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IT Protocol Statements
REDCap Internal to BRU
A database will be maintained containing study specific and clinical information gathered by a
questionnaire for participants in the study. The database will also contain [participant's date of birth,
study specific IDs, NHS Numbers and UHL system numbers - specific to each study] to allow the
participant data to be identified. The database will be located on a UHL server and will only be
accessible within the UHL network using an encrypted connection. Access to the database will be
restricted to Study and LCBRU IT staff using a username and system enforced strong password.
REDCap Partner Sites
A database will be maintained containing study specific and clinical information gathered by a
questionnaire for participants in the study. The database will also contain [participant's date of birth,
study specific IDs, NHS Numbers and UHL system numbers - specific to each study] to allow the
participant data to be identified. The database will be located on a UHL server and will only be
accessible over the secure NHS N3 network at the specific participating site using an encrypted
connection. Access to the database will be restricted to Study and LCBRU IT staff using a username
and system enforced strong password.
REDCap Survey
A database will be maintained containing study specific and clinical information gathered by a
questionnaire for participants in the study. The database will also contain participant entered [name,
address, date of birth, study specific IDs, NHS Numbers and UHL system numbers - specific to each
study - please include as appropriate] to allow the participant data to be identified. The database will
be located on a University of Leicester server and will be over the internet using an encrypted
connection. Access to the database will be restricted to Study and LCBRU IT staff using their
University of Leicester network account, which employs a strong password policy.
MRBS
A database will be maintained containing information about patient appointments. This will contain no
patient identifiable and no clinical data. The database will be located on a UHL server and will be only
accessible within the UHL network. Access to the database will be restricted to Study and LCBRU IT
staff using their UHL network account, which employs a strong password policy.
Study Calendars
A database will be maintained containing information about patient appointments. This will contain
the patient's name. The database will be located on a UHL server and will be only accessible within
the UHL network. Access to the database will be restricted to Study and LCBRU IT staff using their
UHL network account, which employs a strong password policy.
CiviCRM
A database will be maintained to record a participants involvement in a study. This database will
contain a participant's name, date of birth, address and levels of consent, but will not contain any
clinical details [is this true for all studies]. The database will also contain the mapping between the
partcipant's NHS Number, UHL system number and the study-specific pseudo-anonymous ID The
database will be located on UHL servers and will only be accessible within the UHL network. Access
to the data will be restricted to members of the [study name] research team, the LCBRU
administration and IT staff. Authentication for access to the the database is provided by UHL
Windows network authentication, which enforces a strong password policy.
OpenSpecimen
A database will be maintained to manage the blood and urine samples provided by participants in the
study. The database will store the volume, type and location of samples and will no record any
clinical information. Samples will be identified by their study specific pseudo-anonymous ID. The
database will be located on a University of Leicester server and will be accessible via the
internet. Access to the data will be restricted by a username and password to LCBRU lab staff, [lab
staff at other locations - Gav?], LCBRU IT staff and University of Leicester IT staff.
i2b2
A data warehouse will be maintained containing study specific and clinical information for participants
in the study. The database will contain information obtained from study sources, the UHL clinical data
warehouse and primary care data extracted from GP records. The database will also contain
participant's date of birth, study specific IDs, NHS Numbers and UHL system numbers to allow the
participant data to be collected and identified. The database will be located on a UHL server and will
only be accessible within the UHL network. Access to the database will be restricted to LCBRU and
UHL IT staff [this needs clarification] by use of username and password.
Extracts of data from the LCBRU data warehouse will be fully anonymised unless approval has been
received from the principle investigator.