Skip to content
left end
left end
right end

Submitting amendments

For single site/UH Bristol led studies:

If you wish to make an amendment to your study, you will need to:

  • Contact the Sponsor to ensure they give approval of the proposed amendment. If the Sponsor is UH Bristol please email researchapprovals@uhbristol.nhs.uk with the proposed amended paperwork
  • Discuss with the Sponsor whether the amendment is considered 'substantial' or 'non-substantial'

Ultimately it is the responsibility of the Sponsor to decide whether an amendment is substantial or not. Please find below a link to examples of both types of amendments from the HRA website for guidance:

http://www.hra.nhs.uk/research-community/during-your-research-project/amendments/definitions-of-substantial-and-non-substantial-amendments/ 

Once a Sponsor has approved the proposed amendment the relevant paperwork will need to be submitted to each regulatory authority. Information on what you need to do can be found on the IRAS system. Once you are in your project on IRAS click onto the applicable forms on the left (REC, R&D, MHRA etc) and tabs will appear across your screen. One of these is entitled "Amendments" and gives details on what you need to do to submit as well as providing the links to the relevant forms to complete.

Submitting amendments to the REC, MHRA and relevant R&D office can all be done in parallel. For UH Bristol led multicentre studies it is important to note that the R&D offices at participating sites will need to be notified of all amendments in case there are any resource/logistical implications associated with it.

If your study is on the NIHR portfolio, amendments can be processed through the Centralised System for gaining NHS Permission (CSP). IRAS will provide more information on the relevant submission process for this. What this does mean however is that for multicentre trials you will be able to submit the paperwork through a single entry point which will then be disseminated to all site R&D offices.

Unfortunately if your study is not on the NIHR portfolio you will need to submit your amendments to each R&D office individually.

For studies where UH Bristol is a participating site only

Amendments will ordinarily be generated by the Sponsor/lead site. They should then contact their participating sites to notify the research teams of the amendment well in advance of the paperwork being submitted. This allows for sites to look at how the amendment impacts on them locally and whether any resources/feasibility need to be re-reviewed. Sites can also reject the amendment if they are unable to implement it at their site. As soon as you are notified of an amendment please send a copy to researchapprovals@uhbristol.nhs.uk if you have had no other correspondence to indicate that R&I have received the amendment from another source.  We will then issue an acknowledgement letter of the proposed amendment. A copy of this will be saved onto the project record on EDGE.

If a local amendment needs to be made please ensure this is discussed with the Sponsor and lead site who will produce the paperwork needed to submit the amendment. Please also ensure that a copy of the amendment is sent to researchapprovals@uhbristol.nhs.uk

What if the amendment is Non-Substantial?

It is not mandatory to notify the Research Ethics Committee, MHRA or R&D offices of non-substantial amendments. These can be sent to each authority for information only.

More information on the notification processes can be found on the HRA website.