NIHR CRN Recruitment Policy Document

Introduction

The purpose of this document is to set out the NIHR Clinical Research Network’s policies governing the collection of recruitment data relating to studies eligible for NIHR Clinical Research Network (NIHR CRN) support. It therefore relates only to England.

Please use the following link to see Details of the aims and purpose of the NIHR Clinical Research Network.

The main role of the NIHR CRN is to provide infrastructure support for the initiation and delivery of high quality research which benefits patients and the NHS, including relevant research in public health and social care. This includes randomised controlled clinical trials of interventions (e.g. prevention, diagnosis, treatment and care studies) and other well-designed research.

This document must not be interpreted as regulatory, ethical or legal advice, but as guidance solely in the context of recruitment data used for NIHR CRN purposes.

Policy Statements

NIHR-wide agreed definition of recruitment

1.1. Recruitment is the enrolment of an individual person meeting specific inclusion criteria into a research study. Each study participant who has both provided informed consent to join a study and is taking part in the study (i.e. participants who count towards the sample size of the study as set out in the study protocol), should be recorded as a participant in our NIHR Central Portfolio Management System (CPMS).

Purpose of collecting recruitment data

2.1. The key purpose of the NIHR Clinical Research Network (CRN) is to ensure the effective provision of research infrastructure / NHS service support so that more clinicians can contribute to clinical research and so that more patients and organisations can benefit from being part of a research study. Recruitment data is a key part of the information used to monitor and improve the work of the CRN. This data also feeds into the process of allocating future funding to the NIHR Local Clinical Research Networks (Local CRNs, or LCRNs) to ensure that infrastructure / NHS service support are directed to where they are required.

Nature of recruitment data

3.1. Recruitment data may relate to the following (not an exhaustive list):

• Patients recruited to a treatment regime

• Staff members who have completed a questionnaire(s) or been interviewed in research

• Individual members of focus groups

• The collection of tissue or blood samples during research

• Participants who have answered questions during research

3.2.  In each of these situations a line of data should be provided for each recruit that has consented to participate during the study.

3.3. Where a recruitment event occurs twice in the same study (e.g. a participant completes two questionnaires, or provides multiple consents for different phases of the study) or a sample is tested twice, the recruitment is only counted once.

3.4. Recruitment data is required from the date the study is deemed eligible for CRN support (i.e. the date of the eligibility decision in CPMS) and relevant Capacity and Capability approval has been given for the site. The study team and/or Lead LCRN should liaise with the Research Delivery team in the CRN Coordinating Centre to set an appropriate sample size to reflect the planned recruitment period. This is to enable effective performance monitoring. If there is a valid reason for uploading retrospective data this will be assessed by the Research Delivery team on a case by case basis.

Timeliness of recruitment data

4.1. Local research teams should be encouraged to record research activity data in LPMS as soon as possible after the event has occurred i.e. in ‘real time’. However, if this is not possible there should be a minimum expectation that research activity held in LPMS should be updated weekly.

4.2. For studies that upload a spreadsheet to CPMS, study teams are asked to complete this at the start of each calendar month.

Recruitment site (i.e. for the purposes of recording recruitment data)

5.1. The site where the participant is consented should be listed as the recruitment site.

5.2. Recruitment should be recorded using the site-specific code (e.g. hospital code, GP surgery code) and not a Parent Organisation code (unless an exception described in paragraph 12.4 or 12.5 applies).

Transfer of recruitment data information to NIHR CRN

6.1. You are able to pass this information to the NIHR CRN. Security of information pertaining to participants recruited to CRN Portfolio studies is extremely important to us. The fields on the CPMS upload spreadsheet and transferred from LPMS to CPMS only collect non-identifiable information. We also ask that the Unique Participant ID is not a hospital or NHS number or any other type of data that could identify an individual participant. None of the data required, therefore, should directly identify the participant. We do not publish the detailed recruitment data you provide to us; only total numbers of study participants are made publicly available. There are no Information Governance or GDPR issues associated with providing research activity data to the CRN.

