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The aim of this module is to teach the practical knowledge required for undertaking preclinical and clinical research. For understanding preclinical research, the module will cover a range of topics including research ethics, critical appraisal of manuscripts and the process of grant applications. For the clinical studies, the module will teach a range of relevant areas, including Clinical Governance, Clinical Trial Processes, Data Management and Pharmacovigilance.

Students will acquire a thorough grounding in the methods required to design and implement a research project from conception to end of study, including how to prepare study documentation, obtain ethical and regulatory approvals, and apply for sponsorship. The module will also cover the main principles of:

• The regulatory framework overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA), focussing on Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Bio-banking and the Human Tissue Act
• Critical appraisal of papers and systematic evaluation of published research

The module will employ varied teaching approaches. Lectures will be complemented by practical classes on reviewing a series of papers, writing abstracts and preparing posters. Specifically, students will learn how to carry out descriptive data analysis and carry out and interpret hypothesis tests.

The students will have acquired the knowledge required to undertake clinical and preclinical research. This will include gaining an understanding of the various legal and ethical requirements, as well as the processes involved in study applications. They will also be able to critically appraise research studies, whether as published papers and/or grant applications.

The module will be assessed by an unseen written exam (abstract writing), and a poster presentation.