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Interventional Research



Set up of research activity at NHS organisations (interventional research)



The guidance on this page is split into the following sections:

Background and introduction

This guidance outlines the oversight arrangements that should be in place for an activity associated with an interventional research study, prior to that activity commencing. Specifically, it describes sponsor considerations for:
  • Determining whether an activity associated with an interventional research study should be overseen by a Principal Investigator (PI).
  • Whether such oversight may only be effective if provided by an individual employed by the organisation delivering the activity, or if effective oversight could be provided by a PI employed by another organisation.
The guidance provides advice on undertaking a risk assessment to support research sponsors in making these determinations. It also sets out expectations for aspects of study set-up that relate to these oversight considerations.

In describing activities that may be effectively overseen by a PI at a distance, as well as activities where No PI oversight required, the guidance is intended to help sponsors design and manage studies around the patient. For example, by ensuring that patients are not routinely required to travel to a distant research site when this is not necessary for the study.

The guidance provides principles and examples. It is not envisaged that the examples are exhaustive, nor that a sponsor should replace careful risk assessment of the specifics of their study with an ‘off the shelf’ solution. The examples are however intended to illustrate how a risk-based approach might apply the basic principles in specific scenarios. Additional information to assist in the adoption of the appropriate study set-up model is provided in the appendices. The guidance is a collaborative production between the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA), NHS Research Scotland, Health and Social Care Northern Ireland and Health and Care Research Wales.



Scope

Although the principles and examples set out within the guidance may have wider applicability, the principal scope is interventional heath care research in the NHS across the UK (throughout the guidance, NHS should be read to include Health and Social Care (HSC) in Northern Ireland). This includes primary care providers of NHS services, including where those services are provided by independent contractors (for example, General Practices), in England, Scotland or Wales. It excludes General Practices in Northern Ireland.

Interventional research comprises the following study types in the Integrated Research Application System (IRAS):

• Clinical trial of an investigational medicinal product (CTIMP)
• Clinical investigation or other study of a medical device
• Combined trial of an investigational medicinal product and an investigational medical device
• Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice


Complementary guidance is in preparation to cover the set-up of non-interventional studies in the NHS.


Principles

Trial Sites and Investigator Sites

The Medicines for Human Use (Clinical Trials) Regulations 2004 provide the following definitions, specifically for Clinical Trials of Investigational Medicinal Products (CTIMPs):

‘trial site’ means a hospital, health centre, surgery or other establishment or facility at or from which a clinical trial, or any part of such a trial, is conducted;’

‘investigator’ means, in relation to a clinical trial, the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team;’



Whilst ICH-GCP (E6(R2)) provides the following definitions, specifically for CTIMPs:

‘Trial site: The location(s) where trial-related activities are actually conducted.’

‘Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.’



As such, neither the legislation nor ICH-GCP require each establishment at which a trial, or part of a trial, is conducted, to have its own (Principal) Investigator.

Each 'Trial Site' (which, in this guidance we take to mean a legal entity responsible for some element of an interventional research study for which PI oversight is required) is not necessarily an 'Investigator Site' in its own right.



One Trial Site might consist of more than one Investigator Site (for example, an NHS organisation with multiple hospitals might, for a particular research study, need one Investigator Site for each of its hospitals). Equally, one Investigator Site might consist of more than one Trial Site (for example, research activities undertaken by multiple NHS organisations might be overseen by one PI). The ability for a PI to have effective oversight of research activities determines whether those activities come under that one PI and therefore one Investigator Site, or if an additional PI, and hence an additional Investigator Site, is required.

 

This guidance therefore adopts the term 'Investigator Site' to mean the activities (regardless of their location) with effective oversight by one Principal Investigator.



In this regard, this guidance applies these same CTIMP principles to all interventional research.

In addition, it should be noted that although the regulations state that where activity takes place at or from an organisation, it is a Trial Site, this applies only to activities that require PI oversight. For example, the analyses undertaken by central laboratories are not Trial Site activities but are instead contracted activities overseen by or on behalf of the sponsor.

Other activities may be associated with a research study but require neither oversight by a PI, nor contractual oversight from the sponsor. Simple blood draws undertaken by a suitably qualified individual at a general practice local to a participant, meaning that the participant does not need to travel to the trial site for that activity, are one such example.



