5 Steps to Implement Regulatory Changes

There’s quite a bit of change going on in the world of clinical research and it can be a challenge keeping clinical trial practice up to date. So when it comes to implementing changes where do you start? Here are 5 steps which I think will help to break it down.


1. Know what the changes are.

It’s important to have some kind of regulatory intelligence process so that you know when new legislation and guidance is introduced. You can use vendors to do this or you can just assign someone to trawl the internet regularly, which is what I do. You can also sign up to update bulletins from the regulators and also my newsletter, where I provide the current information I’m aware of approximately once a month. Click here to be added to my mailing list.

2. Perform a Gap Analysis.

By this I mean that you need someone to read the guidance or legislation (there’s really no way to avoid this!), identify those requirements which are new and compare against your current processes and procedures. This way you can identify the changes that are needed and also prioritise the most important ones.

3. Make an action plan.

Once you know what changes you need to make you can plan how to do this. In making the plan you need to think about the processes and procedures which need to change, what resource will be needed, allocation of responsibilities and accountabilities, timelines and deadlines, communication and training strategy and finally review of effectiveness.

4. Implement the action plan.

Sounds simple, but of course it’s not! The key to making this happen is having buy in and support from Senior Management to drive the change, empower those with operational responsibility and recognise and reward progress. Day to day priorities always threaten change management activities, but with these changes sooner is better to avoid inspection findings further down the line, so the allocation of resource is particularly important to make sure you can get it done.

5. Review.

This should really be an integral part of implementing the action plan, but it’s so important I decided it should have its own heading! Once the action has been taken it’s vital to check that you have covered everything, and that all those affected are clear on what the changes are and comfortable with implementing new and updated processes and procedures. Then reflect on what you’ve learned. What worked well, what could be improved next time and how can you reward and celebrate the achievements.


I’m not trying to say this process is easy or simple, but it is very important, and breaking it down hopefully make it seem less daunting. And, of course, if I can help in any way with advice or training, you know where to find me!


Oh, and by the way, it shouldn’t need saying, but don’t forget to DOCUMENT EVERYTHING!

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