In addition to the HRA’s role in reviewing research applications, one of our key functions as an organisation is to co-ordinate and standardise the processes that researchers, sponsors and research sites have to follow.
Once we have approved a research application, it is important to get the study started as quickly as possible so people can take part.
Doing this quickly means the study is completed faster, and the potential benefits are realised sooner.
While progress has been made in accelerating regulatory approvals (something that’s a key part of our strategy) delays in site set-up remain a challenge, particularly in commercial research.
The government has pledged to cut the time it takes to get a clinical trial set-up to 150 days by March 2026.
UK Clinical Research Delivery (UKCRD)
The Department of Health and Social Care (DHSC) has established the UK Clinical Research Delivery (UKCRD) programme, a cross-sector programme of work aimed at creating a faster, more efficient, more accessible and more innovative clinical research delivery system – making the UK a world leader in clinical trials.
As part of the UKCRD programme one of the key priorities is to streamline and reform the set-up and delivery of clinical trials.
To deliver this DHSC is leading a sector-wide plan on behalf of all UK nations which has four key workstreams.
The Health Research Authority is leading on two of these workstreams:
- workstream one - develop and mandate an efficient and streamlined single UK standardised commercial contracting process to reduce unnecessary negotiation and remove duplication of activity that can be done once on a per study basis during study set-up
- workstream two - remove duplication of activity that can be done on a per study basis during study set-up by making it easier to understand and accept assurance from Pharmacy and Radiation Technical Assurances and Information Governance study-wide reviews
We are closely involved in the two other workstreams which are focusing on site level study set-up performance data and a single UK-wide non-commercial costing model.
You can find out more about the different workstreams by watching this UKCRD webinar.
Workstream one
An efficient and streamlined single UK standardised commercial contracting process
The contracting processes for health and social care requires agreement to be in place between the research sponsor and each site where a study is taking place.
To help make that contracting process easier we have developed a range of model templates which should be used by researchers. Using these pre-agreed templates makes the contracting process faster by removing the need to negotiate individual contracts at sites for every study.
The range of model templates work alongside the National Contract Value Review (NCVR), which has already reduced commercial study set-up times by a third since October 2023.
Our progress so far
On Monday 19 May 2025 we updated the commercial agreements for use with participating NHS and HSC organisations.
The following suite of agreements were updated:
- model Clinical Trial Agreements (mCTAs)
- model Clinical Investigation Agreements (mCIAs)
- model Non-Interventional Study Agreements (mNISAs)
- model Commercial Participant Identification Centre Agreement (mC-PICA)
- model Commercial Hub and Spoke Agreement
The changes to the agreements have been made to make it easier to reflect NCVR negotiated and non-NCVR negotiated financial arrangements.
In April 2025 we published a new model agreement and updated expectations on another.
The Model Commercial Chief Investigator Agreement (mCCIA) was launched on Monday 28 April. We expect that this agreement and the Model Confidential Disclosure Agreements (mCDAs) are used without modification from this date.
The mCCIA was first published as a draft in November 2024. We asked for comments on the draft agreement and based on the feedback we received have standardised certain areas of the agreement, addressed concerns raised by stakeholders and made the agreement easier to understand and use.
The Model Confidential Disclosure Agreements are legal agreements that are often used in commercial contract research to govern the sharing of confidential information from the commercial sponsor to the prospective participating NHS or HSC organisations prior to the site agreement.
Using either the mCDA or the Model Master Confidential Disclosure Agreement will help streamline the commercial contracting process and reduce unnecessary negotiation.
You can read more about mCCIA and mCDAs in our HRA Now bulletin.
Next steps
We are currently exploring an agreement for use after site selection to clarify the roles, responsibilities and expectations of sponsors, and NHS and HSC organisations during site set-up.
We have also received requests for a contract research organisation (CRO) version of the mCCIA agreement and we are committed to publishing a CRO-mCCIA as soon as possible.
As part of this work, we are considering developing chief investigator agreement templates for other study types.
Workstream two
Reducing unnecessary duplication of our study-wide review for information governance and improve the effectiveness and consistency of Technical Assurances
This workstream focuses on reducing unnecessary duplication of our study-wide reviews for information governance and improving the effectiveness and consistency of Technical Assurances.
Technical Assurance is a review process that we offer for studies that involve pharmacy (CTIMPs) or ionising radiation (which includes things like x-rays and radiotherapy).
As part of the process applications are reviewed by independent experts who provide key technical information to regulatory bodies and sites, to support study set-up.
Our progress so far
We provided a policy statement about the interpretation of the Ionising Radiation (Medical Exposure) Regulations (IR(ME)R), for DHSC to take to the Care Quality Commission and IR(ME)R regulators in the devolved nations.
In collaboration with The Experimental Cancer Medicine Centres (ECMC) Network, the HRA is leading a pilot to test a streamlined study set-up pathway and mandated Pharmacy Assurance process within early phase oncology trials via the ECMC Network.
Together with sponsors, NHS research and development offices and pharmacists, we have written new guidance which will be tested through this pilot.
Training will be delivered from May 2025, and sponsors will be able to enrol in the pilot from June 2025.
The pilot will generate insights to support wider adoption across other disease areas and clinical trial phases.
We have also agreed our plans for prioritising the seven proposals for improving information governance we made in 2024.
Three of these proposals are being taken forward by summer 2025:
- make visible the criteria for how information governance is reviewed at study-wide review
- action – updated and visible study-wide review criteria for information governance which research studies submitted for HRA and HCRW Approval (and equivalent processes in Northern Ireland and Scotland) are assessed, describing the standards that sponsors are expected to meet
- improve training for study-wide reviewers and make this visible
- action – updated and visible study-wide reviewer training
- clarify ‘good practice’ standards for information governance evidence in IRAS submissions for sponsors and sites
- action – a new and visible information governance checklist for sponsors and sites, containing explanatory guidance on ‘what good looks like’ from an information governance perspective
Further work in this area
We recently carried out a survey asking the research community to rate their experience of study set-up in the UK to help us track the progress we are making to improve the process.
In May 2025 we will be sharing the results this survey.
Get in touch
If you have any questions about any of our work to improve study set-up please contact:
- for model agreements email research.agreements@hra.nhs.uk
- for queries on the Pharmacy Assurance Pilot email pilot.testing@hra.nhs.uk