Research Project Management on Clinical Trials-1

Abstract

The scenario of this project came from amalgamation of both good clinical practice (GCP) the project management for professional (PMP); since all research studies and clinical trials are considered as research project then we have to prepare and formulate a “Research Manager” for research projects with specific job description for what are the steps to follow to get a successful and completed clinical trials. In-fact, writing this book depends on two main references articles namely: “A guide to the project management body of knowledge: (PMBOK guide)” project management for professional and “Clinical Trials Requirement Guideline (version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.