How are Electronic Patient Notes Accessed in Clinical Trials?

The Medicines and Healthcare products Regulatory Agency (MHRA), the agency responsible for ensuring that medicines work and are safe, is organising a online meeting on Wednesday 31 March from 10:00 – 11:30am to ask patients and patients representatives about a new guidance for accessing electronic patient notes in clinical trials.

Have your say on a guidance on electronic patient notes

They have said to us:

This is a follow up meeting from the one that took place on 5th February to discuss initial views on this topic. Following on from the comments we had at this meeting and subsequent discussion with other stakeholders (including the NHS clinical research community, the Health Research Authority, pharmaceutical companies and those who sell medical records software) the first draft of the guidance has now been developed.

This guidance will also cover topics such as consent, confidentiality, and security and we will be asking for your views at the next meeting. 

We would like to gather a wide range of views from patient representatives and patients on this first draft of guidance. We welcome your attendance even if you were unable to attend the first meeting as there will be a summary of the points previously made.

We are currently finalising some slides which we will present at the meeting. These will be provided to you prior to the meeting. We hope to then discuss your opinions on the draft guidance and whether you feel there are other areas that should be considered.

If you would like to attend the meeting please email by Friday 26th March. We will then provide you with the slides, agenda and joining instructions. 

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