【产品手册】诺华制药Novartis_业务宣传册Brochure_Investigator_awar.docxVIP

IITInvestigator Awareness Brochure IIT Investigator Awareness Brochure Contents TOC \o 1-1 \h \z \u Introduction 4 Requirements (feasibility) to conduct a clinical study 5 IIT application process 6 Overview of the IIT process 7 Safety reporting requirements 10 Study results and publications 13 Key responsibilities of Novartis and the Investigator 14 Abbreviations 15 IIT Investigator Awareness 3 Introduction As part of the commitment by Novartis to deliver innovative therapies to patients worldwide, Novartis believes in the need to support ethical independent clinical research conducted by qualified third-party sponsors (Investigators). The value of this scientific research, together with Novartis-sponsored research, is fundamental to the understanding of the benefit/risk profile of Novartis therapies and the exploration of new opportunities to address unmet medical needs. This is why Novartis provides support to new Investigator Initiated Trials (IITs) every year. An IIT is defined as a study with scientific and medical merit developed and sponsored by an independent Investigator or academic sponsor. An IIT may be a clinical or non-clinical study conducted without the participation of Novartis, for which the IIT sponsor requests Novartis to provide either funding, drug product or both. As an Investigator, if your IIT proposal is accepted, Novartis may provide you with financial support and/or Novartis product(s). However, you will retain full responsibility and control of the design, initiation, management, data analysis, monitoring, and reporting, as the sponsor of the study. Please note that for Non-Interventional Studies, Novartis is only able to provide financial support, not study drug. The purpose of this brochure is to provide a clear description of each of the essential requirements that must be fulfilled before support will be considered by Novartis, and to highlight your obligations as the study sponsor when your IIT is being supported