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User guide for the NIHR study Support Service: Industry Route Map

 

Contents

Introduction - Why get involved?

The NIHR Clinical Research Network (CRN) has worked with the NHS in England to facilitate clinical research since 2006. It is government funded and offers unique support during start-up and recruitment through performance monitoring via metrics and sponsor collaboration - you win, they win, we all win!

Regarding matters of confidentiality

You can sign a Master Confidentiality Disclosure Agreement (CDA) with the NIHR Clinical Research Network, which covers all NIHR Clinical Research Network staff across the 15 regions in England. However, confidentiality with individual sites is arranged by you as the sponsor when engaging with sites.

Starting point

Create a Central Portfolio Management system (CPMS) account (your access to all NIHR/network services). Need some help? see step by step guide.

 

Key Steps

Why Early Contact and Engagement?

If you’ve never used the NIHR services before – this is a great place to start as you can find advice on ‘eligibility for support’ from the Clinical Research Network, ‘regulatory submissions’ and ‘completion of costing templates’ including the new interactive costing tool (iCT), which is available from April 2019, ‘exploration of recruitment pathways’, ‘Good Clinical Practice (GCP) training access’ and ‘local intelligence’ to optimise delivery of your study.

Simply contact the Study Support Service Helpdesk and you will be put in touch with the most appropriate contact point for your study. You should hear from them within 3-5 working days.

 

Why Early Feedback?

For best results, use this service before your study design is finalised. By completing a simple online form, you can quickly check the viability of your study in the NHS in England (including primary care and social health research). Answer a few standard questions (with the opportunity to add your own specific questions – for example test your inclusion and exclusion criteria) and if you have your early (draft) synopsis, include that too. Remember, you may receive negative feedback, which can help you avoid a costly disaster by ensuring you take your study elsewhere or redesign your study to meet with NHS standard of care.

This service engages 2-3 anonymous clinical experts who will look at study complexity, patient populations, timelines and recruitment strategy, offering suggestions and adjustments that can aid delivery.

This service can also check whether there are any competing studies in NHS England based on the timelines you provide.

There is an opportunity for any of the experts to provide their contact details if they would be interested in getting involved in your study, and you will hear back within 10 working days through your online CPMS account.

After using the services, it always pays to say, ‘thank you’ (which can be done via the feasibility team) - remember this is a free service and by courteous behaviour the service will continue to offer valuable and time critical advice.

 

Why Site Identification?

Through the Network, including the devolved nations (Scotland, Wales and Northern Ireland) at this stage, you can identify interested sites with capacity and capability to perform your study. By sharing (limited) study information via CPMS (by ticking the relevant box in CPMS) the details you complete in 'Part B' are sent to potential sites – note this is blinded to maintain confidentiality and the protocol is not shared.

Within 15 working days expect a windfall of ‘Expression of Interests’ (EOI), which are just as they sound – investigators/sites keen to be involved in your study. The EOI are uploaded weekly (on Fridays), again into your CPMS account, so you will start to receive some feedback earlier than 15 days. 

The Positives

Access to clinical trial NHS sites across the UK in one swoop and an opportunity to identify totally ‘green shoot’ sites (new to conducting commercial clinical trials) and/or sites that are ‘new’ to you… thus avoiding the 'all your eggs in one basket' scenario!

The Negatives

Can be overwhelming – as there is no guarantee on the number of responses you may receive 1 or 2 or hundreds! Note, the quality is underwritten by the 15 Local Clinical Research Networks and Scotland, Wales and Northern Ireland.

Also, it could be that a Local Clinical Research Network completes the form on behalf of sites within their region, so it won’t always be the potential investigator him/herself.

So, what's expected of you? Basically nothing, however why ask if you're not going to do anything with the EOI received? In many cases you may wish to run ‘site identification’ in parallel to your own feasibility processes – we’d suggest it is ‘enhanced’ rather than ‘replaced’. And please be encouraged to respond to sites who have completed/returned an EOI – as it's a free of charge service and we want to constantly encourage good feedback, a little thank you goes a long, long way!

 

Why Site Intelligence (Optimising delivery)?

