The focus of the advanced module will be the practical application of the underlying principles encountered in the core course on clinical trials management. Students will prepare a complete data package for the research ethics committee (REC) for a study submitted as part of the clinical trials notification (CTN) scheme as the major focus and assessment task for this module. The trial will be multi-centred and early phase, that is Phase II to III. There will be potential serious toxicities and a data safety monitoring committee will need to be established. Students will develop the clinical trials protocol, the draft patient consent form, and case report form (CRF). The application package will be assessed by a mock REC and the student will be asked to respond to questions and criticisms raised by the REC.