Data Protection and Privacy Information
1.Introduction
You can read the MHRA Privacy Notice to find out in general terms the types of personal data we process and why; as well as information about your rights and how to raise concerns.
This information notice sets out the approach to the Draft Clinical Trials Regulations Guidance review survey that the MHRA will take to handle information appropriately and to comply with data protection legislation.
This information notice covers documents gathered and created during this Draft Clinical Trials Regulations Guidance review survey and anything in which information of any description is recorded, whether in paper or electronic form.
2. Legal requirements for information management and privacy
The Draft Clinical Trials Regulations Guidance review survey complies with data protection legislation including the Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR).
3. Lawful basis and purpose of processing personal information
The Draft Clinical Trials Regulations Guidance review survey will collect and use personal information for the purpose of gathering feedback on the guidance.
We rely on UK GDPR Article 6(1)(consent) as our legal basis for processing your personal data.
Individuals whose personal information is held by the MHRA for purposes of the Draft Clinical Trials Regulations Guidance review survey will have their information used to gather feedback on the guidance. In the case of personal information, the purpose is to use demographic information to help us contact those respondents by email.
4. Security and confidentiality
The MHRA Marketing team and the Clinical Investigations and Trials team will access the data.
Those who do are aware of their obligations and responsibilities when handling personal and confidential information. They are subject to employment, contractual and other professional obligations regarding confidential and official information, both during the Draft Clinical Trials Regulations Guidance review survey and afterwards.
The information that you enter will be held on a secure shared digital platform.
All personal and confidential information is stored securely to prevent loss or inappropriate access.
5. Sharing information
The MHRA will hold the personal information you provide in this form and use it for the purpose of collecting demographic information to help us contact you with further information.
If any new partner is identified, we will contact yourself to inform you of this and check that you are happy for information to be shared with them.
We do not intend to share your personal data with any other third party other than our data processors who act only upon our instructions. We will handle any specific requests from a third party for us to share your personal data with them in accordance with data protection law. We will not sell your personal data.
Information from the Draft Clinical Trials Regulations Guidance review survey including personal information, may be disclosed in accordance with the access to information regimes. These are primarily the Freedom of Information Act 2000 (FOIA), the Data Protection Act 2018 (DPA), the UK General Data Protection Regulation 2016 (GDPR) and the Environmental Information Regulations 2004.
The MHRA will process your personal data in accordance with the DPA and UK GDPR and in most circumstances, this will mean that your personal data will not be disclosed to third parties.
6. Retention and destruction of documents
We will retain your data for up to 18 months.
7. Rights
You have several rights which are outlined in the MHRA Privacy Notice: https://www.gov.uk/government/publications/mhra-privacy-notice. For greater detail on when they apply please refer to the Information Commissioner’s website If you wish to exercise any of your rights, or have any questions or concerns, please contact our Data Protection Officer at dataprotection@mhra.gov.uk.