Risk assessment to determine the appropriate level of PI oversight

A PI is the individual responsible for the conduct of a research study at an Investigator Site, which may comprise of one or more Trial Site. Where there is a team conducting that research study under that Investigator Site, the PI is responsible for selecting that team (by ensuring that they are appropriate for the role delegated to them, including by virtue of their education, training (external link) and experience) and also for the activities they undertake. Whether research activities performed at different locations are undertaken in one, two, or more Investigator Site is not determined by whether the locations are within the same legal entity, or are under the same management, nor by whether the personnel undertaking those activities share the same employer, but by the ability of each PI to effectively oversee the work being conducted at their Investigator Site.

Successful conduct of an interventional research study is dependent on appropriately trained and qualified staff. The PI for each Investigator Site is responsible not only for oversight of participants but also oversight of staff conducting activities in relation to the research study. The PI can delegate tasks within their team but must maintain appropriate oversight and control of the activities undertaken on their behalf and, in particular, of any issues regarding the research study that impact on participant safety or the results of the research study.

The PI needs to have pre-defined, clearly documented oversight and involvement in the research study – for example attending minuted meetings, taking part in medical decisions (for example, eligibility assessments, sign-off of SAE forms, involvement in the consent process). The PI needs to be available to the research team to answer questions and provide direction where required.

In order to determine the level of PI oversight and therefore how Investigator Site may be defined and managed, a risk assessment should be undertaken by the sponsor, that should include consideration of the following:
  1. IMP, device or other intervention type – for example, is it a licensed IMP being used in its licensed indication? Is there sufficient information on the safety profile?
  2. Research study design – what are the critical parameters? For example, does the PI need to know if the IMP or other intervention is not within the approved compliance window (as defined in the study protocol), or is the research study to look at what happens in the real world, and therefore this won’t affect the overall research study results?
  3. Central clinical review of the study design, for example. by the Chief Investigator (CI) and/or other clinicians with relevant expertise, to ensure that it will be feasible to deliver the study as designed in practice.
  4. Standard of Care – for example, would a surgical procedure at an organisation have occurred anyway, whether the patient is a trial participant or not; or if not, would it occur Within Usual Care Competence of the organisation?
  5. Is monitoring of the patients whilst taking the IMP part of usual care, for example standard blood tests for safety/efficacy monitoring?


Research studies should be designed and managed in light of the principles set out in this guidance. Specifically, the way that research activity is overseen, and different participating organisations managed, should be determined in the risk assessment for the research study. Good study design usually requires significant involvement from patient representatives. Studies should be designed around the patient.

Whilst it is the responsibility of the sponsor to undertake the risk assessment and to design the study accordingly, each PI remains responsible for the oversight that they are expected to provide. A PI should not accept oversight responsibilities unless they are confident in the arrangements made for the trial team and the infrastructure to support this approach.

Risk assessment is an ongoing activity and new risks may be identified. The assessment can be used to anticipate and mitigate new risks, guiding changes where needed, rather than a reactionary document. Of course, there may be circumstances in which unforeseen events require the sponsor to make modifications to their study (as has been the case during the COVID-19 pandemic). Where this is the case, the sponsor may make appropriate changes to their study delivery model, in keeping with the principles within this guidance and following a documented risk-assessment, either by substantial amendment or otherwise in keeping with requirements and expectations for amending research studies.

There are three levels of PI oversight that may be appropriate for a particular activity/set of activities, depending on the outcome of the risk assessment:

PI needed at the Trial Site

This is when the research activities to be undertaken by or at a Trial Site (that is, a legal entity) need a PI employed by that legal entity (substantively or by honorary contract), to ensure effective oversight. This means that the Investigator Site and Trial Site are identical, or that the Investigator Site is only a part of the Trial Site (in the latter case, for example, research activity is taking place in only one hospital in a larger NHS Trust/Board).

In most cases, where an organisation is recruiting participants and conducting the interventions (particularly for interventions that are not Within Usual Care Competence for that organisation or Standard of Care for that patient) that organisation should have its own PI, locally employed, to effectively oversee them.