Research programmes, studies and sub-studies

7.1. For the purposes of the CRN Portfolio, a study is generally defined as a structured research activity which is the subject of a single IRAS and ethics application resulting in HRA approval. Therefore, if the research question being addressed in a sub-study (by which we may also include follow-on studies, or nested studies) is covered by the same ethics approval which covers the main study, the sub-study would not usually be viewed as a study in its own right and recruitment would not be submitted separately for this study as it will already be being collected for the main study.

7.2. However, if the sub-study is the subject of a separate IRAS application and HRA approval and participants who have previously consented into the main study are required to additionally consent into the sub-study, then the sub-study would be considered as a study in its own right. The sub-study would need to be assessed against the Eligibility Criteria for NIHR CRN Support as a separate study and would report recruitment separately. A sub-study approved via a substantial amendment to a main study as opposed to via a new IRAS application would not usually be viewed as a separate study in its own right.

7.3. However, if the sub-study has been awarded additional/separate funding to the previous main study it may be referred to the CRN Portfolio Eligibility Team to be considered as a separate study, provided the following conditions are also met:

• The sub-study is addressing a primary outcome additional to that defined in the main study;

• The sub-study involves a separate consent to the main study (which may apply to the same or different participants to the main study)

• The sub-study requires significant additional/different support from the CRN to the main study

• The study meets the Department of Health and Social Care's Eligibility Criteria for NIHR CRN Support. (This includes confirmation that the sub-study is of clear value to the NHS, that it takes appropriate account of the priorities, needs and realities for the NHS, and that it meets the definition of a ‘research study’)

Note: Research can be defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound 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. 

7.4. Please be aware that it is not possible to submit a substantial amendment for a study which has closed to recruitment and under these circumstances a new IRAS application would be required. In instances where the CRN is asked to list a study as ‘suspended’ pending a substantial amendment, it will use the criteria described above to consider whether a separate study record would be more appropriate.

7.5. A request for a sub-study to be considered for inclusion in the CRN Portfolio must be submitted to the CRN Coordinating Centre before it opens to recruitment.

7.6. Researchers are advised not to assume that submitting a new sub-study (or similar) as a substantial amendment for an existing study is a simpler or faster route into the CRN Portfolio. Such sub-studies may not be accepted as separate studies and therefore may not be permitted to upload recruitment data. The standard application process via Health Research Authority (HRA) Approval has been significantly improved and streamlined, such that it now tends to be non-standard applications, such as those submitted as substantial amendments, that take longer and more effort to resolve.

Recruitment data from Devolved Nations and other countries

8.1. Data for participants recruited in the Devolved Nations (Scotland, Wales and Northern Ireland) should be included. CPMS will allocate data to the appropriate Clinical Research Networks (or Devolved Nation equivalent) for resource allocation purposes. Recruits from outside the UK³ should not have a row of data listed (but can be recorded in the ‘Non-UK recruitment’ field in the CPMS study record).

Note: In the context of this paper, UK refers to England, Scotland, Wales and Northern Ireland but excludes the Channel Islands and the Isle of Man.

Research activities across different locations

9.1. The site where the participant is consented should be listed as the recruitment site. This is on the assumption that, in general, the site where the patient is consented is the research site where most of the NHS infrastructure support is required.

9.2. CPMS is able to record a number of Site Activity Types (including Participant Identification Site, Recruitment Site, Shared Care Site and Follow Up Site) enabling the roles that different organisations undertake to support a study to be captured.

Parent Organisation

10.1. In the context of CPMS, this is the organisation with which the research site is associated, to allow correct attribution of the Research Activity for the purposes of funding allocations and reporting. Parent Organisations include:

• NHS Trusts
• GP Practices (England only)
• Scottish Regional Health Boards
• Welsh University Health Boards
• Northern Ireland Health and Social Care Trusts

Recruitment from NHS and non-NHS sites

11.1. The main role of the NIHR CRN is to provide infrastructure support for the initiation and delivery of high quality research which benefits patients and the NHS, including relevant research in public health and social care.

11.2. All portfolio studies that meet the NIHR definition of recruitment should report all UK recruitment as lines of data in the recruitment upload.

11.3. The site of recruitment should be reported as the location where consent to enter the study was taken. Recruitment sites are then mapped to the Parent Organisations and Local CRNs providing support at those sites.

