This is an optional template email for sponsors to share category A or B amendment documents with sites where regulatory approvals are outstanding. You can use this template to notify participating NHS organisations in England and Wales that are affected by a Category A or B 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 A and B amendments, and is intended to be sent as soon as the email confirming online submission of the amendment is received the person submitting the amendment.
In England and Wales, the 35 calendar day clock starts from the date that participating organisations (NHS R&D Office, LCRN (where applicable) as well as the local research team) are notified of the amendment by 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 insert option A or B
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 for the above referenced study. Attached is the confirmation of submission email together with the amendment package. Please read the documents and amendment tool carefully as these provide information on how this amendment should be implemented, as well as what the amendment entails.
When will this amendment be implemented?
The completed amendment tool has categorised this amendment as category (insert) A or B. In line with the UK wide policy on the handling of amendments, your site has 35 calendar days from the date of this notification to raise an objection about the amendment. If we do not hear from you by (insert) date, we will assume that the amendment may be implemented at your site, once regulatory approvals are in place. If you need more time to consider the amendment please contact us prior to the 35 day deadline and we will assist with any queries you may have. If you are able to notify us ahead of this date that you are able to accommodate this amendment it will enable us to potentially implement sooner.
What is the impact on research activities at sites?
(Insert if no impact on research activities.) This amendment does not impact the research activities undertaken at participating NHS organisations.
(Insert if there is an impact on the research activities.) This amendment impacts the research activities undertaken at NHS organisations. The main changes for attention are user to summarise the important changes to research activities that NHS organisations may need to consider, for example changes in procedures, patient visits, additional tests, changes affecting support departments (list not exhaustive).
Is there any impact on funding/agreements?
(Insert if no impact on funding and/or agreements.) This amendment does not impact the funding/agreement that have previously been agreed.
(Insert if there is an impact on funding/agreement.) This amendment impacts the funding/agreement that have previously been agreed. (User to provide information on the changes, and how these are to be discussed/agreed.)
What is the HRA & HCRW Approval status of the amendment?
Please note that this amendment is currently outstanding regulatory approvals. These documents are being provided to you for your information and review at this stage; they should NOT be implemented until all approvals are received. We will further inform you when HRA and HCRW Approval for the amendment is issued, and it can be implemented.
If you need to discuss the impact of the amendment at your site please do not hesitate to contact me.
Kind regards,
(Insert) Sponsor (or representative of)