Dublin Academic
Medical Centre
Standard
Operating
Procedure
Dublin
Academic
Medical
Centre
UCD
Clinical
Research
Centre
SOP
Number
1.5
Version
Number
1
SOP
Title
Regulatory
Approval
for
Clinical
Trials
NAME
TITLE
DATE
Author
Jackie
Breiden
Research
Coordinator
30/09/2009
Authoriser
Peter
Doran
Scientific
Director
01/10/2009
Confidential
UCD Clinical Research Centre
Page 1 of 7
Effective
Date:
01/10/2009
Dublin Academic
Medical Centre
Standard
Operating
Procedure
Dublin
Academic
Medical
Centre
UCD
Clinical
Research
Centre
Purpose
This
SOP
describes
the
regulatory
approvals
for
industry
sponsored
clinical
trials
to
be
conducted
at
the
CRC
Specific
procedure
1. Any
sponsor
company
who
wish
to
run
a
clinical
trial
in
Ireland
will
seek
approval
to
run
the
trial
from
the
Irish
Medicines
Board.
2. Any
sponsor
company
who
wish
to
carry
out
a
single
centre
site
clinical
trial
in
the
Clinical
Research
Centre
may
apply
to
any
of
those
ethics
committees
as
recognised
by
the
Department
of
Health
and
Children
under
Regulation
7
of
the
European
Communities
(Clinical
Trials
on
Medicinal
Products
for
Human
Use)
Regulations
2004
(See
www.dohc.ie.)
If
favourable
opinion
for
the
clinical
trial
has
been
given
by
an
ethics
committee
other
than
the
Hospital
Research
Ethics
Committee
the
sponsor
company
must
then
apply
to
the
Hospital
Clinical
Trials
Advisory
Group
for
permission
for
the
clinical
trial
to
be
run
in
the
Clinical
Research
Centre.
3. Any
sponsor
company
who
wish
to
carry
out
a
multicentre
site
clinical
trial
in
Ireland,
may
apply
to
any
of
those
ethics
committees
as
recognised
by
the
Confidential
UCD Clinical Research Centre
Page 2 of 7
Dublin Academic
Medical Centre
Standard
Operating
Procedure
Dublin
Academic
Medical
Centre
UCD
Clinical
Research
Centre
Department
of
Health
and
Children,
under
Regulation
7
of
the
European
Communities
(Clinical
Trials
on
Medicinal
Products
for
Human
Use)
Regulations
2004
(See
www.dohc.ie).
If
favourable
opinion
for
the
multicenter
clinical
trial
has
been
given
by
an
ethics
committee,
other
than
the
Hospital
Research
Ethics
Committee,
the
sponsor
company
must
then
apply
to
the
Mater
Misericordie
University
Hospital
Multicenter
Clinical
Trials
Advisory
Group,
for
permission
for
the
clinical
trial
to
be
run
in
the
Clinical
Research
Centre.
4. If
the
sponsor
company
is
seeking
favourable
opinion
for
a
clinical
trial
from
the
Hospital
Research
Ethics
Committee,
the
Research
Application
Form
will
be
completed
by
the
sponsor
company
and
signed
by
the
principal
investigator.
5. When
completing
the
application,
special
consideration
will
be
given
to
the
Research
Ethics
Committee
guidelines
on
“Notes
to
Researchers
on
Informed
Consent
and
Responsibilities
of
Investigators”
6. 7. Sixteen
hard
copies
of
the
application
form,
study
protocol,
Request
for
Authorisation
of
a
Clinical
Trial
on
a
Medicinal
Product
for
Human
use
to
the
Competent
Authorities
and
for
the
Opinion
of
the
Ethics
Committees
in
the
Community
Form,
patient
information
leaflet,
informed
consent
form
and
other
relevant
study
documents
will
be
submitted
by
the
sponsor
company
to
the
hospital
Ethics
Committee,
by
the
first
Thursday
of
the
month.
Confidential
UCD Clinical Research Centre
Page 3 of 7
Dublin Academic
Medical Centre
Standard
Operating
Procedure
Dublin
Academic
Medical
Centre
UCD
Clinical
Research
Centre
8. Any
queries
regarding
information
required
will
be
resolved
through
direct
communication
between
the
designated
research
study
staff,
sponsor
company,
and
the
Research
Ethics
Committee
Administrator.
9. The
principal
investigator
will
attend
the
Hospital
Research
Ethics
Committee
meeting
when
the
research
study
is
being
reviewed,
as
indicated
by
the
Ethics
Committee
Administrator.
10. Written
approval
will
be
received
from
the
Hospital
Research
Ethics
Committee
or
the
Hospital
Clinical
Trials
Advisory
Group
prior
to
any
clinical
trial
commencement
in
the
Clinical
Research
Centre.
11. The
principal
investigator
will
seek
re
approval
of
the
study
two
years
following
original
approval
and
every
12
months
thereafter.
12. Annual
research
study
update
will
be
the
responsibility
of
the
study
co‐ordinator
and
will
be
forwarded
to
the
Hospital
Research
Ethics
Committee,
upon
review
by
the
principal
investigator
using
the
Research
Update
Form
provided.
Confidential
UCD Clinical Research Centre
Page 4 of 7
Dublin Academic
Medical Centre
Standard
Operating
Procedure
Dublin
Academic
Medical
Centre
UCD
Clinical
Research
Centre
13. Amendments
to
the
protocol
will
be
submitted
to
the
Ethics
Committee
who
gave
favourable
opinion
to
the
clinical
trial,
by
the
sponsor
company.
If
favourable
opinion
for
the
clinical
trial
has
been
given
by
an
ethics
committee
other
than
the
Hospital
Research
Ethics
Committee
the
written
letter
of
approval
for
all
amendments
to
the
protocol
must
be
forwarded
to
the
Mater
Hospital
Clinical
Trials
Advisory
Group
for
their
information
only
prior
to
being
implemented
in
the
Clinical
Research
Centre.
13. All
serious
adverse
events
identified
in
any
of
the
participating
clinical
trial
sites,
which
may
or
may
not
be
related
to
the
study
drug/treatment,
will
be
brought
to
the
attention
of
the
Hospital
Research
Ethics
Committee.
14. An
explanatory
letter
from
the
principal
investigator
involved
in
the
clinical
trial
will
accompany
these
serious
adverse
events
reported
to
the
Hospital
Research
Ethics
Committee.
15. If
the
principal
investigator
wishes
to
continue
with
the
clinical
trial
the
letter
accompanying
the
serious
adverse
event
will
contain
the
following
paragraph
“Having
considered
the
adverse
events
referred
to
herein
I
am
satisfied
that
the
justification
for
conducting
this
trial
has
not
altered
and
that
the
potential
benefits
continue
to
outweigh
any
foreseeable
risk
to
patients
associated
with
this
trial”
Confidential
UCD Clinical Research Centre
Page 5 of 7
Dublin Academic
Medical Centre
Standard
Operating
Procedure
Dublin
Academic
Medical
Centre
UCD
Clinical
Research
Centre
16. On
completion
of
a
research
study
a
Study
Termination
Report
Form
will
be
completed
and
signed
by
the
principal
investigator
and
submitted
to
the
Hospital
Research
Ethics
Committee
Change
History
SOP
no.
Effective
Date
Significant
Changes
Previous
SOP
no.
Confidential
UCD Clinical Research Centre
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Dublin Academic
Medical Centre
Standard
Operating
Procedure
Dublin
Academic
Medical
Centre
UCD
Clinical
Research
Centre
Confidential
UCD Clinical Research Centre
Page 7 of 7