You may not be planning on using the NIHR services as outlined above, for example – your protocol is final already and you have your sites identified. However, it may still be necessary for you to have your study accepted onto the NIHR Clinical Research Network Portfolio as this gives you access to all NIHR Clinical Research Network services in England, which includes validation of your costing template and allows you to engage the Network's performance monitoring of your English site.

Submitting your study into CPMS for Site Intelligence, which includes sharing the site list and key study timelines and information, the NIHR will start the process of contacting local Clinical Research Networks to utilise local study site and study data and expertise on previous performance to identify any potential resource issues or competing studies, [note this does not currently apply to devolved nations]. Within 15 working days you will receive confirmation on your pre-selected sites through ‘Site Intelligence’.

Site intelligence is an opportunity to check the sites you have already identified. In this case, the Local Clinical Research Network will confirm that the sites you have pre-selected will be supported by them to deliver your study. If the Local Clinical Research Network have concerns about any site, they may indicate they are not prepared to support this site on your study (red flag to a bull - ignore at your peril!!!) - but you can go ahead!

 

Why effective study set up?

A new service to be offered for commercial research from 2019. Once included on portfolio – you can enhance the support you receive from each Local Clinical Research Network where you have a site in set up by simply including them in copy on all site communication (using the Local Clinical Research Network industry email addresses). You can do this from the very start when sending out the initial Local Information Pack (LIP) to each site!

There is also the offer of a study start-up call to discuss the study and any challenges which may be present during the set-up and delivery of the study in the UK. The outcome of the call is shared with Local Clinical Research Network contacts who will communicate with their study sites to raise awareness of any delivery challenges identified and support overall study delivery to time and target. This call is an opportunity for you to learn more about the NIHR Study Support Services and to ask any questions you may have.

Important Documentation – the study milestone schedule (SMS)

This forms a living ‘agreement’ between you and the Clinical Research Network outlining the sites, the recruitment target (across English sites) and the study recruitment time lines - all submitted by email. As it’s a living document’ it works best if you send it in early (when sites first selected) and then update regularly, for example when:

  • new sites added
  • a site is closed early
  • performance Review Lead Patient recruitment targets change
  • recruitment time lines change and importantly
  • when company study contact changes.

The Company Contact details in CPMS (who holds the account) will remain constant. This can be changed by updating the Study Milestone Schedule and returning it to the generic email: crncc.support@nihr.ac.uk. To facilitate open communication with the Clinical Research Network it is essential that your study day-to-day contact is current, so please keep it up to date.

 

Why performance monitoring?

A Performance Review Lead (PRL) will be assigned to your study, their contact details will be included in the Study Milestone Schedule for your study along with your own details. If you have already been receiving support in start-up (see above) this should follow on seamlessly!

You can contact your PRL to discuss the potential recruitment or other study related challenges for your study, which may be a continuum of your set-up conversations. The intention is to share potential challenges across the relevant Local Clinical Research Networks where your study is taking place (forewarned is forearmed!!)

After site activation, your PRL will be your ‘go to’ person if your sites/study start to struggle…

Remember this is 'monitoring' not 'management' and in many cases, activities the Clinical Research Network will support are what you as Sponsor are already doing - don't get frustrated with this - ensure open three-way communication to get the best results!

During the recruitment phase - sites will be uploading study recruitment data into the Local Portfolio Management System (LPMS) system, which feeds up into CPMS. Monthly your contact (details on the SMS) will receive the site / study recruitment metrics. From Q3 2019 the industry study contact will be responsible to 'validate' the CPMS data, by doing this you support the PRL’s centralised overview of your study performance.

Where studies are struggling (appear to be falling significantly behind target according to the Clinical Research Network data) the PRL will reach out to you to discuss the best course of action. Or if you have concerns, you can contact them at any time.

Currently once your study completes recruitment, the national Clinical Research Network support officially ends, however, you still have the opportunity through the local Industry Operations Manager for each region, to have support for any quality issues or concerns you might have. In addition, when your recruitment is complete, there is an opportunity to provide feedback on the services, which supports key learnings and process improvement for when you use the services again.