title: Randomized controlled trials: planning, monitoring, and execution.
abstract: Large integrated multidisciplinary teams have become recognized as an efficient means by which to drive innovation and discovery in clinical research. This chapter describes how to plan, budget and fund these large studies and execute the studies with well-designed governance and monitoring protocols in place, to efficiently manage the large, often dispersed teams involved. Sources of funding are identified, budget development, justification, reporting, financial governance and accountability are described, in addition to the creation and management of the multidisciplinary team that will implement the research plan.
authors.affiliation: Clinical Epidemiology, Faculty of Medicine, Memorial University of Newfoundland, Room 3M102A 300 Prince Phillip Drive Health Sciences Centre, St. John's, NL, Canada, A1B 3V6.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hatfield
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Dicks
authors.forename: Patrick S
authors.initials: PS
authors.lastname: Parfrey
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000941:ethics / Q000379:methods; D005378:Financial Support; D005380:Financing, Government; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000941:ethics / Q000379:methods*; D012941:Social Responsibility