Contents include:8 role and responsibilities of the sponsor8 how to take a proportionate approach to trial management, including risk assessment8 regulatory and ethical considerations8 pha
management of investigationa
data management and statistics activities8 roles and responsi
The Go
Foreword ix01 Acknowledgements xi01 Feedback xii01 Abbreviations xiii01 Preface xvii01 Introduction xx11 Chapter 1 Sponsor oversight 112 1.1 Sponsors 312 1.2 Clinical trial