Appendix 1: Details of applications reviewed. Applications reviewed by full committee Date Provisional Co-ordinating Application Date of first Date of final reference status Short title application response investigator type decision decision validated received A Study of RG1662 in Adults 14/NTA/10 Decline and Adolescents with Down Prof Ed Mitchell Intervention 30/01/2014 15/04/2014 syndrome (CLEMATIS) 14/NTA/11 Approve IFOOD Mrs Katrina Pace Intervention 30/01/2014 18/02/2014 IBS Discomfort Elimination 14/NTA/12 Approve Dr Alasdair Patrick Intervention 30/01/2014 18/02/2014 Assessment (IDEA) Study Mrs Emma (Ema) 14/NTA/13 Approve Wellbeing trial for children Intervention 30/01/2014 18/02/2014 Tokolahi Alios BioPharma Dr. Thorsten 14/NTA/16 Decline Intervention 30/01/2014 18/02/2014 Stanley Endometrial Carcinoma A – 14/NTA/4 Approve Retrospective Study at a Dr Trial Bigby Observational 30/01/2014 18/02/2014 Single Community Hospital Reduced-dose rivaroxaban in the long-term prevention of 14/NTA/7 Approve Dr Mark Smith Intervention 30/01/2014 18/02/2014 recurrent symptomatic venous thromboembolism (VTE) Dr Andrew G. 14/NTA/22 Approve PHYSACTO™ Intervention 27/02/2014 17/03/2014 Veale Associate 14/NTA/25 Approve TOBA - BTK Professor Andrew Intervention 27/02/2014 17/03/2014 Holden Safety and Performance Associate 14/NTA/26 Approve Study of the Shockwave Professor Andrew Intervention 27/02/2014 17/03/2014 Lithoplasty System Holden ASPECT - A double-blind study to assess the safety and efficacy of intravenous Dr Shay Approve Ceftolozane/Tazobactam with Intervention 27/02/2014 15/04/2014 8/07/2014 22/07/2014 14/NTA/31 McGuinness that of Meropenem in Ventilated Nosocomial Pneumonia 14/NTA/32 Approve LEE011X2106 Dr Rita Sasidharan Intervention 27/02/2014 17/03/2014 22/05/2014 21/07/2014
Appendix 1: Details of applications reviewed. Applications reviewed by full committee reference status Short title Co-ordinating investigator Application type Date application validated Date of first decision Provisional response received Date of final decision 14/NTA/10 Decline A Study of RG1662 in Adults and Adolescents with Down syndrome (CLEMATIS) Prof Ed Mitchell Intervention 30/01/2014 15/04/2014 14/NTA/11 Approve IFOOD Mrs Katrina Pace Intervention 30/01/2014 18/02/2014 14/NTA/12 Approve IBS Discomfort Elimination Assessment (IDEA) Study Dr Alasdair Patrick Intervention 30/01/2014 18/02/2014 14/NTA/13 Approve Wellbeing for children Mrs Emma (Ema) Tokolahi Intervention 30/01/2014 18/02/2014 14/NTA/16 Decline Alios BioPharma Dr. Thorsten Stanley Intervention 30/01/2014 18/02/2014 14/NTA/4 Approve Endometrial Carcinoma – A Retrospective Study at a Single Community Hospital Dr Bigby Observational 30/01/2014 18/02/2014 14/NTA/7 Approve Reduced-dose rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) Dr Mark Smith Intervention 30/01/2014 18/02/2014 14/NTA/22 Approve PHYSACTO™ Dr Andrew G. Veale Intervention 27/02/2014 17/03/2014 14/NTA/25 Approve TOBA - BTK Associate Professor Andrew Holden Intervention 27/02/2014 17/03/2014 14/NTA/26 Approve Safety and Performance Study of the Shockwave Lithoplasty System Associate Professor Andrew Holden Intervention 27/02/2014 17/03/2014 14/NTA/31 Approve ASPECT - A double-blind study to assess the safety and efficacy of intravenous Ceftolozane/Tazobactam with that of Meropenem in Ventilated Nosocomial Pneumonia Dr Shay McGuinness Intervention 27/02/2014 15/04/2014 8/07/2014 22/07/2014 14/NTA/32 Approve LEE011X2106 Dr Rita Sasidharan Intervention 27/02/2014 17/03/2014 22/05/2014 21/07/2014 trial Trial
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