Set-up service


As the Clinical Research Network is a government funded organisation, all studies must meet certain eligibility criteria as defined by the Department of Health to qualify for our free support and gain entry onto the NIHR CRN Portfolio: the database designed to capture activity data enabling effective activity management and accurate feasibility. Public access search of the NIHR CRN Portfolio is provided from the UK Clinical Trials Gateway.

The eligibility check for the CRN portfolio is quick, simple and should be performed prior to or in parallel to regulatory and HRA Approval submissions to avoid any delays to study start-up. Our study start-up route map demonstrates how this process aligns with study set-up.

To get started, or for further information, please contact our Study Support Service Helpdesk:
t: 0113 34 34 555
e: supportmystudy@nihr.ac.uk

Get the best out of our dedicated tools for efficient study set-up times:

Commercial Study Costing Templates

The Industry Costing Templates provide a framework for transparent cost display and calculation to support swift local site budget negotiations when performing commercial trials in the NHS.

Access the latest Industry Costing Templates – 16/17 version

Costing templatesThe excel template required depends on the type of study you are running. Use the table below to determine which is appropriate for your study and download from the links at the bottom of this page (please note that the phrase ‘researching’ is intended to also include observational studies). They are updated annually and sometimes in between so download the master version for each new study to ensure you have the latest template. Please enable your macro settings in excel prior to opening the files to activate the automated features.

Site and investigation question

The study site is in the Primary Care setting e.g. GP surgery

The study site is in the Secondary Care setting e.g. NHS hospital

The study is researching or observing a drug product

Download the Primary Care Industry Costing Template

Download the Secondary Care Industry Costing Template

The study is researching or observing a medical device, with or without a drug product

Download the Primary Care device-based Industry Costing Template

Download the Secondary Care device-based Industry Costing Template

Want to know what has changed from the previous template version?

Review the summary of the annual revisions made to the templates in April each year for the new financial calendar.

Need to get your template validated?

The Local Clinical Research Network leading on the study (usually where the Chief Investigator site is located) will perform a quick ‘Quality Check’ or validation of the master study template via the Local CRN Industry team single point of contact.  To get the most benefit from the validation, ideally this occurs prior to HRA Approval submission.  However, the validation can occur in parallel to HRA Approval submission. See what checks are included in the validation here. The final stage is gaining cost approval from each individual NHS organisation.

Including the template costs in the contract?

The recommendation is to use the nationally approved model agreements (see next tab) which remove the requirement for lengthy legal review on a study by study basis, saving valuable time during site set-up. The NIHR CRN Costing Group has developed suggested content for the Financial Appendix of the model agreements to support the inclusion of the costing template into this contract.

Need to update the costs in the contract?

The NIHR CRN Costing Group has developed suggested content for a change order template for the model agreement.

NHS Organisation Invoicing and Income Distribution

The Industry Costing Template includes built-in functionality to support the generation of invoice information to confirm with the Sponsor Company and to inform the NHS Organisation Finance Team raising the invoice. The template functionality includes the ability to describe the income distribution of the commercial income for all participating departments.

Help us to improve the Costing Template

If you have any suggestions for improvements to the template, please complete this form so that they can be considered.

Making the most of the Industry Costing Templates

As a study budget is a required document for your HRA Approval submission, the CRN offers a range of support to help you complete and validate the Industry Costing Template for your study:

  • Not used the templates before? Read our guidance document to understand the aims of the template, its terminology and components. The guide also includes a list of FAQs.
  • Have a new study to cost? Use our step-by-step completion guide or listen to our audio training sessions on our Bright Talk channel to learn more. There is a dedicated training session specifically for the Pharmacy worksheet to ensure the whole template can be completed as thoroughly as possible.
  • Support with specific procedures? A list of therapy area related procedures additional to those listed in the template are provided below to support the inclusion of representative values.

If you have any trouble using the templates or suggestions for improvements please contact the CRN industry team at supportmystudy@nihr.ac.uk.

Model Clinical Agreements

Model Clinical Agreements for IMP and Device studies involving Sponsors and/or CROs in Secondary and Primary Care settings

Model agreementsThe NIHR CRN advises the use of ABPI model Clinical Trial/Investigation Agreements when contracting between Life Sciences companies including CROs and NHS Organisations or GP Practices. These are nationally accepted contract terms which have been specifically developed to remove the need for per study contract reviews when working with the NHS. They are also a required document for HRA approval submission for commercial studies.

These agreements are designed to be used ‘off the shelf’ without modification and are available for a range of various research scenarios. Any modifications to the template wording may result in study delays due to the potential requirement for a legal review.

 

Find out more or download the model agreement templates from the NIHR website

Help and support

If you require advice on the use of the model agreements, please email supportmystudy@nihr.ac.uk.
If you feel that the model agreement does not meet your company’s requirements, please contact the ABPI.

Local pharmacy review of research studies

Guidance documents have been created to support the transfer of information between Pharma/ CROs and NHS Pharmacies to support smooth set up and delivery of studies.

When a clinical trial involving an Investigational Medicinal Product (IMP) is hosted in or through the NHS, a local pharmacy review on behalf of the NHS organisation providing care, is conducted before NHS permission is granted. This is for the following reasons:

  1. The pharmacy review forms part of the local governance check. Trial activities are reviewed to ensure that there are adequate arrangements and resources (the capacity and capability) within the pharmacy department to support the requirements of the trial.
  2. The information provided to complete the review allows a local financial review and any significant cost discrepancies to be considered and resolved.
  3.  The Chief pharmacist or another nominated deputy often has the delegated responsibility for IMP management and accountability within the organisation. Prospective trial activities will be reviewed to enable compliance
  4. Pharmacy staff use this information to continue the development of set up activities which in turn ensure effective setup and delivery

Guidance and FAQs on information requirements for local pharmacy review of research studies

The Guidance Document outlines the detail of what NHS pharmacy require from Sponsors / CROs to enable a timely local pharmacy review process to occur, resulting in trial preparation / set up with the overall one set of information requirements.

The guidance document was piloted over 20 NHS sites with more than 100 studies and is now available for NHS organisations and Sponsors /CROs to use.

Sponsors/CROs Pilot – next phase

In order to continue to affirm its fitness for purpose and to gain additional feedback from users we are asking commercial sponsors to monitor the impact of the guidance document in use. To accomplish this, Pharma/ CROs are invited to participate in the next phase of the pilot by choosing studies on which to test the guidance document.