For example:
  1. Activities not Within Usual Care Competence, such as protocol specific scans/observations relating to an unlicensed IMP or other protocol specific measurements/ assessments
  2. Administration of IMP not Within Usual Care Competence (or Within Usual Care Competence, but the risk assessment requires that this is done only at a Trial Site with its own PI)
  3. Accountability of IMP is required for overall evaluation of results
  4. Complex data collection and transfer - for example an electronic system for management of the IMP (such as an Interactive Response Technology; IRT), or use of participant recorded outcomes that may need support from the study team for training or use of an electronic device
  5. Data capture using systems that require monitoring - in general, this is likely to need to be performed under a locally employed PI, as the locally employed PI will be best placed to sign-off the CRF data, although risk assessment may conclude that a PI employed elsewhere and local sub-investigator may manage this by delegation and oversight. However, this approach would need to be clear in the monitoring plan and any modifications (i.e. additional Trial Sites that would need monitoring) would need to be tracked to ensure the approach was realistic.


Effective oversight from a PI at the Trial Site

The PI needs to have pre-defined, clearly documented oversight and involvement in the research study at the Trial Site – for example attending minuted meetings, taking part in medical decisions (for example, eligibility assessments, sign-off of SAE forms, involvement in the consent process). The PI needs to be available to the research team to answer questions and provide direction where required. Formal delegation of tasks needs to be undertaken by the PI for all site staff that are undertaking trial-specific tasks.



PI not needed at the Trial Site (PI oversight provided from elsewhere in Investigator Site)

Activities that require only some level of PI oversight can be undertaken at a Trial Site that does not employ (substantively or via honorary contract) the PI, under the delegation of a PI employed elsewhere. In such a circumstance, the Trial Site being overseen from a distance is part of the Investigator Site, as oversight of the activities is still required from a PI. A PI may oversee a number of Trial Site without being based in any of those locations. Alternatively, the PI at a Trial Site may also oversee one or more other Trial Site directly associated with their own Trial Site (which may be referred to as a hub and spoke approach).

Example tasks that may be undertaken by staff from a Trial Site with oversight from a PI employed elsewhere:
  1. Surgical, radiological or other interventions, or similar, that are Standard of Care or Within Usual Care Competence (but see 'No PI oversight required' below)
  2. Staff employed by an NHS organisation, that does not have its own PI, who visit participants at home to perform tasks Within Usual Care Competence, but are not Standard of Care
  3. Staff employed by a non-NHS third party provider who visit participants at home to perform tasks that are Within Usual Care Competence but are not Standard of Care
  4. Completion of a simple form to transfer data to the PI elsewhere
  5. Prescription and administration of the IMP, where this is licensed and part of Standard of Care, and no accountability is required. Note: If the IMP is unlicensed, and the risk is low, for example vaccine trials, and this approach is justified in the risk assessment, then this could be acceptable
  6. In some cases, randomisation may also fit under this example. For example, a participant may take part in a statin trial comparing 2 standard treatments – either of which could be prescribed by the GP as part of Standard of Care


Effective oversight from a PI not at the Trial Site:

Persons undertaking tasks as described above should be formally delegated them by the PI. This does not have to be an onerous task, for example the PI can delegate these tasks to a named sub-investigator at another location, who in turn can delegate tasks to their appropriately trained team/colleagues. The sub-investigator should keep a log of staff who can undertake these duties, but it does not need be authorised by the PI, as the PI will have confidence that the sub-investigator at that location will delegate to appropriate personnel. This is an example that has been routinely used for hospital pharmacy departments, where the PI has delegated pharmacy activities to the clinical trials pharmacist on the main delegation log and the clinical trial pharmacist then maintains a local pharmacy delegation log for the pharmacy staff.

In this example there must be a process to keep the PI informed of anything that could impact the conduct and delivery of the trial, particularly any safety or data integrity issues. This could be via contact with the PI and/or their team – for example telephone calls, emails, progress reports etc. There should be clear, simple instructions and associated forms for tasks and reporting information back to the PI. The sub-investigator should report any significant protocol deviations that may impact on patients’ safety or the overall trial results. Records of these interactions should be kept on file. However, the PI remains responsible for the conduct of the research study at a Trial Site, and evidence that effective oversight was provided is required. The PI is expected to be proactive and maintain regular contact with the Trial Sites for which they are responsible.



No PI oversight required

Activities that are part of Standard of Care, and that would be undertaken in the same way regardless of the patient taking part in a clinical trial, do not need to be overseen by a PI. In many cases this would also apply to activity Within Usual Care Competence. This would be the case where data can be shared with/retrieved by the PI, without the need for completion of a CRF by the other location. This approach should be justified in the trial risk assessment. As no PI oversight is needed, the activity need not take place within an Investigator Site.

