PLEASE NOTE: This course has had a change of code - up to and including 2009 it was PHPH9120.

This course provides an introduction to clinical project and clinical trial management, and interpreting the clinical literature. The course starts with a brief introduction to the regulatory requirements applicable for clinical development in Australia with reference to the relevant requirements of the US and European authorities. Clinical trials management reviews all stages involved in conducting a clinical trial. The stages covered include the initial project proposal; development of the protocol and other trial related documentation required to gain ethical and regulatory approval for a clinical trial; planning of all trial related materials required to commence the study; conduct of the trial during patient recruitment and treatment; data management and analysis of the data generated from the study; reporting of the data and finally “close-out” of the trial. Responsibilities of the sponsor in trial planning, approval, investigator selection, monitoring and auditing are discussed. The International Conference on Harmonisation (ICH) code of Good Clinical Practice (GCP) is emphasised throughout the module. The last chapter of the course will provide the essential knowledge, tools and practice to critically assess clinical research literature.

The course is compulsory for program 7370, 5504, and 9060.