Assess arrange and confirm capacity and capability

Area

Things to consider

Specific questions to ask

Suitable Investigator & Site Personal identified The Ready for Review and HRA Approval letters will confirm if a Principal Investigator (PI), a Local Collaborator or neither is required at participating organisations. Where a PI is required, the participating organisation has identified a suitable investigator.

‘Suitable’ defined as a named investigator taking into account his/her professional qualification, knowledge of research field, expertise in the procedures involved, previous research experience, training in research methods (including informed consent), training in Good Clinical Practice (if applicable) and ability to take clinical responsibility for local research team.

Do you have suitable staff who can give enough time to the study; can they be released to work on the study? Are they engaged and interested in the research? Do they have the required skills?

Has a suitable and willing PI been appointed (from the practice team?)

Conflict of Interest

Any personal involvement of site personnel with the sponsor or funder have been declared

Do any of the staff have any conflicts e.g. with other roles, personal relationships?

Study Follow-up

The clinical research staff or participating organisation have the capacity to support all study follow up as required

Are you aware of the extent of follow-up activity – will there be ongoing commitments after recruitment? (e.g. follow up appointments, data from the clinical system)

GCP Training

All staff that require GCP training have accredited/appropriate training eg NIHR or similar standard

Have the staff had GCP or other required training?

Appropriate Equipment available

Study specific equipment is on site or being provided by sponsor

Does the study require any specific equipment and does the practice have this available?

Safety

The requirements for reporting to the sponsor on progress and pharmacovigilance

Do you understand what reporting is required?

Local arrangements for handling of Investigational Medicinal Product (IMP)

Are there specific considerations for handling the Investigational Medicinal Product?

Local Informed consent needs

Obtaining consent in accordance with the study protocol while considering the needs of participants who may not adequately understand verbal explanations or information written in English

Are there any concerns about your population engaging with the informed consent process, e.g. language needs. Any translated versions required are the responsibility of the study team.

Training

The participating organisation can accommodate training format required by the Sponsor e.g. online, face to face or routine briefings within the specified time frame required by the Sponsor

Do you know what site initiation/training will be provided by the study team and are you able to accommodate this? (e.g. consider timing, face to face vs virtual).

HR

Local Human resource requirements to ensure that staff only undertake study specific activities that are appropriate to the job and competencies of the individual, and that appropriate supervision will be provided as required. This may include arrangements to issue letters of access or an Honorary contract where participants will be seen by non-NHS Organisation employees

Have you reviewed the study and ensured that the staff working on the study meet the study requirements (e.g. qualified doctor, nurse, prescriber)?

Are there any external staff involved in the study at the practice – these should be referred to West Yorkshire R&D for a letter of access.

Recruitment Target

Based on the projected study timelines there are sufficient numbers of potential participants meeting the inclusion/exclusion criteria when taking into account any competing trials currently open or planned to open at the participating organisation to minimise the potential for inadequate patient recruitment or non-completion of research

How many participants does the study wish to recruit from the practice? Do you have enough eligible patients (bearing in mind that you will not manage to get every eligible patient to agree to take part)?
Are there other studies which would be seeking to recruit the same participants? Could this be a potential conflict?

Suitability of site

Suitability of participating organisation facilities including; adequacy of facilities for any novel procedures or for procedures not part of existing clinical activity; availability and access to resources, facilities, equipment and storage considering impact on current levels of use for non-research activities; and considering Sponsor quality expectations. Availability of work space for sponsor team monitoring if required

If being asked to undertake activities which are not part of standard clinical practice, are your rooms/facilities/equipment suitable? Do you have enough space/equipment so that taking part in the research will not impact on delivery of standard care?

Indemnity

The HRA ensures that the sponsor has appropriate insurance for the design and management of the research. It is then a sponsor responsibility to assure itself that each individual site has appropriate insurance for the delivery of the research. For NHS sites, this is inherent and derived from NHS Litigation Authority. For non NHS sites and independent contractors, acting as a site, they will need to arrange suitable indemnity themselves, which should be reviewed and deemed appropriate by the sponsor.

