Criteria for National Coordinators and host site organisations

1. Criteria for host site organisations

Organisations must meet the below criteria to be eligible to host a National Coordinator.

Criteria	Measure
The organisation is research active (commercial contract research)/ a leader in their speciality	The most research active organisations in the last 24 months, collectively representing a minimum of 80% of national commercial research activity and/or specialist hospital trusts. Based on data from NIHR CRN database.
The organisation is an active Chief Investigators (CI) host site for commercial contract research studies	The most CI active organisations in the last 24 months, collectively representing a minimum of 80% of national commercial research activity. Based on data from NIHR CRN database.

The list of organisations eligible to host National Coordinators will be reviewed every 12 months. Discretion will be exercised for organisations who have acted as a National Coordinator host site during the previous 12 months but no longer meet the criteria. If they continue to demonstrate adherence to the expectations of host sites and have competent and accredited National Coordinators and are willing, they will continue as National Coordinator host sites.

1.2 Expectations of National Coordinator host sites:

Organisations that meet the above criteria and wish to be a National Coordinator host site must commit and be accountable to adhering to the following expectations:

1. The organisation commits to nominating at least 1 National Coordinator (NC) from their organisation for the duration of their involvement as a host National Coordinator site. This is needed to maintain the minimum requirement.
2. The organisation commits to releasing time for their National Coordinators to undertake the role, training, accreditation and revalidation (where necessary),
3. The organisation commits to provide their NCs with the support and resources needed to meet the agreed timescale for completing the national contract value review and confirms they have the resource and capacity in which to do so,
4. The organisation commits to setting up and maintaining a group email account and NIHR CPMS account to be used for allocation of studies to NC(s) within their organisation,
5. Once allocated as the NC site for a study, the organisation commits to continuing to complete the national contract value review even if their organisation stops being a participating site,
6. The organisation will give NHS England and NHS Improvement and NIHR CRN at least 3 months’ notice if they wish to withdraw from being a National Coordinator host site.

2. Person specification for National Coordinators

Individuals who meet the following specification can be nominated by their organisation to be a National Coordinator and will be trained. Those individuals that then go on to meet the accreditation criteria will be formally accredited as National Coordinators.

Specification	Measure
Commercial contract research costing experience and/or resource allocation experience	Significant experience of; leading on commercial contract research budget generation, reviewing clinical / protocol resources requirements and procedures with clinical experts, and negotiation and/or resource allocating for commercial research
Experience of cost negotiation with commercial study sponsors/ Contract Research Organisations (CRO)	Significant experience negotiating with study sponsor/ CRO
Has the authority to act in national capacity endorsed by the Trust R&D leadership	Written confirmation from organisation/ R&D Director (by being nominated to be a National Coordinator)
Has the authority to access to clinical expertise (ideally Chief Investigator)	Written confirmation from organisation/ R&D Director (by being nominated to be a National Coordinator)
Has access to available study information and documentation. This may include: Full Protocol or Clinical Investigational Plan, Laboratory Manual, Radiology Manual, Pharmacy Manual, e-CRF and training needs	Written confirmation from organisation/ line manager (by being nominated to be a National Coordinator)

3. Accreditation

The purpose of accreditation is to demonstrate that after training, National Coordinators can
prove:

• Ability to differentiate national study wide resource and procedure requirements from local site requirements.
• In-depth understanding and knowledge of the National Contract Value Review, standard costing methodology and use of the NIHR interactive Costing Tool (iCT).
• Attention to detail demonstrated by accurately interpreting complex protocol requirements and translating into study resource and procedure requirements to support study costing.
• Accreditation will be completed online via NIHR Learn platform. Individuals will be allowed one retake to pass the accreditation. National Coordinators will be required to renew online accreditation every 12 months.

Accreditation will be completed online via NIHR Learn platform. Individuals will be allowed one retake to pass the accreditation. National Coordinators will be required to renew online accreditation every 12 months.

4. National Coordinator Standards

The National Contract Value Review should only be undertaken and validated by individuals who are accredited National Coordinators. The National Coordinator will be responsible for the quality assurance of the national contract value review, confirming the accuracy and completeness of the validated costing template based on the information available to them.

4.1 The National Coordinator role:

• To conduct the National Contract Value Review for studies assigned to them utilising the standard methodology provided through the NIHR interactive Costing Tool (iCT).
• To validate the national resource and procedure allocation required to deliver the study in England, generalisable to all sites, allowing participating sites to only focus on local site adjustments and individual contract negotiations.
• To ensure that appropriate ‘up front’ resource has been allocated to enable NHS departments within the sites to facilitate swift setup and continual maintenance of the study throughout its lifecycle.
• Proactively work with the Chief Investigator and/or Principle Investigators for the study and relevant clinical and service support expertise to determine appropriate resource requirements.
• Effectively validate all national costs associated with delivering a commercial research study and ensure full cost recovery for the study
  Facilitate initial communication/collaboration with the commercial sponsor regarding the National Contract Value Review process with support from the NIHR CRN.
• Escalates any areas of significant cost variation from standard cost methodology arising during a study review for swift resolution, for example a novel requirement or change in care provision.
• Supports the continual refinement of both the National Contract Value Review process and standard costing methodology.

4.2 Expectations of National Coordinators:

Competent, accredited National Coordinators must agree to commit and be accountable to the following expectations:

1. To meet the agreed timescale for completing the National Contract Value Review.
2. To ensure all relevant training and accreditation required for the role is completed and up to date.
3. To apply their commercial clinical research experience in the best interest of the NHS and patients.
4. To share best practice across the NHS and build peer support with other National Coordinators.
5. To act as an ambassador for the national contact value review process, standard costing methodology and iCT and communicate the NHS national costing approach effectively.
6. To maintain competence and accreditation by validating a minimum of 5 studies per year. National Coordinators who review less than 5 studies over a 12 month period will be expected to undertake a refresher course*

*The number of studies required for National Coordinators to maintain their competency will be reviewed during the first year of BAU and subject to revision based on learning from this operation.

4.3 Out of scope of the National Coordinator role

The National Coordinator, or their host site organisation, are NOT responsible for:

• A single point of contact to negotiate individual site localisation requirements with the commercial company following completion of the National Contract Value Review.
• Coordinating the execution of all contracts on behalf of all NHS providers involved in the study; each organisation remains responsible for executing their own contract with the commercial company.
• Any shortfall, perceived or real, in the prices negotiated through wor king to nationally agreed standards, process and tools (cost methodology and site agreements); any concerns with these should be raised via supportmystudy@nihr.ac.uk for the attention of NHSE, HRA and NIHR CRN and/or devolved administration network as applicable.