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Nice Data Collection Agreement

4.4 In addition, Vertex retains all rights and scope for commercial and legal appreciation in the management of its activities, which are contained in secondary sources, including protocol definition, study management, data collection and transfer, and intellectual property rights. By the agreement to provide data from secondary sources, Vertex does not waive its rights to secondary sources that are part of Vertex`s normal activity outside of this agreement, nor to its decision-making power. For example, if Vertex agrees to provide information on a clinical trial, Vertex does not undertake to conduct or manage such a study in any way, and NICE and NHSE-I are not authorized to determine the parameters of the clinical trial, clinical trial or other data production program or vertex management of their external providers. This agreement deals with the treatment of cystic fibrosis patients with: 4.3 Secondary sources listed in Table 1 are owned and managed by Vertex, but shared with the Interim Tender Committee in accordance with point 11.1 for monitoring and awareness by the Interim Access Tender Committee and facilitating the provision of discretionary advice on data collection procedures. Data from secondary sources shared by Vertex under this contract is not subject to direct control of NICE, NHSE-I or the Interim Access Committee, confidentiality rules, intellectual property rights and Vertex`s privacy policy and secondary sources. Vertex will conduct a study in the UK to collect quality of life (LQ) data on patients and nurses. The Cystic Fibrosis Questionnaire – Revised (CFQ-R) is used to collect QoL data in patients. QoL`s generic tools are used as needed to collect data from managers. The results will be available prior to the proposals for evaluation of health technologies at NICE and shared with NICE as a scientific commission. Vertex: 1.2 The objective of this agreement is to describe the precautions to be taken to establish data that could correct clinical uncertainties in the lumacaftor/ivacaftor database, tezacaftor/ivacaftor and ivacaftor and ivacaftor and ivacaftor/tezacaftor/elexacaftor to enable future evaluation of health technology by NICE. The clinical uncertainties of 3.1 were identified by NICE`s TECHNOLOGIQUE evaluation committee and in consultation with clinical experts in cystic fibrosis and the NICE External Assessment Centre. Ideally, the data should be collected in the UK fibrosis registry according to the recommended frequency below.

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