11.4. Recruitment from a non-NHS site in the UK that has not involved NHS staff and/or resources at that site (e.g. care being funded by NHS) will be recorded as ‘Non-NHS activity in local research area’ and then mapped to the relevant Local CRN.

11.5. The above arrangements will enable the identification and therefore monitoring of studies that recruit from a mixture of NHS and non-NHS settings and will ensure that these studies are not disadvantaged in terms of measuring delivery to time and target.

Use of Parent Organisations (Trusts, Integrated Care Boards (ICBs)) as recruitment sites

12.1. The site of recruitment should be reported as the location where consent to enter the study was taken. Recruitment sites are linked to the Parent Organisations and Local CRNs providing support at those sites.

12.2. If there is NHS involvement it is important to choose an NHS Parent Organisation wherever possible, as this supports the accurate attribution of activity for performance management and funding purposes.

12.3. Recruitment site mapping uses ODS codes. All NHS and many non-NHS sites have ODS codes (including many schools, prisons, care homes, etc) and so for the vast majority of studies the correct recruitment site should be available to select from the site list available in CPMS.

12.4. For a small number of studies the site of consent may be unknown or confidential, or cannot be coded (e.g. home visits). In these instances we would choose the NHS site or Parent Organisation that is supporting recruitment, since we are unable to select the actual location of consent. If there is no NHS involvement at an unknown or uncodeable site of consent, we will record this as non-NHS recruitment within the relevant Local CRN or devolved administration.

12.5. In some instances, a team working across multiple locations may have been assigned its own ODS site code, e.g. Community Mental Health Teams. If consent was taken at a location that is unknown or cannot be coded, or at a location that has a site code but it is linked to the wrong Parent Organisation, the ODS code for the team carrying out the recruitment can be used.

12.6. For studies with an online consent process, research activity data should not be mapped to the lead organisation (e.g. NHS site, Higher Education Institution) but to the geographical region or the LCRN in which the activity/ participant is based. Recruitment shall therefore be allocated to “Non-NHS Site in [LCRN]” as a site. This is to allow the CRN to record the true geographical reach of the study. The CRN is required by the DHSC to offer the opportunity to take part in research across the country and to improve inclusion of people from under-served groups, and recording of participation by geographic region supports this. Online consent requires minimal support/resources, and therefore, mapping geographically does not negatively impact the lead NHS site.

The research activity data for studies with online consent is managed and collected by a central study team. As an ‘exception study’, research activity data should be uploaded by the study team via the manual upload route. It is, therefore, the study team’s responsibility to map the participants to the correct LCRN. Through the “Plan your study” service, study teams collecting participants’ postcodes, should be made aware of this process. Postcode information is collected by the study team along with other participant data and is not shared with the NIHR CRN.

The lead LCRN offers support by providing a list of UK postcodes (updated every quarter) which is mapped to the respective LCRNs as well as the associated site codes to be used for the manual recruitment upload. If postcode data is not collected, further options will need to be explored as part of the Early Contact and Engagement Service.

12.7. The following examples are provided to help illustrate site-mapping decisions for some less common scenarios:

1. Example 1: Site of consent cannot be coded. NHS involvement.
   • NHS staff from Abbey Grange Medical Practice consent patients via home visits. Personal home addresses cannot be assigned ODS codes, therefore recruitment should be recorded under Abbey Grange Medical Practice (recruitment site), which has a fixed relationship linking it to NHS Leeds West CCG (Parent Organisation).
2. Example 2: Consent taken by Ambulance staff. NHS involvement.
   • NHS Paramedics from Bolton Ambulance Station are called out to a patient whom they consent before transferring them to hospital.
     • If the consent was taken at a location with an NHS site code linked to the correct Ambulance trust, or at an unlinked site (such as a prison, care home or school), recruitment should be recorded against that site code and linked to North West Ambulance Service NHS Trust.
     • If the consent was taken at a location that is:
       • unknown, or
       • cannot be coded (e.g. in an ambulance in between the incident location and the hospital, or at a participant’s home), or
       • at a location that has a site code but it is linked to the wrong Parent Organisation (e.g. a care home already linked to a ICB from a previous study),
       recruitment should be recorded using an appropriate site code for the ambulance staff employer, in this example North West Ambulance Service (main address/location as the recruitment site), which has a fixed relationship linking it to North West Ambulance Service NHS Trust (Parent Organisation). If the site has no code, please check if there is another relevant site code for the correct Parent Organisation that can be used. If no appropriate site code can be identified please liaise with the Local CRN to review if a new site code should be created or if in this instance the code related to the Ambulance Trust should be used.

