Table 1 Salford Royal NHS Foundation Trust: Performance in initiating clinical research (HRA Approval) Reporting period 1 April March 2017
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1 Table 1 Salford Royal NHS Foundation Trust: Performance in initiating clinical research (HRA Approval) Reporting period 1 April March 2017 REC reference IRAS number Study title 16/NW/ Phase 2 open label study of SNF472 in calciphylaxis patients 16/YH/ A clinical investigation of a novel FES system 16/NW/ Phase 2 study of the safety and efficacy of CORT in the treatment of endogenous Cushings syndrome 16/NW/ A new speech and language therapy intervention for children who have Social Communication Disorder: feasibility and acceptability to service users and practitioners 14/LO/ CBYM338B2201 A possible treatment for muscle wasting after hip fracture 14/NW/ The Bedside Evaluation of Sensitive Troponin invited selected HRA Approval date confirmed by sponsor confirmed ready to start First patient first visit Benchmark met 26/04/ /08/ /08/ /08/ /08/ /08/ /08/2016 Yes N/A Reason for 07/07/ /07/ /09/ /09/ /09/ /10/ /11/2016 No No patients consented 20/06/ /08/ /10/ /10/ /10/ /10/2016 No Sponsor 17/10/ /10/ /08/ /10/ /11/ /11/ /01/2017 No NHS 01/07/ /10/ /11/ /11/ /12/ /12/2016 No NHS staff availability 14/06/ /11/ /06/ /11/ /12/ /01/ /01/2017 Yes N/A
2 (BEST) study 15/NS/ The Percutaneous nephrolithotomy, flexible Ureterorenoscopy and Extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT 16/LO/ LEAP: A 52-week twopart, open-label, multicentre, multinational study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory efficacy of GZ/SAR in combination with Cerezyme in adult patients with Gaucher disease type3 16/EE/ First in human study with participants in Pompe disease 16/YH/ CGMP - based protein substitutes in semiadherent PKU patients 16/EM/ A randomised controlled trial to evaluate the efficacy of non-thermal gas plasma (NTGP) on sub-clinical wound infection (biofilm) in 26/09/ /09/ /06/ /12/ /11/ /12/ /12/2016 No NHS staff availability 15/01/ /08/ /09/ /11/ /11/ /11/2016 No Rare disease study 03/12/ /09/ /08/ /09/ /10/ /10/ /10/2016 Yes N/A 26/05/ /08/ /10/ /08/ /10/ /12/2016 No Contracting 01/09/ /01/ /01/ /01/ /01/ /01/ /02/2017 Yes N/A
3 patients with diabetic foot ulcers compared to those treated with standard of care dressings 16/LO/ Blood glucose performance test 14/12/ /01/ /01/ /03/ /03/ /04/ /04/2017 No Contracting 16/WA/ STUMBLE trial 05/09/ /11/ /11/ /01/ /01/ /01/ /02/2017 No Sponsor 16/LO/ PRX-102 compared to Agalsidase Beta in patients with Fabry disease 16/NW/ SNFCT (CALIPSO) 16/NW/ A phase 1b/2, multicenter, double-blind (principal investigators and study subjects blinded, sponsor unblinded), placebocontrolled, randomized, singleascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of DS-1040B in subjects with acute ischemic stroke. 16/WM/ Protocol Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis (ASCEND-D) 10/07/ /10/ /09/ /01/ /01/ /02/2017 No Sponsor 02/08/ /09/ /11/ /02/ /02/ /02/2017 No Sponsor 24/10/ /12/ /10/ /02/ /02/ /02/2017 No Sponsor 26/10/ /12/ /02/ /02/ /02/2017 No Sponsor 16/NW/ Protocol /10/ /12/ /02/ /02/ /02/2017 No Sponsor
