R1. What is recruitment and how are recruitment data recorded on the Portfolio database?
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 the Portfolio Database.
R2. Why do I need to provide recruitment data?
The key purpose of the NIHR Clinical Research Network (CRN) is to ensure the effective provision of clinical research infrastructure / NHS service support so that more NHS clinicians can contribute to clinical research and so that more NHS patients and organisations can benefit from being part of a research study. Recruitment data are a key part of the information used to monitor and improve the work of the CRN. These data will also feed into the process of allocating future funding to the NIHR Comprehensive Local Research Networks (CLRNs) to ensure that infrastructure / NHS service support are directed to where they are required. You can find out more information about CLRNs on our website.
R3. What forms can recruitment information take and how is it recorded?
Recruitment data are data relating to:
- patients recruited to a treatment regime
- staff members who have completed 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.
In each of these situations a line of data should be provided, by the named recruitment contact for the study, for each recruit that has consented to participate during the study.
Where a recruitment event occurs twice in the same study, e.g. a staff member completes two questionnaires or a sample is tested twice, the recruitment is only normally counted once.
R4. The recruitment upload template has columns for the inclusion of the dates of birth/gender/postcode.ethnicity, is this information required?
No. Please do not complete these columns, the Portfolio Database will not accept information that is included in these columns, and will provide you with a warning indicating that these columns should not be completed. The NIHR CRN do not collect data on date of birth/gender/postcode or ethnicity of participants recruited to NIHR CRN portfolio studies.
R5. We have not gained consent from our participants to pass their information onto a third party. Does this mean that we are unable to pass the information onto the NIHR CRN CC?
You are able to pass information to us. Security of information pertaining to participants in the studies registered on the Portfolio is extremely important to us. The fields on the spreadsheet that provide information which could identify the patient directly are not mandatory. We also ask that you ensure your Study Patient Number is not a hospital or NHS number or any other type of data that could identify an individual patient. None of the mandatory data required, therefore, should directly identify the patient. We do not publish the detailed recruitment data you provide us with; only total numbers of study participants are made publicly available.
R6. Should I provide information on study participants from the Devolved Nations or from other countries?
Data for participants recruited in the Devolved Nations (Scotland, Wales and Northern Ireland) should be included. The Portfolio database will allocate data to the appropriate Clinical Research Networks for resource allocation purposes. Recruits from outside the UK should not have a row of data listed, but should be included in the running total. As you may have seen on the Portfolio database, entries for non-commercial studies that are open have a percentage bar to indicate how far forward they are with recruiting their planned sample size. This bar is calculated from the running total column in your spreadsheet. Therefore if you omit patients recruited from outside the UK from your running total it will appear as if you are underachieving against your planned sample size.
R7. Our study is open to recruitment, but we have not recruited anyone. Can we record this?
Yes, there is a specific process for logging the fact that there has not been any recruitment. This is outlined in the Recruitment Upload User Guide.
R8. The research question that my study is addressing is part of a larger programme of research work which is already registered on the Portfolio and is submitting recruitment. Should I submit my study for inclusion on the Portfolio as a study in its own right and then report recruitment separately for this sub-study?
For the purposes of the Portfolio, a study is generally defined as a structured research activity which is the subject of a single ethics approval. Therefore, if the research question being addressed in the sub-study, or “nested study” is covered by the ethics approval which covers the main study, the sub-study would not be viewed as a separate study in its own right and recruitment would not be submitted for this study separately as it will already be being collected for the main study. However, if the sub-study or "nested" study is the subject of a separate ethics approval and patients who have previously consented into the main study were 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 considered for acceptance onto the Portfolio as a separate study and would report recruitment separately.
R9. My study does not involve the recruitment of patients but is addressing a “Service Delivery, Organisation” type of research question which involves the collection and analysis of information relating to organisations, e.g. GP practices/nursing homes/hospital wards, how do I record this?
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.
R10. The patients participating in my study are being recruited at their local GP practice, however the research project which they are involved in is taking place in a hospital. Should I report the recruitment site name as the GP practice or the hospital?
In general, the site where the patient 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. If however, this is not the case, then discretion should be used, and the local CLRN should decide which is the most appropriate site to be linked to the recruitment.
R11. My study team is under resourced and therefore cannot complete this request for recruitment data. Can I obtain resources elsewhere to support this?
The Comprehensive Clinical Research Network (CCRN) was set up to provide infrastructure support to clinical research in the NHS. The support provided by the CCRN 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 your Topic or Comprehensive Local Research Network.
R12. My study involves recruitment from a mixture of NHS and non-NHS sites (e.g. university building), should I provide recruitment data for all participants or just those recruited from an NHS setting or using NHS resources?
The purpose of the NIHR Clinical Research Network is to ensure that all high quality research funded by the NIHR and its Partners that involves NHS patients, their data or tissues / samples or their carers and/or NHS resources (i.e. staff, premises or facilities) has access to NHS infrastructure for research, including NHS Support Costs.
All studies, including those that have a mix of recruitment from NHS and non-NHS settings (in the UK; with or without NHS involvement) should report all UK recruitment as lines of data in the recruitment upload.
The site of recruitment should be reported as the location where consent to enter the study was taken. Recruitment sites are then mapped to NHS Trusts and Networks. Recruitment from a non-NHS site (in the UK; e.g. a University) that hasn't involved NHS staff and / or resources (e.g. care being funded by NHS) will be mapped to 'Private Trust' and then to the relevant (C) LRN.
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.
R13. My study is eligible for CRN support and is on the NIHR CRN Portfolio, however the study does not consent participants and/or the activity does not meet the NIHR CRN definition of recruitment, will I be required to upload recruitment data?
The NIHR CRN definition of recruitment 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 the Portfolio Database". If no form of consent is taken and the participation does not meet the NIHR CRN definition of recruitment then there is no requirement to upload recruitment data onto the Portfolio Database. The Main Network providing support for the study will inform the study team that no recruitment data should be uploaded when confirming entry of the study onto the Portfolio Database. This policy does not apply to studies which include retrospective consent, assumed consent or consent from a legal representative in an emergency, critical care or end of life situation. For advice on recruitment upload for these studies please see the following FAQs:
R14. My study involves consenting patients retrospectively, either by the study participant or a legal representative, or consent is assumed, can I upload recruitment data?
Retrospective consent from a participant: In some cases ethical approval to recruit patients in an emergency setting with decreased consciousness will have been secured upon the understanding that consent will be sought from the participant if/when they regain consciousness. Following the period of incapacity, the patient has the opportunity to consent to participate. A line of recruitment data may be uploaded for each participant.
Retrospective consent from a legal representative: In some cases ethical approval to recruit patients in an emergency setting with decreased consciousness will have been secured upon the understanding that consent will be sought from a legal representative. Where consent is provided by a legal representative for the participant, a line of recruitment data should be uploaded for that participant.
Assumed consent: In some cases ethical approval to recruit patients in an emergency setting with decreased consciousness will have been secured upon the understanding that there is a period of time in which the patients can formally opt out of the study. A line of recruitment data may be uploaded for each participant with assumed consent only once the time allowed for a return of notice to withdraw from the study has passed.
R15. If I have further queries about collating and uploading recruitment who should I contact?
In the first instance, please contact your Network Portfolio Manager. Alternatively, you may contact the Portfolio Helpdesk via firstname.lastname@example.org.