• Example 3: Site of consent unknown. NHS involvement.
  • Leeds and York Partnership NHS Foundation Trust staff are supporting the recruitment of individuals at high risk of suicide. Due to confidentiality issues the staff recording the recruitment data are not made aware of the site at which participants consented, therefore recruitment should be recorded against the Trust acting as a site (recruitment site), which will then be automatically linked to itself i.e. Leeds and York Partnership NHS FT (Parent Organisation).
• Example 4: Site of consent cannot be coded/unknown. No NHS involvement.
  • A research organisation is recruiting participants at an unknown or uncoded site. There is no NHS involvement. Recruitment should be recorded using the generic non-NHS activity site code for the relevant Local CRN or devolved administration (available on request via the central BI Team).

In order to find the most appropriate code for the recruitment site please use the Site Search tab within the Find a Clinical Research Study app on the Public ODP environment.

Shared recruitment arrangements

13.1. We appreciate that sites and staff from different organisations need to work together to enable a participant to take part in a research study. For example, a patient may be identified at one organisation (a Patient Identification Centre, or PIC) and referred to another site for consent, treatment and/or follow-up. In such cases recognition or reimbursement for this effort should not be provided by sharing recruitment data with a non-consenting site but through other local arrangements with your Local CRN.

13.2. CPMS is able to record a number of Site Activity Types (including Participant Identification Site, Recruitment Site, Shared Care Site and Follow Up Site) enabling the roles that different organisations undertake to support a study to be captured. Participant-level data relating to research activities other than taking consent (for example, participant identification or follow-up) should be entered into your LPMS, so that it can be recognised and supported by the Local CRN.

13.3. In terms of the upload/transfer of recruitment data to CPMS, we only require information on the site at which consent was taken for participants that meet the recruitment definition (see paragraph 1.1). Where it is available in LPMS, we will also transfer data regarding consents (where recruitment may not yet have been confirmed) and screen failures. This is primarily used to inform our national reporting to the Department of Health and Social Care, but is also used in many other reports used by our partner organisations as well, e.g. 4 feasibility intelligence, planning decisions, information requests, research communications, etc. Therefore, if data is incorrectly recorded against the wrong sites, or against the wrong site type, it may have detrimental effects which can potentially affect a wider audience.

13.4. PIC participation in research, and therefore recognition of PIC activity, should be recorded by marking the PIC as a 'patient identification centre' under the 'site type', and listing the PIC as a 'final site' on CPMS, where the undertaking of patient identification activity can be confirmed.

Note: from October 2018 CPMS data has been used to trigger Excess Treatment Cost (ETC) payments to NHS organisations. ETCs will be paid to the recruiting site so any anomaly in the recording of recruitment activity, such as recording recruitment against PICs, will trigger an ETC payment to that organisation.

Use of department-specific ODS codes

14.1. When selecting a site to record recruitment data against, please select the site name and code relating to the main hospital/organisation as opposed to specific wards or departments within it. Such detail is not required by CPMS and can cause complications in our recruitment reports.

Correct code management in the event of organisational changes (e.g. mergers)

15.1. CPMS receives site and Parent Organisation data directly from the ODS (Organisation Data Service) which is maintained by NHS Digital. This includes the codes and names which are displayed in CPMS. For secondary care sites, the relationships between sites and parent organisations are also defined and cannot be amended. These are maintained by an OC1 contact per trust.

15.2. Research activity needs to be recorded against the relevant recruitment site code (which has a relationship to the correct parent organisation on the study record) within the site's start and end dates. As research activity uploads are validated against site start and end dates, if activity is not assigned correctly, this will fail to be uploaded to CPMS.