General practices’ delivery of research is now covered by CNSGP (https://www.hra.nhs.uk/planning-and-improving-research/best-practice/nhs-site-set-up-in-england/frequently-asked-questions-about-research/)

Financial arrangements

The financial arrangements applicable to the participating organisation are adequately described, i.e. the practice has full information/confirmation about which organisations will be paying for which costs. Any costs that the practice incurs should be covered by one of the following:

• Service support costs are paid by the CRN, so the practice may wish to see the confirmation that these costs are covered (this may be included in the site/PIC agreement)

• Research costs are paid by the study, so should be detailed in the site/PIC agreement

• Excess treatment costs are paid under national arrangements – see guidance for details

Internal arrangements

Suitable arrangements for permissions/peripheral clinics/access when study involves NHS patients external to the participating organisation (e.g. another NHS Organisation)

Emergency procedures

Emergency procedures that may be necessary are conducted at the participating organisation in accordance with the protocol (e.g. to protect the participant in the event of a life-threatening incident or adverse event)

Local Contact information

Where applicable the participant is clear about the local address and telephone number (usually included in the patient information), additionally contact details of the local investigator(s), and if applicable, other members of the research team, e.g. research nurses, Emergency contact information, if appropriate, contact information for complaints and, where appropriate, independent advisors.

Archiving and storage arrangements

Storage of data during the study and any post study archiving arrangements

HRA guidance

The HRA Approved protocol and any guidance provided in the HRA Approval letter are adhered to. This includes, but is not limited to, any patient consent, Information Governance, Human Tissue Act, and Mental Capacity Act arrangements. Radiation The Ionising Radiation (Medical Exposure) Regulations and the Medicines (Administration of Radioactive Substances) Regulations

Fraud and Misconduct

Local systems in place for dealing with fraud and misconduct

Involvement

HRA letter wording

What the practice must do

PIC

The HRA letter details the type of agreement the study is using. For a PIC, the HRA recommends that the model PIC agreement is used. This agreement is made between the practice and the site where the research activity is taking place.

No formal confirmation required

This is usually only for studies with minimal 'ask' for practices, or urgent public health studies where it is expected that all practices will participate.

The research can proceed without agreement from the practice, after the length of time detailed in the HRA letter (in this example seven days).

It is subject to the following conditions (as well as any others detailed in the letter):

• HRA approval has been received

• Practices have been notified about the study

• Practices can also object or request more time to consider their participation.

If a practice does not wish to participate, they must give the sponsor a reason.

If a practice positively confirms they can participate, then the study can proceed earlier than the stated length of time.

Guidance can be read here: Where no C&C is required.

Practices required to formally assess, arrange and confirm their participation

The letter should also detail the method by which the practice will confirm C&C.

Formal written confirmation must happen before any research activity can take place.

This doesn’t mean wet ink signed contracts – in many cases a simple email will be acceptable as confirmation.

An authorised member of staff from the practice should check through the Localised Organisation Information Document (OID). This should detail what is required by the study, and all of the fields marked with a * should be completed by the study team, outlining the requirements. This should include start and finish dates, recruitment target, equipment and training requirements. The appendices detail any financial provisions, how materials will be shared and data processing/sharing arrangements.

Items marked with a ^ are to be completed by the practice; then the OID should be returned by email from an authorised signatory (wet ink signatures are not expected).

The Local OID is not a final document presented to the practice, but is to be negotiated and agreed between the practice and the study. Here is where you can agree targets, finances and local arrangements.

Unmodified agreements have been negotiated and reviewed by legal teams centrally, so practices can be assured that they can sign up to these, provided they have reviewed and agree to the study detail in the appendices.

The PIC agreement is appropriate when acting as a Participant Identification Centre (PIC) [see Understanding the role of PICs guide]. It is an agreement between the practice and the research site (often a hospital trust).

The person signing the agreement must be an appropriately delegated member of staff from the practice.

An electronic signature will often be acceptable with agreement from the Sponsor.

The signed copy should be kept in the site file (either hard copy or electronic)

It should be specified in the HRA letter where the Sponsor has used a modified or bespoke agreement.

Where non-standard/modified agreements are used, the practice may wish to seek legal advice, but at the very least should carefully check through the agreement terms to make sure they are happy with these.

When different parts of the study are mentioned, the practice should confirm which parts of the study are applicable to them.

The detail should be found in the OID, but if not sure you should clarify with the study team and receive confirmation in writing where possible.