Our work as part of UKCRD to streamline and reform study set-up

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.

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 from 19 May.

We further updated the model Commercial Chief Investigator Agreement following feedback from industry in a HRA Now bulletin issued on 20 June. This update also published a contract research organisation version of the agreement.

Additional work to support study set-up

On 27 June 2025 we published a new template amendment history log to help make it easier for sites to be updated on amendments.

The log was developed alongside the devolved administrations, commercial and NHS sponsors, sites and participating organisations, and is based on wider feedback on the challenges of implementing amendments.

We hope this template will make it easier for amendments to be shared consistently.

Read more 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.

As part of this work, we are considering developing chief investigator agreement templates for other study types.

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.

Below is an update on the progress we've made so far on this workstream.

Radiation Assurance

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.

New guidance

We have published new guidance on the UKCRD website to help improve understanding of the Ionising Radiation (Medical Exposures) Regulations 2017 (IR(ME)R17) applicable to England, Scotland, and Wales, and the Ionising Radiation (Medical Exposures) Regulations (Northern Ireland) 2018 (IR(ME)R18) applicable to Northern Ireland, and subsequent amendments.

The guidance was developed in response to inconsistencies identified by the UKCRD programme, and provides key clarifications on interpretation, approval processes, and legislation to make study set-up and research delivery easier.

Read the guidance.

Pharmacy Assurance pilot with ECMC

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 the pilot opened to sponsors in June 2025.

The pilot will generate insights to support wider adoption across other disease areas and clinical trial phases.

You can take a look at the draft guidance for sponsors, sites and pharmacy departments on the ECMC website.

Information governance

To support the UKCRD programme, we prioritised our 7 proposals for improving information governance (IG) and took forward 3 proposals in Summer 2025 that we have now published:

• make visible the criteria for how IG is reviewed at study-wide review (SWR)
  • we have taken the version of our whole SWR criteria that was available on our website as a downloadable pdf and made it more visible by republishing as webpages directly onto our website
  • we have updated section 5.1 (the IG) section of our SWR criteria and made it easier to read, understand and use by updating the presentation, structure and formatting of the IG SWR criteria without changing the meaning of the content of the criteria.
  • Read the SWR criteria here
• improve IG training for study-wide reviewers and make this visible
  • to ensure that our staff feel confident in their knowledge and ability to apply the principles of IG to health and care research, we have worked with the HRA’s learning and development team to develop a new training resource for our staff. This new training will be available digitally and covers the following areas:
    • aims and legal foundations
    • key definitions
    • personal vs anonymous data
    • legal bases under UK GDPR
    • confidentiality and consent
    • data subject rights, exemptions and safeguards
    • transparency requirements and wording
    • data transfers
    • use of confidential data without consent
    • review and assessment
• clarify ‘good practice’ standards for IG evidence in IRAS submissions for sponsors and sites

We have published new guidance aimed at research sponsors and research sites to clarify good IG practice when sponsors are submitting research studies for review. This guidance is to be used by sponsors to support their submission of IG evidence as part of their IRAS submissions. Sites can use the guidance to support their assurance of the IG review that has taken place centrally as part of the review of the research study and to understand what local IG support research sponsors should be providing to research sites.

You can read more the work we've done to improve the assurances given as part of the information governance review on our website.

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