© Christian Sticherling, Michael Kühne 2023
Data Processing and Quality Assurance
The Swiss-AF cohort complies with all legal requirements.
The
local
study
coordinators
and
investigators
work
in
close
collaboration
with
the
Swiss-AF
data
managers
and
provide
information
about
enrolled
patients
and
all
recent
data
by
a
constantly
monitored
web-based
portal
«SecuTrial»
hosted
by
the
Clinical Trial Unit Basel (CTU).
Written
information
about
the
Swiss-AF
cohort
study
and
written
informed
consent
is
obtained
from
all
listed
patients
before
any
study
procedure
is
carried
out.
All
data
are
entered
into
anonymized
patient-specific
online
case
report
forms
(CRFs)
and
are
electronically
transferred
to
a
central
database
system
located
at
the
University
Hospital
Basel
as
the
coordinating
centre.
Standard Operating
Procedures (SOPs)
Standard
operating
procedures
(SOPs)
ensure
the
working
standards,
address
legal
aspects
of
consent
handling,
EKG-
and
MRI-measurement,
bio-sampling
and
updating
of
the
Swiss-AF
cohort infrastructure.
In
accordance
with
the
rules
of
the
Swiss
National
Science
Foundation
(SNSF),
regular
quality
audits
and
written
reports
on
data
entry
and
data
processing
will
be
performed
to
enhance
standardization
of
the
study
procedures
and
to
continuously
check
data
quality
and completeness.
Study Overview
Data Processing and Quality Assurance