For example:
  1. GP/HCP taking routine blood tests, or other measurements that are part of Standard of Care
  2. Blood (or other) tests taken at a GP, or satellite clinic or local hospital, that are Within Usual Care Competence of the Health Care Professionals (HCP) involved even if these are not part of Standard of Care (that is to say even if they would not be performed if the participant were not in the research study). This would include samples taken to send to a central laboratory using a trial-specific kit provided by the sponsor or directly to the participant.
  3. Identification of potential participants for a research study, who are then put in touch with the Investigator Site (no specific consent or recruitment takes place). Such activity may be PIC activity (or may be usual clinical referral) and does not constitute research activity requiring PI oversight
  4. Recording of visits and results in the patients’ medical records as part of Standard of Care; this would include treatment of a patient in hospital for example in an emergency setting, where the data is retrieved by the PI to ensure patient safety
  5. Staff who visit patients at home to provide Standard of Care, for example district nurses
  6. Activities that are performed in the usual way and under the usual competency of a contracted Service Provider, but would not be undertaken if the participant was not in the research study, for example PET scans undertaken on behalf of an Investigator Site by a third party that usually provides PET scans for the organisation as Standard of Care


Effective oversight where no PI oversight is required:

In these examples, oversight of the PI is not required as the patient is under Standard of Care, or the activities are Within Usual Care Competence and the risk assessment has determined that no PI oversight is required. Generally, the other location should have details of the research study and a contact number for the PI and sponsor if contact is required. What, if any, additional information should be provided to the location by or on behalf of the sponsor will be determined by the sponsor risk assessment. It is likely that for locations undertaking activities that are entirely Standard of Care, no further information would be required. More detailed instructions (such as for the correct processing and dispatch of samples) may be required for locations acting Within Usual Care Competence but not exactly as they would under Standard of Care.



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Summary of Principles and Expectations



Activity Oversight required Organisation type Local documentation expectations List in IRAS Agreement Assess Arrange

1. Activities not Within Usual Care Competence, such as protocol specific scans/observations relating to an unlicensed IMP or other protocol specific measurements/ assessments

PI needed at the Trial Site Investigator Site Investigator Site File Yes Site Agreement Yes: Full Yes: Full

2. Administration of IMP not Within Usual Care Competence (or Within Usual Care Competence, but the risk assessment requires that this is done only at a Trial Site with its own PI)

PI needed at the Trial Site Investigator Site Investigator Site File Yes Site Agreement Yes: Full Yes: Full

3. Accountability of IMP is required for overall evaluation of results

PI needed at the Trial Site Investigator Site Investigator Site File Yes Site Agreement Yes: Full Yes: Full

4. Complex data collection and transfer - for example an electronic system for management of the IMP (such as an Interactive Response Technology; IRT), or use of participant recorded outcomes that may need support from the study team for training or use of an electronic device

PI needed at the Trial Site Investigator Site Investigator Site File Yes Site Agreement Yes: Full Yes: Full

5. Data capture using systems that require monitoring - in general, this is likely to need to be performed under a locally employed PI, as the locally employed PI will be required to sign-off the CRF data, although risk assessment may conclude that a PI employed elsewhere and local sub-investigator may manage this by delegation and oversight

PI needed at the Trial Site Investigator Site Investigator Site File Yes Site Agreement Yes: Full Yes: Full

6. Surgical, radiological or other interventions, or similar, that are Standard of Care or Within Usual Care Competence

PI not needed at the Trial Site (PI oversight provided from elsewhere in Investigator Site Trial Site under an Investigator Site Records of e.g. instructions and associated forms for tasks; records of any information and interactions reported to the PI. Yes Hub and Spoke Agreement Yes: Minimal Yes: Minimal

7. Staff employed by an NHS organisation, that does not have its own PI, who visit participants at home to perform tasks Within Usual Care Competence, but are not Standard of Care

PI not needed at the Trial Site (PI oversight provided from elsewhere in Investigator Site Trial Site under an Investigator Site Records of e.g. instructions and associated forms for tasks; records of any information and interactions reported to the PI. Yes Hub and Spoke Agreement Yes: Minimal Yes: Minimal

8. Staff employed by a non-NHS third party provider who visit participants at home to perform tasks that are Within Usual Care Competence but are not Standard of Care

