The commercial model agreements for use with participating NHS and HSC organisations have been updated to align with the model Commercial Chief Investigator Agreements published in June 2025.
On Wednesday 30 July we issued a HRA Now email explaining what commercial sponsors, contract research organisations (CROs), NHS and HSC organisations need to be aware of.
Which commercial model agreements have been updated?
The following suite of commercial model agreements for use with participating NHS and HSC organisations has been updated:
- model Clinical Trial Agreements (mCTAs) including:
- the Primary Care mCTAs (PC-mCTAs)
- the Advanced Therapy Medicinal Product mCTAs (ATMP-mCTAs)
- model Clinical Investigation Agreements (mCIAs)
- model Non-Interventional Study Agreements (mNISAs)
- model Commercial Participant Identification Agreement (mC-PICA)
- model Commercial Hub and Spoke Agreement
- model Confidential Disclosure Agreements (mCDAs)
You can download these model agreements on IRAS Help.
What is changing?
The definitions of ‘Agent’ and ‘Confidential Information’ in all of these agreements have been updated to align with the recent changes made to the model Commercial Chief Investigator Agreements (mCCIAs).
Confidential information can now be shared by the chief investigator with potential and participating NHS and HSC organisations. We have clarified that another party, such as a CRO, can sign the agreement on behalf of the sponsor – not just an affiliate.
Corrections have also been made after feedback was received on the previous versions.
We recommend that sponsors use the July 2025 versions of these agreements in their IRAS submissions as soon as possible. The July 2025 versions of the agreements will only be accepted in new IRAS submissions from 1 October 2025.
The May 2025 versions of the mCTAs, mCIAs, mNISAs, mC-PICA and the model Commercial Hub and Spoke Agreement will not be accepted in new IRAS submissions after 30 September 2025.
What does this mean for sites currently waiting to sign mCDAs or are still in set up?
Any agreement not already exchanged (signed by both parties and notified or returned to the sponsor) can continue to be exchanged using the April 2024 version of the mCDAs or the May 2025 version of the participating organisation agreement. There is no need to move to use the latest templates if you have already started negotiations.
However, if a June 2025 version of the model Commercial Chief Investigator Agreements has been used to contract with the NHS or HSC, we recommend using the July 2025 version of the participating NHS organisation agreements.
This will support chief investigators sharing confidential information about individual studies with participating NHS organisations, when needed.
If sponsors prefer to use the July 2025 version of the relevant agreement to contract with NHS and HSC organisations, there is no need to submit an amendment to use the revised contract template.
Which agreement can I use?
Below we have explained which contracts you should use depending on which stage you are in your research project and when you need to use a template agreement.
You can access all of these template agreements on IRAS Help.
Model Clinical Trial Agreements (mCTAs)
From 30 July to 30 September 2025
To submit a new application in IRAS use either:
- May 2025 version
- July 2025 version
To exchange a new agreement use either:
- May 2025 version (unless the July 2025 version was submitted in IRAS)
- July 2025 version
From 1 October 2025 onwards
To submit a new application in IRAS use:
- July 2025 version
To exchange a new agreement:
- May 2025 version (unless the July 2025 version was submitted in IRAS) or
- July 2025 version
Model Clinical Investigation Agreements (mCIAs)
From 30 July to 30 September 2025
To submit a new application in IRAS use either:
- May 2025 version
- July 2025 version
To exchange a new agreement use either:
- May 2025 version (unless the July 2025 version was submitted in IRAS)
- July 2025 version
From 1 October 2025 onwards
To submit a new application in IRAS use:
- July 2025 version
To exchange a new agreement:
- May 2025 version (unless the July 2025 version was submitted in IRAS) or
- July 2025 version
Model Non-Interventional Study Agreements (mNISAs)
From 30 July to 30 September 2025
To submit a new application in IRAS use either:
- May 2025 version
- July 2025 version
To exchange a new agreement use either:
- May 2025 version (unless the July 2025 version was submitted in IRAS)
- July 2025 version
From 1 October 2025 onwards
To submit a new application in IRAS use:
- July 2025 version
To exchange a new agreement:
- May 2025 version (unless the July 2025 version was submitted in IRAS) or
- July 2025 version
Model Commercial Participant Identification Centre Agreement (mC-PICA)
From 30 July to 30 September 2025
To submit a new application in IRAS use either:
- May 2025 version
- July 2025 version
To exchange a new agreement use either:
- May 2025 version (unless the July 2025 version was submitted in IRAS)
- July 2025 version
From 1 October 2025 onwards
To submit a new application in IRAS use:
- July 2025 version
To exchange a new agreement:
- May 2025 version (unless the July 2025 version was submitted in IRAS) or
- July 2025 version
Model Commercial Hub and Spoke Agreement
From 30 July to 30 September 2025
To submit a new application in IRAS use either:
- May 2025 version
- July 2025 version
To exchange a new agreement use either:
- May 2025 version (unless the July 2025 version was submitted in IRAS)
- July 2025 version
From 1 October 2025 onwards
To submit a new application in IRAS use:
- July 2025 version
To exchange a new agreement:
- May 2025 version (unless the July 2025 version was submitted in IRAS) or
- July 2025 version
Model Confidential Disclosure Agreement (mCDA)
From 30 July to 30 September 2025
To exchange a new agreement use either:
- April 2024 version
- July 2025 version
From 1 October 2025 onwards
To exchange a new agreement use:
- July 2025 version
Model Master Confidential Disclosure Agreement (mMCDA)
From 30 July to 30 September 2025
To exchange a new agreement use either:
- April 2024 version
- July 2025 version
From 1 October 2025 onwards
To exchange a new agreement use:
- July 2025 version