15.3. There are cases when sites will close due to their Parent Organisation closing i.e. when NHS secondary care trusts close and/or merge with another secondary care trust, the sites which they have relationships with as specified in ODS will also close. A new site code linked to the new NHS secondary care trust will be made available for use. If there is ongoing activity after the end 5 date of the original site, the new site (linked to the new trust) will need to be added to the study record and activity from the date of the new site's start date attributed to the new site.

Note: If you require help finding the correct code please contact the Lead Local CRN for support.

Example:

A study opens at Heartlands Hospital (part of the Heart of England NHS Foundation Trust) on January 1 2017. The site code is RR101 and research activity is recorded against this code.

On March 31 2018 Heart of England NHS Foundation Trust closes along with all sites which are associated with it. Services are transferred to University Hospitals Birmingham NHS Foundation Trust. The site code RR101 now has a closure date of 31st March 2018 and should not be used for any future research activity.

A new code is released by ODS for Heartlands Hospital under University Hospitals Birmingham NHS Foundation Trust - RRK97. This site has a start date of 1st April 2018 and so all research activity from this date should be recorded at RRK97. Activity prior to this should remain at RR101.

15.4. Please note, we depend on data being released by ODS in order to populate CPMS. This means there can be delays in the release of new site codes.

15.5. Ensuring activity is correctly attributed at site level will enable accurate reporting for the wide range of organisations that rely on this data, and correct financial calculations e.g. Excess Treatment Cost payments. If you need support selecting the correct site code please contact the Lead LCRN.

Research information relating to organisations

16.1. Where a study involves individuals, e.g. interviews with GP Practice Managers/NHS staff to research the outcomes of changes to the pattern of service delivery, then each individual who takes part in the study should be recorded as a single recruitment. If however, the study is pitched at the level of whole organisations and does not involve individuals in any way, then the number of organisations (e.g. GP practices) which are contributing in some way to the study should be reported as the recruitment. This situation may arise in cluster randomised studies, and/or research questions relating to service delivery.

Reporting ‘no recent recruitment’

17.1. There is a specific process for logging the fact that there has not been any recruitment since the last recorded participant. This is outlined in this CPMS How to Guide for studies that upload a spreadsheet to CPMS on a monthly basis. Recruitment data for most CRN Portfolio studies will be collected via the Local Portfolio Management Systems. For those studies the above manual step to report ‘no recent recruitment’ will not be required. Instead, the fact that no recruitment has been uploaded in LPMS will be reported to CPMS.

Studies that do not consent participants

18.1. The NIHR definition of recruitment (see section 1) states that each study participant who has both provided informed consent to join a study and is taking part in the study (i.e. participants who count towards the sample size of the study as set out in the study protocol), should be recorded as a line of recruitment data in CPMS. If no form of consent is taken and the participation does not meet the NIHR definition of recruitment then there is no requirement to upload recruitment data. The CRN team associated with the Primary Specialty supporting the study will inform the study team that no recruitment data should be uploaded when confirming entry of the study into CPMS.

18.2. This policy does not apply to studies covered by sections 21 or 22 below, and should be superseded by guidance in those sections in such situations.

18.3. Once a study has been deemed eligible for inclusion in the NIHR CRN Portfolio, it is entitled to receive NHS Support Costs. Studies should not be disadvantaged or deprioritised at a local level because they do not upload recruitment data, or because they appear more complex than other studies. Prioritisation can only occur in accordance with the Department of Health and Social Care’s Eligibility Criteria (section 5).

Questionnaire based studies (implied consent)

19.1. The return of a questionnaire can be considered 'implied consent' - the act of completing and returning the questionnaire by the participant is sufficient to indicate that they understand the study and are willing to participate.

19.2. Any returned questionnaires can be recorded as recruitment events in the portfolio recruitment data uploads, on the assumption that sufficient information is being provided prior to or with the questionnaire to allow the recipient to make an informed choice to participate. It should be the returned, completed questionnaires that are counted, not the number sent out.

19.3. The recruitment location can be difficult to identify for questionnaires. Efforts should be made to identify the location of questionnaire completion where this is ambiguous or a mixed-model is employed (for example, questionnaires may be completed in a waiting room, or at home and then returned to the study team).