PI not needed at the Trial Site (PI oversight provided from elsewhere in Investigator Site Trial Site under an Investigator Site Records of e.g. instructions and associated forms for tasks; records of any information and interactions reported to the PI. No Hub and Spoke Agreement or similar arrangement between organisation employing (a) PI and the provider (sponsor may financially contract with provider, but the oversight must be provided by and documented for (a) PI) N/A (non-NHS) N/A (non-NHS)

9. Completion of a simple form to transfer data to the PI elsewhere

PI not needed at the Trial Site (PI oversight provided from elsewhere in Investigator Site Trial Site under an Investigator Site Records of e.g. instructions and associated forms for tasks; records of any information and interactions reported to the PI. Yes Hub and Spoke Agreement Yes: Minimal Yes: Minimal

10. Prescription and administration of the IMP, where this is licensed and part of Standard of Care, and no accountability is required. Note: If the IMP is unlicensed, and the risk is low, for example vaccine trials, and this approach is justified in the risk assessment, then this could be acceptable

PI not needed at the Trial Site (PI oversight provided from elsewhere in Investigator Site Trial Site under an Investigator Site Records of e.g. instructions and associated forms for tasks; records of any information and interactions reported to the PI. Yes Hub and Spoke Agreement Yes: Minimal Yes: Minimal

11. In some cases, randomisation may also fit under this example. For example, a participant may take part in a statin trial comparing 2 standard treatments – either of which could be prescribed by the GP as part of Standard of Care

PI not needed at the Trial Site (PI oversight provided from elsewhere in Investigator Site Trial Site under an Investigator Site Records of e.g. instructions and associated forms for tasks; records of any information and interactions reported to the PI. Yes Hub and Spoke Agreement Yes: Minimal Yes: Minimal

12. GP/HCP taking routine blood tests, or other measurements that are part of Standard of Care

No PI oversight required No Role in the Study No study-specific records need to be maintained No No study agreement No No

13. Blood (or other) tests taken at a GP, or satellite clinic or local hospital, that are Within Usual Care Competence of the Health Care Professionals (HCP) involved even if these are not part of Standard of Care (that is to say even if they would not be performed if the participant were not in the research study). This would include samples taken to send to a central laboratory using a trial-specific kit provided by the sponsor

No PI oversight required Organisation type Documentation to support sample collection, handling, and shipment

Organisations in England and Wales: No

Organisations in Scotland and Northern Ireland: Yes*

No study agreement No
No

14. Identification of potential participants for a research study, who are then put in touch with the Investigator Site (no specific consent or recruitment takes place). Such activity may be PIC activity (or may be usual clinical referral) and does not constitute research activity requiring PI oversight

No PI oversight required Participant Identification Centre (if PIC activity). No Role in the Study (if clinical referral) PICs: Records of e.g. eligibility criteria, participant-facing materials PICs in England and Wales: No

PICs in Scotland and Northern Ireland: Yes
PIC Agreement PICs Yes: Minimal PICs Yes: Minimal

15. Recording of visits and results in the patients’ medical records as part of Standard of Care; this would include treatment of a patient in hospital for example in an emergency setting, where the data is retrieved by the PI to ensure patient safety

No PI oversight required No Role in the Study No study-specific records need to be maintained No No study agreement No No

16. Staff who visit patients at home to provide Standard of Care, for example district nurses

No PI oversight required No Role in the Study No study-specific records need to be maintained No No study agreement No No

17. Activities that are performed in the usual way and under the usual competency of a contracted Service Provider, but would not be undertaken if the participant was not in the research study, for example PET scans undertaken on behalf of an Investigator Site by a third party that usually provides PET scans for the organisation as Standard of Care

No PI oversight required (assuming the scans are as per usual procedure – if not the likelihood is that PI oversight would be required) Service Provider Assuming that scans are performed as per usual, very little information required by the third party in addition to the usual information for Standard of Care. No Service contract No No


*Footnote (row 13) Currently national management systems in Scotland and Northern Ireland require details of all organisations involved in a study, whereas the systems in England and Wales do not. The intention is that with future developments, IRAS will be used to both record the organisations involved and grant access to study documentation to these organisations, aligning the process across all UK nations.

