Early feedback - commercial

Access our online submission system

This service provides expert guidance for protocol development, set-up and/or the decision to place a study in the UK.

Benefits

  • A rapid assessment of feasibility by national clinical specialists based on their understanding of current UK practice, prevalence of the relevant patient population, and network knowledge of the UK research landscape, such as competing studies.
  • Accelerated set-up through early discussion with our local Network teams who can assist with local site negotiations and R&D submissions.

Typical uses

  • “We are putting in a bid for a study to be placed in the UK, can you help me in assessing the ‘do-ability’ for this protocol in the UK?”
  • “We have an early study synopsis and would like feedback on the design to advise our protocol development team.”
  • “We have a draft protocol which we think can be done in the UK but would like advice on where to find the right patients and an estimate of patient numbers and sites.”

To start a review, we need the following information:

  • Draft protocol or synopsis
  • Any specific questions on which you would like feedback. For example: the impact of any specific disallowed medication or availability of a laboratory test
  • Timelines for start/end recruitment (global and UK if known)
  • Whether your study is definitely placed in the UK or you are currently bidding for it
  • Whether you require specialist clinical input to the study design
  • Information on any feasibility done to date

Timelines and what to expect

Once you have completed the online submit my study form, the timelines are:

Within the same day:

  • An email notification to acknowledge the submission of your information

Within two working days:

  • A call or email back if the Network has any additional questions to ask.

Service timelines after three working days:

  • Early feedback: Complete information sent to you within a maximum of 10 working days of submitting your request with the necessary study details to the network.

Eligibility Criteria for NIHR Clinical Research Network support of commercial studies

In order to be eligible for inclusion on the NIHR CRN portfolio, commercial studies i.e. those which are fully commercial, both fully industry supported and partly industry supported must be submitted via this online system by a member of the sponsoring company or Clinical Research Organisation (CRO) for assessment against the following eligibility criteria, as defined by the Department of Health:

  • The study must meet the definition of ‘research’ - According to the current Department of Health policy document, ‘Eligibility criteria for NIHR Clinical Research Network Support’, research can be defined as "the attempt to derive generalisble (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods. This excludes: audit; needs assessments; quality improvement and other local service evaluations. It also excludes routine banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis. NHS Research Ethics Committee approval and NHS permission are prerequisites for research to be supported via the NIHR CRN."
  • The study must receive NHS Research Ethics Committee approval and NHS permission prior to initiation at individual sites.

The Network will use the information you supplied in the submission to ensure that the above criteria are satisfied, if there are any questions relating to the above, a Network representative will contact the applicant for clarification. 

 

Email our Study Support Help Desk, or call on 0113 34 34 555 to put in place or check for existing agreements.

Sharing confidential information when using our feasibility service

We treat any information you disclose to us as confidential and do not share it with any unauthorised third party. Our CRN Confidentiality Disclosure Agreement (CDA) puts this in writing.

Information submitted by companies to the CRN in relation to Portfolio eligibility and feasibility assessments can be of a confidential nature therefore arrangements have been put in place, underpinned by a set of generic confidentiality agreements, which facilitate discussions between a company, the Clinical Research Network and researchers while maintaining confidentiality.

These arrangements were developed with the Life-science’s industry through the NIHR Clinical Research Network Industry Roadmap Group and endorsed by the Association of British Pharmaceutical Industry (ABPI). The confidentiality agreements only need to be signed once to cover any future discussions between the Clinical Research Network and companies wishing to submit studies for our feasibility services and inclusion on the Portfolio. Further information regarding the structure of these agreements and what they cover can be found in our guidance document in the list of links below.

Distribution of confidential information

These arrangements do not enable the Clinical Research Network to share confidential information with selected study sites in relation to site set-up. The provision of any confidential information to a site research team should be provided by the Sponsor or relevant CRO under the terms of their own confidentiality agreements.