Clinical Trial Protocol Development

Every clinical research investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial) and ensures the safety of the trial subjects
and integrity of the data collected.

Contents

The Clinical trial protocol development short course provides students the knowledge and skills essential to writing and developing clinical research protocols that follow regulatory requirements.

You will learn the fundamental components of the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project that make up a clinical trial protocol.