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Appendix 1: Clarifications



Clarification on Duty of Care vs. Physical Location

Organisations conducting research activity owe a duty of care to the participant (i.e. they are liable for harm arising from the conduct of their activity). The responsibility (and therefore liability) for the conduct of the research activity rests with the organisation that is undertaking the activity, regardless of the physical location where the activity occurs.

For example, a university may use facilities at an NHS organisation to conduct research activity with participants who are not under an NHS duty of care (for example, involving the use of clinic space or imaging equipment). If the university formally accepts liability for harm arising from the conduct of the research activity and indemnifies the NHS organisation against any loss arising from those activities, then the NHS organisation has No Role in the Study. It is likely that there will be a contract in place between the NHS organisation and the university to cover the use of the NHS organisation’s facilities and the indemnity arrangements. If the university does not formally accept liability (for example, in case of malfunction of imaging equipment), then the NHS organisation will be undertaking research activity and will have a role in the study that is dependent on the nature of activity, as described in this guidance.

It should be clear to participants, through study materials, such as the participant information sheets (PIS), study signage and verbal interactions, which organisation is taking responsibility for their participation in the study, for example, if the university is responsible for all research activity, the information should clearly state this and only use the university’s header and logo (that is to say, no NHS branding). If the university is not responsible for all research activity, or if it is not adequately clear to participants that the university is responsible, the NHS organisation should be considered as having a role in the study that is dependent on the nature of activity, as described in this guidance.



Clarification on inspections

The MHRA GCP inspectorate can inspect any organisation involved in a CTIMP, and in the future, any organisation involved in a clinical investigation or other study of a medical device which falls under the regulations. The MHRA may also undertake pharmacovigilance inspections in relation to Post Authorisation Safety Studies (PASS). In the context of this guidance, inspection will usually occur at Investigator Sites, or potentially at Trial Sites within an Investigator Site. The MHRA GCP inspectorate would only inspect other organisations involved in a research study if there is serious cause for concern in relation to the safety of participants or integrity of the data or in support of a marketing authorisation application.



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Appendix 2: Glossary



Other Participating Organisation

An Other Participating Organisation undertakes activities Within Usual Care Competence where No PI oversight required. As this activity will be in accordance with their usual competence, it will not require detailed instruction or oversight from a Principal Investigator. Generally, these organisations should have details of the research study, and a contact number for the PI and sponsor if contact is required, although more detailed instructions may be required in some cases.


Participant Identification Centre

A Participant Identification Centre (PIC) is an NHS organisation* that seeks to identify potential research participants for, or notify potential participants of, a research study taking place at another organisation in a way that creates a data controller/processor relationship between the sponsor and the PIC. A PIC processes personal data as specified by or on behalf of the sponsor and for the purpose of that sponsor’s study (e.g. undertaking a database search).

If the NHS organisation is not processing personal data for the purpose of the sponsor’s study (e.g. it is making a referral to a clinical trial primarily in the clinical interests of its patient(s), i.e. acting for its own purposes) or is not doing so under the instructions of a sponsor (e.g. it is simply contacting all registered patients to make them aware of research opportunities and hence not following detailed instructions in how to identify specific patients, or otherwise to process their data) no controller/processer relationship is established and the NHS organisation is not a PIC.

* Footnote for Participant Identification Centre: The definition of PICs is deliberately limited to NHS organisations (including primary care independent contractors). Whilst non NHS/HSC organisations may undertake PIC-style activity, they are outside the remit of this guidance. Non-NHS organisations may choose to have regard to this guidance but are not bound by it.


Service Provider

A Service Provider is a third-party organisation that provides a service (e.g. undertaking scans, surgical procedures, laboratory analysis) to another organisation or the sponsor under a Service contract. A Service Provider may undertake activity Within Usual Care Competence or Standard of Care activity as part of a research study. If the activities undertaken by the Service Provider are performed as usual, then No PI oversight required. However, if the activities are not performed as usual, then it is likely that PI oversight will be required (in keeping with the outcome of a risk assessment of the extent of the deviation from usual practice and hence the need for PI oversight) and the organisation undertaking those activities will either be part of an Investigator Site or an Investigator Site in its own right and hence excluded from the definition of Service Provider as used in this guidance.


No Role in the Study

Where an organisation is not expected to take responsibility for or do anything beyond what it would do under Standard of Care it has No Role in the Study. The organisation retains its normal duty of care, where applicable, for these Standard of Care activities.


