This is an optional email template for sponsors to use to notify participating NHS organisations in England and Wales that an amendment can be implemented. The notification should be sent to both the research management office and local research team, as well as the LCRN (Local Clinical Research Networks) for studies included on the NIHR (National Institute for Health Research) portfolio.
For category A and B amendments
This should be sent once all regulatory approvals are in place and HRA and HCRW Approval for the amendment has been issued, and when the 35 calendar time limit has passed. This may be used ahead of the 35 calendar time limit if (a) HRA and HCRW Approval for the amendment has been issued and (b) the site has confirmed it can implement the amendment.
For category C amendments
This should be sent once all regulatory approvals are in place and HRA and HCRW Approval for the amendment has been issued. Where HRA and HCRW Approval for the amendment was confirmed in the confirmation of submission email, the sponsor should send the 'Template email for sponsors to share category C amendment documents with sites' only.
The use of this template email will ensure clear and consistent communication between the sponsor and participating NHS organisations in England and Wales about implementation of amendments, and is intended to be sent as soon as the amendment can be implemented.
Text that is highlighted in red should be amended by the sponsor as appropriate prior to issue of the email.
Please amend the text as appropriate where text is highlighted in bold (and instructions are given in brackets) prior to sending your email.
Template
From: Sponsor (or insert representative)
To: Site research management function and local research team and, where applicable LCRN, (this template can be used to email multiple sites in one email, or one site individually).
Subject: (Insert) IRAS Number; Implementation of Amendment
Attachments:
Confirmation of submission email, amendment package (including all amended documents, locked pdf of the amendment tool and REC opinion, if applicable and already issued); HRA and HCRW Approval outcome email for the amendment
Body of Text:
Dear participating organisation/s, (name if sending to one site),
RE: (Insert) IRAS Number; Short Study Title; Amendment Reference
Further to my previous email, I can now confirm that all approvals, including HRA & HCRW Approval, for this amendment have been issued. As such, the amendment can now be implemented at your site.
What are the approved documents?
| Document | Version number | Date |
| (Insert document name) | (Insert version number) | (Add date) |
| (Insert document name) | (Insert version number) | (Add date) |
Option 1
(Add if no changes to documents during regulatory review.)
Please note there were no changes to the documents as a result of the regulatory review(s).
Option 2
(Add if documents were changes during regulatory review.)
Please note there were changes to the submitted document set as a result of regulatory review(s).
The potential impacts of this amendment to research sites were outlined in the initial document set provided to you with the amendment tool. If you need to discuss this amendment further please do not hesitate to contact me
Kind regards
(Insert) Sponsor (or representative of)