Privacy Notice
Consent is an important part of the research process and is frequently sought for participation in research studies. In most instances we will rely on Article 6(1)e and Article 9(2)j of the UK GDPR if and when we use your information for research. If you have formally consented to take part in research, this will satisfy the common law duty of confidentiality and you will be told how information about you will be used. Where it has been impracticable to obtain your consent we will seek approval from the Secretary of State via the Confidentiality Advisory Group under Section 251 of the National Health Service Act 2006. For further information on this legislation please visit the Government's UK legislation Website.
You have a choice about whether you want your confidential patient information to be used in this way. If you are happy with this use of information you do not need to do anything. If you do choose to opt-out your confidential patient information will still be used to support your individual care. To find out more or to register your choice to opt out, please visit www.nhs.uk/your-nhs-data-matters.
The guidance below outlines the relevant time frame patient records should be retained if they have participated in a clinical trial.
The rationale for retaining patient records for an appropriate period is to allow further analysis and safety monitoring by regulatory authorities as necessary.
The Medical Research Council (MRC) has set out guidance for the time frame of the retention of medical notes below:
- For basic research –research data and data material should be retained for 5 years after the completion of the trial.
- For population health and clinical studies, the records and research data should be retained for 20 years after the study has been completed.
- Studies that require records to be retained for more than 20 years must have a valid justification.
- In some cases, the sponsor of the clinical trial may have set guidance for a specific retention time which differs from the MRC. In such cases the sponsor guidance should be followed.
In order to identify patient records that must be retained in this way a yellow alert sticker is placed on the red alert page in the inside of a patients’ notes.
If there is any doubt or concern over how long an individual patient’s record should be stored please contact the Head of Research and Innovation.
Here is a link to their Privacy Notice.