This is an optional email template for sponsors to use to notify participating NHS organisations in England and Wales of a Category C amendment.
The notification should be sent to both the research management office and local research team. For NHS/HSC organisations in Northern Ireland and Scotland, the national coordinating function will share documents with the R&D offices of their sites directly, and there is no need for the sponsor to separately notify NHS/HSC R&D offices in Scotland and Northern Ireland.
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 Category C amendments, and is intended to be sent as soon as the confirmation of submission email, is issued to the sponsor.
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: (Insert) Sponsor or 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; Notification of Amendment. Category C
Attachments: Confirmation of submission email, amendment package (including all amended documents, locked pdf of the amendment tool and Research Ethics Committee (REC) opinion, if applicable and already issued).
Body of Text
Dear participating organisation/s, (name if sending to one site),
RE: (Insert) IRAS Number; Short Study Title; Amendment Reference
We have submitted an amendment via IRAS for the above referenced study. Attached is the HRA categorisation email together with the amendment package. Please read the documents carefully.
What does the amendment relate to?
(User to add a brief summary of the amendment and any changes to sites e.g. new version of participant information sheet for use)
Option 1
(Send if the submission email confirms it is a non- substantial no study wide require required.)
When will this amendment be implemented?
This amendment has been categorised as category C,. In line with the UK wide policy on the handling of amendments, the amendment tool has confirmed that:
- this amendment does not impact participating NHS organisations
- this amendment is a non- substantial amendment and does not require study wide review or HRA & HCRW Approval
As such, this amendment will be implemented immediately.
What are the approved documents?
| Document | Version | Date |
| (Insert document name) | (Insert version number) | (Add date) |
| (Insert document name) | (Insert version number) | (Add date) |
If you need to discuss this amendment please do not hesitate to contact me.
Option 2
(Send if the amendment tool indicates that HRA and HCRW Approval for the amendment is pending)
When will this amendment be implemented?
This amendment has been categorised as category C. In line with the UK wide policy on the handling of amendments, the amendment tool has confirmed that:
- this amendment does not impact participating NHS organisations
- HRA and HCRW Approval for the amendment form is pending
As such, this amendment should NOT be implemented at participating organisations in England or Wales. We will further inform you once HRA and HCRW Approval has been given for this amendment, and when it can be implemented. If you need to discuss this amendment please do not hesitate to contact me
End of options
Kind regards
(Insert) Sponsor (or representative of)