Welcome to the SYCAMORE Website
The SYCAMORE trial has now stopped recruiting new participants. The Independent Data Safety and Monitoring Committee (IDSMC) have reviewed the data collected so far and have stated that we have enough information from the 90 participants who have taken part so far to suggest that Adalimumab helps to treat patients with Juvenile Idiopathic Arthritis and Uveitis. The independent experts have kept the results confidential until SYCAMORE is finished and all of the data can be looked at. All participants that are currently receiving Adalimumab in the trial will continue to receive trial treatment until they have completed the 18 months treatment phase.
Participants who are taking part in the trial or have taken part can find out more information by looking at the frequently asked questions page here or by speaking to your Doctor.
Information for Participants
University Hospitals Bristol NHS Foundation Trust is the sponsor
for this study based in the United Kingdom; they
have delegated the day-to-day management of the
study to the Clinical Trials Research Centre
(CTRC), which is part of the University of
Liverpool. We will be using information from you
and your medical records in order to undertake
this study and University Hospitals Bristol NHS
Foundation Trust, University of Liverpool and
Bangor University will act as the data
controllers for this study. This means that
University Hospitals Bristol NHS Foundation
Trust, University of Liverpool and Bangor
University are responsible for looking after
your information and using it properly.
University Hospitals Bristol NHS Foundation
Trust, University of Liverpool and Bangor
University will keep identifiable information
about you for 15 years after the study has
finished.
Your rights to access, change or move your information are limited,
as we need to manage your information in
specific ways in order for the research to be
reliable and accurate. To safeguard your rights,
we will use the minimum personally-identifiable
information possible.
You can find out more about how we use your information in the “How
we use your information” section at the end
of this page.
Your NHS hospital will collect information from you and/or your
medical records for this research study in
accordance with our instructions.
Your NHS hospital will use your name,
NHS number and contact details to contact you
about the research study, and make sure that
relevant information about the study is recorded
for your care, and to oversee the quality of the
study. Individuals from
University Hospitals Bristol NHS Foundation Trust,
the
University of Liverpool, Bangor University and
regulatory organisations may look at your
medical and research records to check the
accuracy of the research study. Your NHS
hospital will pass these details to the
University of Liverpool, Bangor University and
University Hospitals Bristol NHS
Foundation Trust
along with the information collected from you
and your medical records. The only people in
University Hospitals Bristol NHS
Foundation Trust, Bangor University
or the University of Liverpool who will have
access to information that identifies you will
be people who need to confirm your participation
in the study or audit the data collection
process. The people who analyse the information
will not attempt to identify you or find out
your name, or contact details.
Your NHS hospital will keep identifiable
information about you from this study for 15
years after the study has finished.
University Hospitals Bristol NHS Foundation,
the
University of Liverpool and Bangor University
will collect information about you for this
research study from Patient-level costing
(PLICS) data from electronic routine NHS health
care records. This information will include data
on any NHS hospital admissions and health
information, which is regarded as a special
category of information. We will use this
information to analyse the cost-effectiveness of
this research study.
When you agree to take part in a research study, the information
about your health and care may be provided to
researchers running other research studies in
this organisation and in other organisations.
These organisations may be universities, NHS
organisations or companies involved in health
and care research in this country or abroad.
Your information will only be used by
organisations and researchers to conduct
research in accordance with the UK Policy Framework for Health and Social Care Research.
This information will not identify you
and will not be combined with other information
in a way that could identify you. The
information will only be used for the purpose of
health and care research, and cannot be used to
contact you or to affect your care. It will not
be used to make decisions about future services
available to you, such as insurance.
How we use
your information
The University Hospitals Bristol NHS Foundation Trust, University of Liverpool and Bangor University
take great care to abide by our legal and moral obligations when handling your personal and healthcare data. Due to changes introduced in the EU General Data Protection Regulation (GDPR), we would like to provide you with information on the lawful basis on which we are processing your data. The lawful basis for the processing of your personal data for the research study which you have participated in is a “task in the public interest”.
As a NHS organisation/University, the University Hospitals Bristol
NHS Foundation Trust, University of Liverpool
and Bangor University uses
personally-identifiable information to conduct
research to improve health, care and services.
As a publicly-funded organisations, we have to
ensure that it is in the public interest when we
use personally-identifiable information from
people who have agreed to take part in research.
This means that when you agree to take part in a
research study, we will use your data in the
ways needed to conduct and analyse the research
study. Your rights to access, change or move
your information are limited, as we need to
manage your information in specific ways in
order for the research to be reliable and
accurate. If you withdraw from the study, we
will keep the information about you that we have
already obtained. To safeguard your rights, we
will use the minimum personally-identifiable
information possible.
Health and care research, which means that we have to demonstrate
that our research serves the interests of
society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
If you wish to raise a complaint on how we have handled your
personal data, you can contact our Data
Protection Officers who will investigate the
matter. If you are not satisfied with our
response or believe we are processing your
personal data in a way that is not lawful you
can complain to the Information Commissioner’s
Office (ICO).
Our Data Protection Officers can be contacted at
InformationGovernance@UHBristol.nhs.uk
Victoria Heath:
LegalServices@liverpool.ac.uk
Gwenan Hine:
gwenan.hine@bangor.ac.uk
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