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Research Sites & Facilities

The Chief Investigator is responsible for sourcing all potential collaborators and recruitment sites for their study (‘host’ NHS and non-NHS sites).  Contracts (model agreements where appropriate) will be initiated and executed by Noclor (on behalf of sponsor) to formally document the relationship between, and the responsibilities of, the sponsor and the party carrying out the research activities. 

Host site approval must be obtained prior to any activities commencing at a research site. 

For clinical trials, evidence of the executed contracts and host site approval are required as checklist items by Noclor prior to the sponsor issuing a study activation notice to the site.

 

Potential collaborators & third parties

The initial sourcing of third parties (and assessment of their viability) should be performed early on in the design and development of a study (during the work up of a funding application).

If a Noclor partner is being approached to sponsor a study the Chief Investigator will be asked to identify all potential collaborators, research sites and third parties at the sponsorship request stage. Prior to a decision on sponsorship being made Noclor will assess the following:

  • potential risks (studies involving multiple parties are more complex to manage)
  • cost implications
  • insurance and indemnity arrangements (ensuring full coverage)
  • proposed delegation of responsibilities to individual parties
  • which contracts and agreements may be required (utilising model agreements where possible)

 

Host research sites

In identifying research sites the Chief Investigator may want to consider :

  • where potential participants will be identified and recruited ?
  • whether Participant Identification Centres (PICs) will be used ?
  • whether any non-NHS sites will be involved ?
  • where other research activities aside from participant related research activities will take place – for example - where will study samples be for analysed ?

 

Host site approval (also known as NHS permission or R&D approval for NHS sites) must be obtained prior to any activities commencing at a research site.  Coordinated systems are in place across the UK for obtaining site-specific approvals.

The HRA website provides details on the current processes for gaining NHS permissions, non-NHS site and Participant Identification Centres (PICs) approvals and how to add new sites.  

Viability assessment of host sites 

The Chief Investigator should make the initial approach to a third party in regards to their proposed involvement in the study (for potential investigator sites this approach is usually made by the Chief Investigator to the intended Principal Investigator (PI)).

For clinical trials, a viability (feasibility) assessment should be documented on file (Study/Trial Master File (S/TMF)) for each third party approached (to evidence their subsequent selection or elimination).

The initial approach and feasibility assessment can be made via questionnaires (where the audit trail demonstrates information has been provided by the intended Investigator site/service provider).  Areas to consider when making an initial feasibility assessment of a research site are:

  • can the organisation identify the required number of potentially eligible participants to make setting up the site viable
  • are they running conflicting studies
  • is their standard treatment arm different to that of the clinical trial protocol (which would make the study unworkable)
  • does the PI have the relevant skills, expertise and time
  • does the organisation have all the appropriate facilities for the proposed activities on the study
  • if the site’s own equipment is to be used in the research is it fit for purpose ?

Facilities and equipment may be reviewed further (and records of calibration and maintenance may be requested) at a site visit as part of a site selection or initiation visit (if on the initial risk assessment it was deemed necessary to provide assurance to the sponsor that the facilities/equipment are fit for purpose).