Within Usual Care Competence

An activity that an organisation is competent to undertake (through current staff experience/training and facilities), but the activity would not happen in quite the same way and/or at the same point in the care pathway if the research study was not taking place.


Standard of Care

An activity which would happen in the same way and at the same point in the care pathway even if there was no research study taking place.


Site Agreement

An Investigator Site requires a Site Agreement to be in place between the Investigator Site and the sponsor to make the responsibilities of each organisation clear. If research funding is offered, and the Investigator Site wishes to receive this funding, the agreement should also include a finance schedule. Examples (external link) of Site Agreements for commercially sponsored studies include: the model Clinical Trial Agreement (mCTA) and the model Clinical Investigation Agreement (mCIA). The model Non-Commercial Agreement (mNCA) should be used to contract NHS sites non-commercially sponsored interventional studies (other than Phase I healthy volunteer CTIMPs).

GDPR Article 28(3) states:

‘Processing by a processor shall be governed by a contract or other legal act under Union or Member State law, that is binding on the processor with regard to the controller.’



As an Investigator Site will always process personal data in a way that creates a data controller/processor relationship between the sponsor and the Investigator Site, the various model site agreements (mCTA, mNCA, etc.) each include GDPR Article 28(3) data processing clauses.


Hub and Spoke Agreement

Where an Investigator Site comprises of more than one legal entity, there should be agreements in place between the Trial Site that comprise the Investigator Site (this would usually take the form of a Hub and Spoke Agreement, or set of agreements). These agreements should set out the expectations of the parties and the arrangements for the oversight of activities by the PI. It is likely that Trial Sites within an Investigator Site will require data processing agreements between them, specific to the study, to ensure that the obligations placed by the sponsor on one entity within the Investigator Site flow down to the other organisations (that will be processing personal data at the instruction of the sponsor).


PIC Agreement

As a Participant Identification Centre (PIC) is an NHS organisation processing personal data in a way that creates a data controller/processor relationship between the sponsor and the PIC, there must be an agreement in place that includes data processing clauses to comply with GDPR. The model PIC agreements (external link) incorporate data processing clauses. Note that these are sub-processing agreements, so would not be appropriate if the sponsor (data controller) wished to contract directly with the PICs on the study.


Service contract

A Service contract sets out the terms and conditions under which a Service Provider is engaged. Where a Service Provider is involved in a research study, and the activities are performed as usual, this may be covered under an existing Service contract. It should be ensured that the Service contract covers the activities being undertaken.

If the activities for are not being performed as usual, then it is likely that PI oversight will be required (dependent upon risk assessment of the level of deviation from usual practice and the consequential need for PI oversight). Activities requiring PI oversight are excluded from the definition of Service Provider used in this guidance, so any existing Service contract will not cover the activities. A Site Agreement or Hub and Spoke Agreement should be used as appropriate instead to cover the activities.

If PI oversight is not required for Service Provider activities that are not covered by an existing Service contract, a Service contract may be put in place for the specific research study or situation. This Service contract should cover the primacy of the trial protocol and the appropriate standards required to be followed, e.g. compliance with the Clinical Trial Regulations for CTIMPs, and relevant guidance.

If the sponsor is a party to the Service contract, the sponsor is responsible for ensuring that it covers the activities being undertaken. If the sponsor is not party to the Service contract, then the sponsor should take proportionate assurance from the organisation that does hold the Service contract with the Service Provider that it covers the activities; the sponsor should not normally need to have sight of the Service contract, which may contain confidential information.


Assessing and arranging capacity and capability

Full

In terms of the ‘assess’ and ‘arrange’ steps of assessing, arranging and confirming capacity and capability, it is expected that the organisation will need to fully consider the implications of participating in the study and put specific arrangements in place to be able to undertake their activities.

Minimal

In terms of the ‘assess’ and ‘arrange’ steps of assessing, arranging and confirming capacity and capability, it is expected to be relatively straightforward for organisations to consider the implications of participating in the study, and that minimal arrangements would need to be in place to be able to undertake the activities: for example, ‘do we have the staff/resources to undertake the activities?’, ‘do we hold the data being requested?’, ‘will the systems in place locally make it easy or difficult to undertake the activities?’ (for example, accessing electronic vs. hard copy records).



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Page last updated: 10 November 2021

 



 
IRAS Integrated Research Application System, version 5.21, 14/09/2021, IRAS Dataset version 3.5.
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