Date of NHS Permission. Date of First Patient Recruited. Date Site Invited
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1 Reference of Receipt of of NHS of First 14/WA/ NHS HeadPoST Version /11/ /01/ /01/2016 N/A 12/YH/ NHS INCA 10/12/ /01/ /03/2016 N/A Excess Treatment Costs need to be resolved. 11/LO/ NHS FGFR 05/01/ /01/2016 N/A Sponsor delayed until 17/02/ /WA/ NHS Biomarkers associated with post-treatment complications in cancer 05/01/ /01/2016 N/A Not NIHR adopted and therefore funding not available to support the study. We withdrew from study due to lack of funding 14/LO/ NHS PLATFORM 05/01/ /01/2016 N/A Sponsor delayed until 14/03/ /LO/ NHS ACTICCA-1 04/12/ /01/2016 N/A Sponsor delayed sending through contract 15/EE/ NHS POETIC-2 Feasibility 19/01/ /02/ /09/2016 N/A Delays in getting contracts signed 15/EE/ NHS DIAB /01/ /02/2016 N/A Sponsor delay in provision of IMP 15/NE/ NHS Simvastatin as a neuroprotective treatment for moderate PD (PD STAT) 20/01/ /02/ /06/2016 N/A Sponsor delayed until 16/03/ /WM/ NHS MMY /01/ /02/ /03/2016 N/A 15/LO/ NHS EMBARK:MDV Phase3, Enzalutamide, nonmetastatic Prostate Cancer 25/11/ /02/2016 N/A Sponsor delay in reviewing the budget and CTA. 15/LO/ NHS CANC /02/ /02/ /09/2016 N/A One patient did not fit criteria 14/SS/ NHS EMBARC: European Bronchiectasis Registry 22/02/ /02/ /03/2016 N/A Rare disease
2 Reference of Receipt of of NHS of First 15/SC/ NHS MUSC 4535 (Degenerative Disease of the Hip) 22/10/ /02/ /06/2016 N/A Long negotiations due to protracted discussions over procurement 15/WS/ NHS CANC /01/ /03/2016 N/A Delay receiving pharmacy approval 12/YH/ NHS Epidemiology of AKI in 23/02/ /03/ /04/2016 N/A ICU 15/NW/ NHS CARD 3411 merit-v 18/02/ /03/ /04/2016 N/A 14/SC/ NHS Add-Aspirin Trial 09/12/ /01/ /12/2016 N/A 15/LO/ NHS Effect of Remote Ischaemic Conditioning in PPCI patients (ERIC- PPCI study) 24/11/ /01/ /05/2016 N/A Confusion over whether contract had been signed 15/EM/ NHS RIGHT-2 06/11/ /02/ /03/2016 N/A Discussion over lack of funding for additional scans over and above standard of care 15/EE/ NHS COMPARE ABSORB 29/01/ /02/ /03/2016 N/A 15/LO/ NHS Albumin To prevent Infection in chronic liver failure (ATTIRE) 17/02/ /02/ /07/2016 N/A Site not open to recruitment until 27/06/ /NW/ NHS 2215-CL /01/ /03/ /08/2016 N/A Local review not completed in time. Recruitment rate of 4 ptients over 4 years 15/NE/ NHS Bergamot (GA29144) 01/03/ /03/2016 N/A 4 patietns seen but not elgible, recruitment target of 2 over 3 years
3 Reference of Receipt of of NHS of First 15/NW/ NHS MUK8 - A randomised phase II trial of Cyclophosphamide and Dexamethasone in combination with Ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenolidomide and bortezomib 11/LO/ NHS Minitub (EORTC 1208) - Prospective registry of Sentinel Node (SN) positive melanoma patients with minimal SN tumor burden who undergo Completion Lymph Node Dissection (CLND) or Nodal Observation. 15/LO/ NHS Safetxt: a randomised controlled trial of a safer sex intervention 14/03/ /04/ /05/2016 N/A Delay between final internal approvals and issue R&D approval 08/02/ /04/2016 N/A Delays with recieving radiology approvals, originally declined by radiology due to ultrasound requirements 13/04/ /04/ /06/2016 N/A 14/EM/ NHS Neo-AEGIS - Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (MAGIC regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction. 04/04/ /04/2016 N/A
4 Reference of Receipt of of NHS of First 16/LO/ NHS The?RADIANCE HTN? Study. A study of the ReCor Paradise System in Clinical Hypertension. 15/EM/ NHS Baxalta - A Phase 2a Randomized, Openlabel Study to Assess the Safety, Tolerability, and Efficacy of BAX69 in Combination with 5- FU/Leucovorin or Panitumumab versus Standard of Care in Subjects with Metastatic Colorectal Cancer 15/EM/ NHS TODFU2 - A randomised, double blind, placebo controlled multicenter trial, examining the effect of Natrox? on the rates of healing for chronic diabetic foot ulcers 15/WM/ NHS GAST 4608 (Inflammatory Bowel Disease) 15/WS/ NHS CANC MOR00208C203 15/LO/ NHS Pomalidomide vs bortezomib in MM (CC MM007) 11/03/ /05/ /07/2016 N/A Initial delay in receiving essential documents from study team. Pharmacy involvment was not clear at the beginning of review, additional 2 weeks to gain pharmacy approval. 