4 16/NW/ Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis (ASCEND-ND) Phase 3, randomized, open-label, activecontrolled study evaluating the oral vadadustat for the correction of anemia in subjects with non dialysisdependent chronic kidney disease (NDD- CKD) (PRO2TECTCORRECTI ON) - AKB-6548-CI /NW/ Phase 3, randomized, open-label, activecontrolled study evaluating the oral vadadustat for the maintenance treatment of anemia in subjects with nondialysis-dependent chronic kidney disease (NDD-CKD) (PRO2TECT- CONVERSION) 16/SC/ A double-blind, placebo-controlled, randomizedwithdrawal, multicenter study of the 29/09/ /11/ /10/ /02/ /03/2017 No Sponsor 29/09/ /11/ /10/ /02/ /03/2017 No Sponsor 21/11/ /11/ /09/ /02/ /02/ /02/2017 No Sponsor
5 JZP-258 in subjects with narcolepsy with cataplexy : JAZZ 16/LO/ A randomized, double-blind, placebo-controlled study to evaluate the SAGE-547 injection in the treatment of subjects with superrefractory status epilepticus 16/YH/ Protocol BI versus Humira in patients with active Crohn s disease 16/NI/ A phase I/II study to evaluate the safety and pharmacokinetics of intravenous Trappsol Cyclo (HP-?- CD) in patients with Niemann-Pick disease type C (NPC-1) 16/WM/ LEO twice weekly maintenance regimen for psoriasis vulgaris 16/SC/ A prospective international multicentre randomised controlled single blind clinical investigation of magnetically enhanced diffusion for acute ischaemic stroke(medis INTERNATIONAL) 13/10/ /12/ /10/ /02/ /02/2017 No Sponsor 13/12/ /12/ /03/ /03/ /03/2017 No Sponsor 25/11/ /11/ /11/ /03/ /03/ /03/2017 No NHS 13/01/ /01/ /01/ /03/ /03/2017 No Sponsor 02/11/ /01/ /01/ /02/ /02/ /03/2017 No Sponsor
6 17/LO/ A feasibility study to assess the effect of the PulseFlowDF in the treatment of people with diabetic foot ulcers 16/NW/ A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element supplement for children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product tolerance, palatability and compliance. 19/12/ /12/ /02/ /02/ /02/ /03/2017 No Sponsor 05/09/ /11/ /11/ /01/ /01/2017 No Contracting
Perfomance in Delivering (Commercial Trials)
Perfomance in Delivering (Commercial Trials) REC Ref IRAS ID Name of Trial Target Of? Minimum Of Maximum Of Target Date To Recruit? Total Date Of to recruit target number Recruited At of patients The Target
The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018
The Pennine Acute Hospitals NHS Trust Performance in initiating clinical research Reporting period 1 October 2017 to 30 September 2018 REC reference IRAS reference Name of trial First patient recruited?
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April March 2014
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 April 2013-31 March 2014 Research Ethics Committee Name of Trial reference number 1 08/H0906/140
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October September 2013
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 October 2012-30 September 2013 Research Ethics Committee reference number Name of Trial 1 12/NW/0321
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July June 2013
Table 1: Salford Royal NHS Foundation Trust: Performance in initiating clinical research: Reporting period 1 July 2012-30 June 2013 Name of trial Note, some study titles are shortened 1 Long-Term Study
The Pennine Acute Hospitals NHS Trust Performance in delivering clinical research Reporting period 1 October 2017 to 30 September 2018
The Pennine Acute Hospitals NHS Trust Performance in delivering clinical research Reporting period 1 October 2017 to 30 September 2018 REC reference IRAS reference Name of trial Target number of? Minimum
Performance in Initiating and Delivering Clinical Research Why are we doing this?
