Title: How to set up interventional and/or invasive clinical studies not involving investigational medicinal products in the NHS
Speakers: Fiona Smith
Abstract:

Ever wondered how the anonymised healthcare data sets required for machine learning research come to exist and what approvals are needed before you can start looking at the data and doing the analysis? This talk will give a brief overview of the steps involved in setting up a clinical study in the NHS that does not involve an investigational medicinal product (Non-CTIMPs). It is informed by my experience of setting up a Non-CTIMP that covers more than one NHS health board. Expect an overview of the role of The Academic and Clinical Central Office for Research and Development (ACCORD) in setting up NHS Lothian/University of Edinburgh research projects, the School of Informatics Ethics Approval process, and what is involved in writing project protocols, patient information sheets, patient consent forms, data management plans and securing data sharing agreements.