10 step guide: Study Support Service for the life sciences industry

Create or log into your CPMS account

Our Central Portfolio Management System (CPMS) is the foundation of our Study Support Service. It is the only UK-wide system which collates real-time research activity data and related information and enables all our research intelligence, insights and many of our support services. This system is currently separate from the Integrated Research Application System (IRAS).

Create an account and log in to CPMS and request our services from within your CPMS account. You will need to provide some information about your planned research activities.

• Read our Getting started and logging in to CPMS guide
• Go to CPMS to create your account and initiate study support
• You can use the same log-in details to access our CPMS training module (on NIHR Learn) to help you navigate the system.

Sign our Confidentiality Disclosure Agreement

All information shared through CPMS is protected under our Confidentiality Disclosure Agreement (CDA). This specifically covers the NIHR Study Support Service. (It is different to the NHS model Confidentiality Disclosure Agreement which companies use directly with NHS providers).

• When you submit a study for support you will need to declare that a CDA is in place with your company, or you will be directed to complete one.
• To find out if your organisation already has a CDA in place email: supportmystudy@nihr.ac.uk
• Learn more about our Confidential information arrangements for the life sciences.

Get expert advice to optimise your proposed protocol

You need to be confident that your proposed protocol is both feasible and deliverable in the UK. This includes an opportunity to check how patient-friendly it is.

3a. Ask our clinical experts how feasible your study is in the UK

Our NHS experts will advise on the feasibility and deliverability of your protocol in the intended NHS or wider care environment.

• You will need to request 'Early Feedback' in CPMS to initiate this service. You will also need to provide basic information about your study, for example, study synopsis, proposed timelines, stage of country selection.
• You will hear back within 10 working days through your CPMS account.
• 2-3 National Specialty Leads (NHS clinicians) will provide feedback on aspects that may affect successful delivery such as: study complexity; compatibility with UK clinical practice; patient populations; recruitment strategy and setting; timelines; competing studies across the UK.
• You may add specific questions for feedback, for example, test the validity of your exclusion and inclusion criteria.
• The clinical experts providing feedback may also share their contact details through this service as an early expression of interest to become an investigator.
• More info: Watch this video on our expert protocol review and feedback service.

3b. Get patient perspectives on your proposed research

Our Patient Engagement in Clinical Development service has been designed specifically for life science companies to help you to engage directly with patients. Accessing this service before your protocol is finalised will enable patient insight to be implemented to improve the design of your research. We can arrange and facilitate a range of engagement activities, in-person or virtually, with groups or individuals.

• This is a separate, paid-for, service to ensure patient time is reimbursed.
• Supplement this by exploring our guidance for improving inclusion of under-served groups in clinical research.

3c. Discover digital engagement tools to support feasibility and recruitment

We can advise you on digital tools and systems that can help understand where the best recruitment opportunities exist, for example by exploring disease prevalence and other indicators. Services such as the Be Part of Research registry and Join Dementia Research registry, can also help promote your study to participants, and directly support recruitment.

• Get in touch for advice on which tools are right for your study.
• Apply online to promote your study to NHS participants via Be Part of Research
• Apply online to access the Join Dementia Research registry

Find sites for your study across the UK

Once you have optimised your proposed protocol for delivery in the UK based on the activities described in step 3, we can help you to look for sites that have capacity and capability to deliver your research.

4a. UK-wide site identification service

A single submission will initiate our UK-wide site identification service. We work with partner organisations in Scotland, Wales and Northern Ireland to quickly gather expressions of interest from sites that are willing to participate in your study. This includes NHS sites (primary care/general practice, secondary care/hospital sites and Patient Recruitment Centres), and the wider social care environment. If you have already identified some (but not all) of your sites you can still use this service.

This is the UK’s only nation-wide site identification service. It provides a complete picture from which you can begin to target your site selection activities.

• Submit your study synopsis or draft protocol for this service in CPMS
• We understand that confidentiality is paramount. We do not share the protocol directly with sites or distribute company site assessment questionnaires requiring in-depth information. We share the minimum information required to assess capacity and capability. You retain control of when you share confidential information directly with interested sites.
• You can add specific questions into the Expression of Interest request to ensure you get responses from sites with the necessary expertise, capability and capacity.
• You will receive responses within 15 working days in CPMS, including contact details.
• Review the responses in CPMS and engage directly with the interested sites to progress your site selection.
• If you already have sites in mind, share these in CPMS. This is essential to:
  
  • Generate site level costs at the costing stage (see step 5 below)
  • Maintain the integrity of national research activity data which underpins distribution of research delivery resources.
• Help keep sites informed and engaged by also sharing non-selection feedback, either to the contacts directly, or via the Study Milestone Schedule (see step 8 below).
• Watch this helpful video explaining how we help find sites for your study.

4b. Associate Principal Investigator Scheme

Our Associate Principal Investigator (PI) Scheme is developing the investigators of the future and helping to grow research delivery capacity within our healthcare system. The scheme creates opportunities for health and care professionals to gain practical experience of delivering research under the mentorship of an enthusiastic local Principal Investigator (PI). Studies that register for the scheme receive increased support at a site level.

