The NIHR Clinical Research Network makes it possible for patients and
health professionals across England to participate in clinical research studies
in both the NHS and in wider health and social care settings. At the heart of the
CRN's activities is the NIHR CRN portfolio of studies - where we collect
essential information about the activity associated with the set up and delivery
of clinical research in England. Research activity data, often referred to as
recruitment data, is amongst the most important data we collect. Why does the
NIHR Clinical Research Network collect research activity data? Research
activity data is used for a wide range of purposes including performance
monitoring of research studies on the NIHR CRN portfolio; monitoring and
improving the work of the Clinical Research Network, thus improving study
support services; demonstrating the success of the CRN by showing the level
and spread of research activity across the nation - including the national
publication of league tables in England, that show which NHS organisations are
research active - ensuring that the Clinical Research Network's resources are
directed effectively for the greatest patient benefit. So what is research
activity and how is the data collected? Research activity is any activity
related to the enrolment of an individual participant into a research
study. Following digital innovation in the way data is collected, for the
majority of studies, research activity data will be collected by research and
support staff across the UK in Local Portfolio Management Systems.
The collected data will then flow directly into the Central Portfolio
Management System, where it will be confirmed by the Chief Investigator or
their representative, or a representative of the commercial sponsor or CRO. A small
subset of studies will continue to upload directly into the Central
Portfolio Management System using a spreadsheet. What research activity data
do we collect at national level in England? We collect data concerning the
type of activity that has taken place, the date it took place, and the site of
concern. We record research activity at site level - for example a hospital or GP
surgery as this provides us with a detailed view of the geographical
coverage of research activity. This is especially relevant given the direction
of travel towards larger NHS trusts and delivery of research in non NHS settings -
and helps the CRN to facilitate the delivery of research to patients with the
greatest health need. The participant statuses we collect using the new
research activity processor are: consented, recruited, and where appropriate failed
screening.Capturing consented and failed screening statuses, alongside recruited
statuses, gives us a more granular understanding of research activity on
each study - as well as the NIHR CRN portfolio as a whole - and therefore
supports proactive performance monitoring. It also ensures better
visibility of the activity involved in studies. Consented activity is captured
when a participant has provided informed consent to join a study. Sometimes a
participant is required to give multiple consents in relation to a study - for
things such as screening tests and optional subsidies. In such cases, the
date on which a participant first provided informed consent to take part
in the main study should be recorded. A participant is then captured as
recruited where they have provided informed consent to join a study and
has taken part in the study having been deemed eligible according to any
screening test applicable. The participant should also count towards
the study sample size. Failed screening activity is captured when a participant
has given consent to non-standard clinical investigations
procedures or tests relating to a study,
but following these procedures was found to be ineligible to take part in the
study. For studies where there is no element of screening, the consent date is
normally the same as the recruited date - as participants will be eligible to take
part in the trial immediately. The study is using the spreadsheet upload method
of capturing research activity directly in CPMS, recruited data is collected for
non-commercial studies and recruited and failed screening data is collected for
commercial studies. Furthermore we also capture information about the different
types of participants that have been recruited into studies in England. While
the majority of studies recruit patients, studies also routinely recruit other
types of participants such as carers, professionals and healthy volunteers. We
appreciate that locally, additional data items may be collected to support study
delivery in Local Portfolio Management Systems. The participant status and the
types described in this video are the minimum required for data analysis at a
national level in England. What does this mean for you? Everyone who is tasked with
capturing research activity data in LPMS, or confirming it in CPMS should have
a clear understanding of what data they should record, where, and when. If you're a
Chief Investigator, or their nominated representative, or the company
representative for commercial studies -we recommend that during site setup, you
discuss the stages of the study protocol where a participant should be considered
as consented recruited or failed screening to ensure all sites collects
their data appropriately. If you have any questions about how research activity
data should be recorded, or what data you should include,
please contact your Local Clinical Research Network (LCRN) or the NIHR
Coordinating Centre if you are a company representative of a commercial study.