM01 CIRCULER, Version 1.0 1 28/07/2014 30
14/LO/1139/AM01 A Phase 2 Study to Evaluate AMG 334 in Chronic Migraine Prevention
Substantial Amendment 01
10/12/2014 13
14/LO/1182/AM01 Iloprost in patients with Eisenmenger Syndrome 1 17/09/2014 26
14/LO/1182/AM02 Iloprost in patients with Eisenmenger Syndrome 2 09/01/2015 22
14/LO/1184/AM01 Masitinib/Placebo + Gemcitabine + FOLFIRI.3 in Pancreatic Cancer V1
AM01 27/10/2014 19
14/LO/1184/AM04 Masitinib/Placebo + Gemcitabine + FOLFIRI.3 in Pancreatic Cancer V1
Substantial Amendment 3
26/01/2015 23
14/LO/1185/AM01 Testing a new stepwise strategy for the management of renal anaemia
1 01/10/2014 28
14/LO/1193/AM01 Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia
1 14/11/2014 34
14/LO/1193/AM02 Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia
AM02 Substantial Amendment IB
21/01/2015 5
14/LO/1193/AM03 Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia
Substantial Amendment
25/02/2015 15
14/LO/1443/AM02 Pyrenees Substantial Amendment
21/01/2015 14
14/LO/1514/AM01 An Open Label Study of COR—003 on the treatment of Cushing's syndrome
AM01 Substantial Amendment 01
03/02/2015 11
14/LO/1737/AM01 U31287-A-U106 13/01/2015 20
14/LO/1939/AM01 Octreotide as prophylaxis for lapatinib-capecitabine related diarrhoea
AM01 Substantial Amendment 01
03/02/2015 12
RES Committee London - City & East Research Ethics Committee Annual Report Page 30
Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period
14/LO/2167/AM01 Adalimumab (HUMIRA®) use in patients with Ulcerative Colitis
Substantial Amendment 01
22/01/2015 17
14/LO/2184/AM01 Impact of Physical activity and Vitamin D on osteoarthritic knee pain
AM01 Substantial Amendment 1
03/02/2015 13
15/LO/0006/AM01 Open-Label Extension to the Odanacatib Fracture Trial (PN018)
SA01 05/02/2015 9
15/LO/0023/AM02 Cardamon trial 1 26/03/2015 26
15/LO/0182/AM02 TIGER-3 2.1 17/03/2015 14
MSA RETRO 11 1 SB/AM07
rotocol to identify suitable volunteers for inclusion Retroscreen Pane
18 30/06/2014 10
MSA RETRO 11 1 SB/AM08
rotocol to identify suitable volunteers for inclusion Retroscreen Pane
19 04/08/2014 28
Unfavourable opinion
Amendment REC
Reference
Title Version Date Number of Days on
Clock
07/Q0603/29/AM09 ACIT II: Version 1.3 8.0 (06/11/2014) 09/02/2015 34
10/H0704/78/AM04 The Relationship between gut microbiota and diseases (version1)
4 15/01/2015 33
11/LO/0241/AM07 Parkinson’s Progression Markers Initiative 7 16/06/2014 22
12/LO/0794/AM04 CHR258 in HCC 4 25/09/2014 28
13/LO/1801/AM01 The Men’s Safer Sex (MenSS) Trial: a website to increase condom use
AM01 Substantial Amendment 01
23/05/2014 34
14/LO/0235/AM01 Investigating women's views on the management of a breech pregnancy V1
AM01: Amendment 1
07/04/2014 29
Favourable opinion timeline
Amendment REC Title Version Date Number of Days on
RES Committee London - City & East Research Ethics Committee Annual Report Page 31
Reference Clock
11/LO/0241/AM07/1 Parkinson’s Progression Markers Initiative Modified Amendment
22/07/2014 8
13/LO/1801/AM01/1 The Men’s Safer Sex (MenSS) Trial: a website to increase condom use
Modified Amendment to
AM01 Sub
21/08/2014 7
Unfavourable opinion timeline
Amendment REC
Reference
Title Version Date Number of Days on
Clock
RES Committee London - City & East Research Ethics Committee Annual Report Page 32
Table 11: Items exceeding timelines
Full applications for ethical review over 60 day timeline
REC Reference Title Number of Days on Clock
Proportionate review applications for ethical review over 14 day timeline
REC Reference Title Number of Days on Clock
15/LO/0189 TAC Registry (Study Name: CHORUS) 15
SSAs (non Phase 1) over 25 day timeline
REC Reference Title Number of Days on Clock
SSAs (Phase 1) over 14 day timeline
REC Reference Title Number of Days on Clock
Substantial Amendments over 35 day timeline
Amendment REC
Reference
Title Version Date Number of Days on
Clock
12/LO/0949/AM09 C16010: Phase 3 study of MLN9708 in Multiple Myeloma 9 20/06/2014 52
Modified Amendments over 14 day timeline
Amendment REC
Reference
Title Version Date Number of Days on
Clock