21/03/ /05/2016 N/A Pharmacy queries addressed by sponsor and Panitumumab and syringe pump to be provided. Study now closed to recruitment 01/04/ /06/ /07/2016 N/A Discussions over status of PI due to extended absence of original PI 23/03/ /04/ /07/2016 N/A although eligible patients were identified their clinic appointments fell outside of the 70 day window. 16/02/ /05/2016 N/A Required to recruit 3 patients over a 3 year period 27/06/ /08/2016 N/A
5 Reference of Receipt of of NHS of First 16/NW/ SAVER 26/10/ /05/ /08/ /07/ /08/ /08/2016 N/A Sponsor delayed site 15/NW/ NHS PARTNER 07/09/ /09/2016 N/A Sponsor delayed site 15/SW/ NHS CANC PREMISE 18/07/ /09/ /11/2016 N/A Study closed by sponosr at all sites. Study closed to recruitment due to studywide target being met. 15/EE/ NHS FOCOS RA Foot Orthoses-Custom v Off the shelf in Rheumatoid Arthritis 14/WS/ NHS Impact of visual impairment after stroke 26/09/ /09/ /11/2016 N/A Sponsor delayed site 14/01/ /01/ /02/2016 N/A 14/LO/ NHS Ripple AT 11/02/ /02/ /05/2016 N/A s screened but no eligible patients identified 15/SC/ NHS The ENCOURAGE Trial 17/06/ /06/ /10/2016 N/A Eligible patients seen chose not to participate in study 13/NI/ MILES? UK Registry for BioMime Sirolimus Eluting Stent System 25/11/ /03/ /05/ /07/ /09/ /09/2016 N/A 01/11/ /LO/ RIPCORD 2 04/11/ /09/ /09/ /08/ /10/ /10/2016 N/A 18/10/ /SC/ TWILIGHT Study 24/11/ /08/ /08/ /07/ /10/ /10/2016 N/A 09/11/ /YH/ ACE-CL /03/ /08/ /08/ /09/ /09/2016 N/A 04/10/ /SC/ A Randomized Ph. 2/3 Study of DACOGENr & JNJ vs DACOGENr alone 29/07/ /07/ /09/ /11/ /11/2016 N/A 02/11/ /LO/ PenelopeB 20/11/ /05/ /06/ /11/ /11/2016 N/A 16/01/ /LO/ PRISM 10/10/ /10/ /06/ /12/ /12/2016 N/A 15/12/ /YH/ CANC /08/ /08/ /09/ /12/ /12/2016 N/A 16/12/2016
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
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
Studies proceeding under pre HRA-Approval system (NHS Permission)
15/NW/0004 162679 Studies proceeding under pre HRA-roval system (NHS Permission) A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST- LINE METASTATIC COLORECTAL
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?
Date of HRA. Date Site Invited. Date Site Selected. Approval. Recruited. Date
14/LO/0259 134883 RE-AKT: A randomised Phase II study of enzalutamide (MDV3100) in combination with AZD5363 in s with Metastatic Castration - Resistant Prostate Cancer Yes 08/01/2018 01/07/2016 01/07/2017
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
Performance in Initiating Clinical Research Q4 2015/16
Performance in Initiating Clinical Research Q4 2015/16 Research Ethics Committee Reference Number Integrated Research Application System Number Name of Trial Date of Receipt of Valid Research Application
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
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
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
Table 1 Salford Royal NHS Foundation Trust: Performance in initiating clinical research (HRA Approval) Reporting period 1 April March 2017
Table 1 Salford Royal NHS Foundation Trust: Performance in initiating clinical research (HRA Approval) Reporting period 1 April 2016 31 March 2017 REC reference IRAS number Study title 16/NW/0428 207062
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?
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HRA Approval Date Site Date Site Sponsor. Non- Confirmation Status. Date Site Ready To Start
Research Ethics Committee Reference Number Integrated Research Application System Number Submission Type Name of Trial Date of Receipt of Date of Valid Research Application First Patient Recruited? Date
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
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
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
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
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