• Learn more and register your study for NIHR Associate PI scheme

Calculate the cost of your study at sites

Since 2008, the UK has provided a single costing approach for commercial contract research which calculates the cost/price of a study for participating sites based on the resource required to deliver the research activities set out in the study protocol. UK-wide implementation of the National Contract Value Review (NCVR) process for commercial research taking place in an NHS setting commenced on 1 October 2022. It is now mandatory for all late phase commercial trials taking place in NHS organisations and will expand to early phase research in 2024.

To calculate your costs:

• Read the top tips and access all the guidance (below) before you get started.
• Log into your CPMS account to access the UK interactive Costing Tool (iCT) .
• Shape the content in the iCT to reflect the resource requirements of your study. You can initiate the iCT at any time and update it as your protocol develops to understand the cost impact on your study budget.
• Do not submit your iCT for Study Resource Review until,
  
  • Your study is ready for submission for UK study approvals (via IRAS) and,
  • You know your Chief Investigator and lead site.
• Once you have submitted your iCT you will be linked with an NHS costing expert who will work with you to review the resource requirements and undertake negotiation until approval is acquired by both sides.
• Once approved, no further negotiation will take place. The iCT will use the agreed study resource requirements to generate site-specific prices for use in the model agreement financial appendix (your study contract with each participating site).

Further information and guidance:

• Watch the helpful video (below) to learn more about the UK interactive Costing Tool.
• Read our UK interactive Costing Tool: Getting started guidance document. It includes links to handy video tutorials, infographics and FAQs.
• Access the single technical reviews for Pharmacy and Radiology by UK-wide expert groups as this information will help inform the study resource requirements.

Our 'Top Tip' to consider before you start:

• You are required to submit your initial resource requirements within the iCT at the same time as submitting your study for UK approvals via IRAS. This streamlined approach enables your Combined Review and iCT resource approval to be completed in parallel, within the target 30 day period set by the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA).

Confirmation of UK study approval

IRAS is the single system for gaining regulatory approval and ethical approval (assessment of governance and legal compliance) for your study in the UK.

Once you have your approvals in place, your study support service contacts for each participating site are the local Clinical Research Networks (CRNs) or devolved administration equivalent. Your Lead CRN - the region where your Chief Investigator is based - provides a broader study wide support role. Our national network structure enables collaborative working and sharing of insights to overcome challenges during study set-up and delivery.

Schedule a study start-up call

We understand how important it is to get from approval to recruitment quickly. A study-wide start-up call can help you to open multiple sites efficiently by sharing anticipated challenges and potential solutions with all sites.

• Accept your email invite offering a study start-up call - it can take place any time after you have your approvals in place.
• The agenda is specific to your study and the outcomes are shared to all your study sites.
• Important: Ensure all contacts are added/updated in the study record. You can manage who has access to protect confidentiality of the study information.
• Watch this helpful animation to learn more about study start-up support.

Share your final protocol with us to enable further support

We automatically assess your study for inclusion on the CRN Portfolio when you access our site identification service. If your study is confirmed for NIHR Portfolio inclusion, you will benefit from further support.

• A Network contact is assigned to your study. This person is your key point of contact and is responsible for monitoring the progress of your study until closure.
• Your Network contact has access to our national network of research expertise and experience to seek support for rapid issue resolution and/or request additional support, sites etc.

To initiate this support you must:

• Provide a copy of your final approved protocol - this will be requested by email.
• Ensure contact information is updated, especially if another colleague or team will be leading study delivery after set-up.
• Complete a Study Milestone Schedule using the template we provide. This is a live document for use throughout the study life cycle. Its content is used to ensure study records and site-based teams are up to date. It also provides a formal mechanism to provide feedback to non-selected sites which helps us monitor capacity and capabilities across the system for other studies.

Coordinate your communications with key contacts

Optimise the support you receive by keeping everyone in the loop. It is best practice to include the CPMS number in all email subject lines; we continually support over 5000 studies, this reference number helps us quickly direct support.

From this point forward, starting with the Local Site Information Pack, you should also include the following contacts in all your correspondence to sites.

• Network contact.
• The relevant Local Clinical Research Network contact or devolved administration office for each participating site.

Update your study status to ensure ongoing support

Visibility of real-time research activity data helps us to utilise all the capacity in the health research system to deliver research quickly and efficiently. To optimise support for all studies we support, including yours, we need accurate study data in our system. In the UK, new terms and conditions have been introduced which allow research delivery support to be withdrawn if study data is not adequately maintained.

Reporting changes to study status: Sponsor Engagement Tool

Our Sponsor Engagement Tool enables sponsors (and their delegates) to provide regular assessments of study progress and ensure the data we hold is up-to-date. If your study appears to be behind schedule, we will seek to understand why.

• Support on how to access and use the Sponsor Engagement Tool will be available to you when your study is live.
• Access the Sponsor Engagement Tool via the NIHR Identity Gateway (the same way you access NIHR Learn).

Acknowledging global or European first participants

• Our recruitment data only covers the UK.
• Please inform your Network contact if your study is running in other countries.
• Please also inform us if a UK site is likely to recruit the first global or European participant, as this is an important performance indicator.

Adding more sites

If you need to scale up recruitment or want to increase your geographical spread, your Network contact can support you to engage additional or alternative sites through our Network. This partnership approach ensures the outreach is bespoke to your individual study requirements and uses existing information already in CPMS.