During an inspection

When the Inspection starts

Here are some tips and hints about what to do during an Inspection. You can find a full set of Frequently Asked Questions about the whole inspection process in the For Research Staff area of the NUH website.

The MHRA Inspection team are all professionals in their own fields and will have knowledge and experience of research from a range of perspectives. They share the same aims as we do – to ensure that the research we carry out is of the highest quality, meets all legal and regulatory requirements and is contributing meaningful outcomes/data to help patients.

They are also visitors to NUH and we should welcome them and work with them in a positive and co-operative way at all times.

If you are asked questions by a member of the Inspection team, then please remember:

  • It’s OK to say you don’t know the answer to a question you are asked: don’t be tempted to guess or speculate.
  • Be honest: volunteer any issues that you know about at the start of the inspection to show them that you dealing with the issue(s) proactively.
  • Do not be tempted to replace missing records; if any of your records are missing, explain why they are missing and record this on a File note
  • Explain your role and duties clearly: it might help to refresh yourself on your job description, on Good Clinical Practice, and any changes in role or work that have been introduced
  • Make sure all of your training is documented and your file is up to date: it is very likely that the Inspectors will ask about your role and what training you have undertaken, and how you keep up to date.
  • Only sign SOPs relevant to your role
  • Be concise and to the point: the Inspectors only have a limited time in each area/on each trial, so it will help everything run to smoothly if you concentrate on answering the questions they ask, rather than giving a lot of other information. They can always ask you for more information if they need it.

You can find more information on the MHRA Inspection here: https://www.nuh.nhs.uk/mhra2023