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At Mapi
Values
we
believe
in
working
efficiently
to
produce
high
quality
deliverables.
Our
quality
system
supports
these
values,
and has
been
developed
in
accordance
with
principles
that we
feel are
appropriate
to the
field in
which we
work.
Principles
of good
practice
have
been
established
for many
areas
related
to
pharmaceutical
research,
development
and
production.
Those
working
in
preclinical
research
laboratories,
running
clinical
trials,
or
involved
in the
production
of
pharmaceutical
products
are
familiar
with
Good
Laboratory
Practice
(GLP),
Good
Clinical
Practice
(GCP)
and Good
Manufacturing
Practice
(GMP),
respectively.
At Mapi
Values
we have
established
some
guidelines
as the
basis of
Good
Outcomes
Research
Practice.
Our
standards
and
procedures
have
been
developed
with
these
principles
in mind.
For
any
questions
related
to
quality
issues,
please
contact:
Carole
Evans,
PhD:
Operations
Director
- Global
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carole.evans@mapivalues.com
ELEMENTS
OF THE
QUALITY
SYSTEM
Standard
Operating
Procedures
A number
of
Standard
Operating
Procedures
(SOPs)
have
been
issued
and more
are in
development.
Once
issued,
SOPs are
mandatory
and any
deviations
from
SOPs
must be
documented,
with
reasons.
Any
member
of Mapi
Values
staff
can
recommend
development
of a new
SOP or
modification
to an
existing
SOP at
any
time.
SOPs are
also
reviewed
every 3
years.
SOPs
issued
or in
development
include:
- Document and data version control
- Communication
- Data management
- Statistical analysis plans
- Report production
- Training
- Preparation and review of SOPs
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- Filing and archiving
- Project management
- Data tracking and storage (in development)
- Statistical analysis
- Review of deliverables (in development)
- Contracts and budget agreements
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Guidelines
A number
of
guidelines
have
been
issued
and more
are in
development.
Guidelines
are not
mandatory,
but
should
be
followed
whenever
possible
to
ensure
best
practice
and
consistency
across
projects.
Guidelines
issued
or in
development
include:
- Protocol or work plan
- Economic model development
- Obtaining informed consent
- Patient-reported outcomes questionnaire development (in development)
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- Document review
- Economic model validation (in development)
- Systematic reviews (in development)
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Internal
audits
Audits
are
performed
periodically
in each
of the
Mapi
Values
offices
to
assess
compliance
with
current
SOPs and
guidelines.
Following
audits,
feedback
meetings
are held
with the
project
team to
discuss
findings
and
identify
ways to
address
any
issues
raised
by the
audit.
PRINCIPLES
OF GOOD
PRACTICE
Protection
of
patients
and
other
participants
The
participation
of
patients
or other
subjects
such as
caregivers
in
projects
is
always
in
accordance
with the
ethical
principles
that
have
their
origin
in the
Declaration
of
Helsinki:
-
Foreseeable
risks
and
inconveniences
are
weighed
against
the
anticipated
benefit
for
the
individual
participant
and
society;
a
project
is
initiated
and
continued
only
if
the
anticipated
benefits
justify
the
risks.
-
The
rights,
safety,
and
well-being
of
the
participant
are
the
most
important
considerations
and
always
prevail
over
interests
of
science
and
society.
-
Freely
given
informed
consent
is
obtained
from
every
participant
prior
to
project
participation;
consent
can
be
withdrawn
at
any
time.
-
If
participants
are
to
be
observed
or
recorded
during
an
interview,
they
are
informed
of
this
as
part
of
the
process
of
obtaining
consent,
-
The
confidentiality
of
records
that
could
identify
participants
is
protected,
respecting
the
privacy
and
confidentiality
rules
in
accordance
with
the
applicable
regulatory
requirement(s).
-
Where
appropriate,
projects
in
which
participants
are
involved
are
approved
by
an
institutional
review
board
(IRB)/independent
ethics
committee
(IEC).
Scientific
basis
-
Projects
are
based
on
established
scientific
principles,
and
details
are
described
in a
clear,
detailed
protocol
or
similar
document,
which
explicitly
states
the
primary
objectives
of
the
project.
-
Projects
are
conducted,
analysed
and
reported
in
compliance
with
the
protocol
or
similar
document,
or
any
discrepancies
are
documented.
-
Where
relevant,
the
statistical
power
of a
project
is
given
early
consideration
to
ensure
that
the
design
will
allow
the
research
question
to
be
answered.
Personnel
-
Each
individual
involved
in
designing,
conducting,
analysing
and
reporting
a
project
is
qualified
by
education,
training,
and
experience
to
perform
his
or
her
respective
task(s).
Data
handling
-
All
project
information
is
recorded,
handled,
and
stored
in a
way
that
allows
its
accurate
reporting,
interpretation
and
verification;
data
are
stored
in a
way
that
permits
a
complete
retrospective
audit
if
necessary
Publication
-
Published
findings
always
reflect
the
information
gained
from
a
project;
conclusions
that
are
not
adequately
supported
by
the
data
from
a
project
will
never
knowingly
be
disseminated.
-
Authorship
of
publications
should
reflect
contribution
to
the
work;
authors
should
have
participated
sufficiently
in
the
research
to
take
public
responsibility
for
the
content.
Systems
and
procedures
-
Systems
and
procedures
are
implemented
and
regularly
reviewed
to
assure
the
quality
of
every
aspect
of
projects.
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