Performance in Initiating and Delivering Clinical Research Why are we doing this? Through the NIHR (National Institute for Health Research) the Government wishes to see a dramatic and sustained improvement
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CPMS ID IRAS Short Name Details PI Managing Specialty Sub-specialty Status Commercial/ Academic Opening Date Closure Date Total recruitment Recruitment target 2016/17 Predicted recruitment 01/04/2017-31/03/2018
Performance in Initiating and Delivering Clinical Research
Performance in Initiating and Delivering Clinical Research As a global leading centre for research in Eyes and Vision, it is a key priority to offer as many patients as possible the opportunity to get
Performance in Initiating Clinical Research
Performance in Initiating Clinical Research January 2016 December 2016 NHS Permissions Site approval Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial
Table 2: Salford Royal NHS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January December 2014
Table 2: Salford Royal HS Foundation Trust: Performance in delivering clinical research: Reporting period 1 January 2014 1 December 2014 Research Ethics Committee reference number 1 12/W/0321 2 11/LO/1986
Performance of Initiating Q South London and Maudsley NHS Foundation Trust:
Research Ethics Committee Reference Number Integrated Research Application System Number Submission Type Name of Trial Date of Receipt of Valid Research Application Date of NHS First Patient Recruited?
Date of NHS Permission. Date of First Patient Recruited. Date Site Invited
Reference of Receipt of of NHS of First 14/WA/1075 150715 NHS HeadPoST Version 2.1 23/11/2015 05/01/2016 11/01/2016 N/A 12/YH/0452 106985 NHS INCA 10/12/2015 15/01/2016 17/03/2016 N/A Excess Treatment
Performance in Initiating and Delivering Clinical Research
Performance in Initiating and Delivering Clinical Research As a global leading centre for research in Eyes and Vision, it is a key priority to offer as many patients as possible the opportunity to get
Performance in delivering Clinical Research at PHT Q3 14/15 study met the 70 day target study within 70 day target study not met 70 day target
Performance in delivering Clinical Research at PHT Q3 14/15 study met the 70 day target study within 70 day target study not met 70 day target Research Ethics Committee 14/ES/0004 ALA-BCC-CT008 - A randomized,
Target date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished.
No REC Reference IRAS No Title Target number of agreed? Target range minimum Target range maximum Target date to recruit agreed? Planned Recruitment end date Total no of recruited at the agreed target
South London and Maudsley NHS Foundation Trust: FY1819 Q2 Performance in Initiating
of First 17/YH/0195 228739 17/YH/0196 228435 17/LO/0987 215947 17/LO/1314 224111 17/WM/0441 224759 17/LO/1867 229005 A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity
Target date to recruit patients agreed? Target range minimum. Target range maximum
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date Total no of patients recruited
Scottish Medicines Consortium
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Performance of Initiating Q South London and Maudsley NHS Foundation Trust:
By of First 16/LO/1439 212222 16/EE/0318 201898 16/LO/0873 193362 16/EE/0233 188916 16/LO/1862 206680 A pilot study of two sessions responsibility intervention for auditory hallucinations A randomised
A - Nonconfirmation Suspended by Sponsor B - D - Date site. C - Closed ready to start. Permissions. Sponsor delays ied. delayed/den.
No REC Reference Number IRAS No Title Submission Type Valid Research Application Date of First Patient Recruitment Benchmark Met invited selected Approval date confirmed by sponsor confirmed A - Nonconfirmation
Performance in Initiating Clinical Research Q2 2016/17
Performance in Initiating Clinical Research Q2 2016/17 Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Date of Receipt of Valid Research Application
Target date to recruit patients agreed? Target range minimum. Target range maximum. Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date No of patients recruited
Integrated Research Application System Number. Total Number Of Study Participants Recruited. Research Ethics Committee Reference Number
Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Minimum Number Of Patients Agreed Maximum Number Of Patients Agreed Date That The Trial Closed To
A - Permissions delayed/den ied. Date site ready to start. B - Suspended by Sponsor. C - Closed D - Sponsor
No REC Reference IRAS No Number Title Date of First Patient Recruitment Benchmark Met invited selected HRA Approval date confirmed by sponsor confirmed ready to start A - Permissions delayed/den ied B
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