This is an optional email for sponsors to use to notify the local research teams at participating NHS/HSC organisations of a GDPR amendment.
This
template should only be used to notify research teams of non-substantial,
non-notifiable amendments made in relation to the published GDPR guidance for research in
the NHS/HSC (link to guidance).
Where the above guidance has been followed, the R&D office of participating NHS/HSC organisations does not need to be notified of this amendment, nor do national coordinating functions
Any other amendments not in accordance with the above GDPR guidance for research in the NHS/HSC should be submitted to the lead nation and implemented through the normal amendment process.
Replace text in square brackets [ ] as appropriate.
Template email
From: Sponsor (or delegate)
To: local research team at participating NHS/HSC organisations
Subject: [IRAS Number]: Notification of GDPR Amendment
Attachments: All amended documents
Body of Text:
Dear participating organisation/s,
RE: [IRAS Number; Short Study Title; Amendment Reference]
Please find attached documents for the above study that have been amended as a result of the new GDPR regulations.
Who should be notified of this amendment?
In line with the GDPR guidance for research in the NHS/HSC, we are providing this amendment to you, as a member of the local research team of a participating NHS/HSC organisation. In line with the guidance, this amendment will not be sent separately to the local R&D office, nor to any coordinating functions of participating nations.
The above guidance also confirms that no approvals are needed to implement this amendment.
When should I implement this amendment?
In light of the above, this amendment should be implemented [immediately/ on dd/mm/yyyy] at participating NHS/HSC organisations, without the need for any local R&D office confirmation.
How should I implement the amendment?
[Sponsor (or delegate) to add a summary of how this amendment should be implemented. Please provide clear information on what documents should be provided to whom, and what information should be displayed or disseminated.]
Please do contact me if you have any questions about the implementation of this amendment.
Kind regards
[Sponsor (or representative of)]