Please follow the below guidance when recording the recruitment location of questionnaires:

• where a questionnaire is completed at a site listed in CPMS (e.g. in a hospital waiting room, as opposed to a non-coded location such as a participant’s home), the site where the questionnaire is completed should be recorded.
• if the questionnaire completion site is not known, but the source of the questionnaire is, then that may be used. For example, some primary care studies might ask GPs to send out the questionnaire to their patients, and have an indicator on the questionnaire of which GP practice the recruit is linked to.
• if neither the completion location nor the distribution location are known, the location/organisation where the completed questionnaires are received and processed is quite often the only practical location to use, particularly for online questionnaires.
• there are also a number of site codes available that can be used to indicate recruitment at an unknown/un-codeable non-NHS location within a specific Local CRN or devolved administration. Please contact the CRN BI team (via the CRN Study Support Helpdesk, (supportmystudy@nihr.ac.uk) for further assistance if you wish to use these codes

19.4. Participants who complete a questionnaire but are known to reside outside of the UK or who were consented outside of the UK should not be included in the recruitment data upload.

Withdrawal of participants

20.1. Participation in a research study is voluntary and a participant is able to withdraw at any time, without giving any reason, and without their medical care or legal rights being affected.

20.2. In cases where recruitment data has previously been uploaded for a participant who later withdraws or is withdrawn/removed from the study, that recruitment data can remain in the system, provided the following criteria were met:

• the participant had met the eligibility criteria for the study, passed screening tests (if applicable) and provided informed consent to take part in a study.
• at the time of consent there was the genuine intention by the investigator to treat/include that participant.

Consent by a legal representative

21.1. Where consent to participate in a research study is provided by a legal representative, personal consultee or nominated consultee on behalf of another person (for example, parental consent on behalf of a child), a line of recruitment data should be uploaded for that participant.

21.2. In this situation, the ‘participant type’ recorded in the recruitment data should relate to the participant taking part in the study (usually a patient with the relevant condition) who is contributing data to answer the research question.

Consent waivers

22.1. In some cases ethical approval to recruit participants without seeking individual informed consent may have been secured. Such studies may be taking place in an emergency setting where the subsequent tracing or follow-up of participants is not feasible/possible, or where the time period for the research activity to be administered is limited, and/or the patients may lack capacity to provide informed consent. (This is not intended to be an exhaustive list.) Where a local ethics committee or the Confidentiality Advisory Group has approved a portfolio study to waive consent when collecting new information/samples for the purposes of research, a line of recruitment data may be uploaded for each participant.

22.2. This policy only applies to portfolio studies, and as such all studies must also meet the definition of research (as outlined in the Department of Health and Social Care Eligibility Criteria).

Note: Research can be defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound 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.

22.3. For recruitment data involving consent waivers, an alternative date will need to be entered in lieu of the date of consent (‘recruitment date’ or ‘activity date’). As one definition is unlikely to fit all scenarios, the following examples may be considered:

• the date on which the individual first presented to the study team/research site (e.g. the date on which they presented at A&E with the relevant condition)
  or
• the date on which the individual was deemed eligible and was included in the study team
  or
• the date on which the study team first received information/sample from that individual

22.4. For recruitment data involving consent waivers, an alternative recruitment site will also need to be entered. The site at which consent would most likely have been taken if the individual had capacity can be used in this instance, or a site that is mapped to the correct parent organisation that is supporting this research activity.

Resources to support the request for recruitment data

23.1. The Clinical Research Network (CRN) was set up to provide infrastructure support to clinical research in the NHS. The support provided by the CRN can include appropriate staff costs, such as Data Managers and Research Management staff and other service support. You should therefore direct queries of this nature to the relevant Local CRN.

Further Guidance

If you have any further queries about recruitment data please contact the NIHR CRN Study Support Service Helpdesk by emailing supportmystudy@nihr.ac.uk

Abbreviations

• CPMS - Central Portfolio Management System
• CRN - Clinical Research Network
• HRA - Health Research Authority
• IRAS - Integrated Research Application System
• LCRN - Local Clinical Research Network
• LPMS - Local Portfolio Management System
• ODS - Organisation Data Service