Scotland is a global centre of excellence for clinical research supporting research studies from all life science sectors including pharmaceutical, biotechnology and medical technology companies.

It is important to consider at an early stage the evidence base required for your product to enable use in clinical practice.

The team at SHIL can support this activity and work closely with NHS Research Scotland – a partnership of Scottish NHS Boards and the Chief Scientist Office (CSO) of Scottish Government who are responsible for the management and delivery of clinical research across NHS Scotland.

Things to consider are:

• Research can vary from a questionnaire or audit through to a full randomised controlled trial (RCT)
• Resources on the HRA website will help you determine which category your product or service falls into.
• The type of research will determine the approval process and timelines
• Your local research and development (R&D) office will also be able to give advice on whether the project is research and requires management within the Research Governance Framework for Health and Social Care. They will also confirm if ethical review by a REC is required and advise on local governance procedures for other types of projects such as an audit or service evaluation.