Slide 1 of 16
Why a SMO is not a CRO, or is it?
Stan W. Woollen
Associate Director for Bioresearch
Monitoring
Office for Good Clinical Practice,
Office of the Commissioner
FDA
Oct. 2001
Slide 2 of 16
A regulator's perspective on CROs/SMOs
-
Today's Clinical Trial Environment
- Environmental pressures driving
evolutionary changes
- Identifying the different
species and their place in
the new environment
-
CRO vs. SMO - A new species
- Similarities and differences
- Regulatory issues
Slide 3 of 16
Today's Clinical Trial Environment
Pressures for change
-
Increased competition for subjects
and investigators
- Large trials widely dispersed
geographically over many sites
- Influx of new Clinical investigators
- Principal investigators remote
to sites
-
Increased need for speed
- Remote data collection and
electronic transmission
- Central IRBs and study monitoring
-
Increased reliance on contractors
(e.g. CROs/SMOs)
- greater fragmentation in
dispersing study functions
Slide 4 of 16
Today's Clinical Trial Environment
Identifying the species
-
Players identified by regulation:
- Investigator/Subinvestigator
- Sponsor
- Sponsor-investigator
- Subject
- Contract Research Organization
(CRO)
- Applicant
- Institutional Review Board
(IRB)
- Institution
Slide 5 of 16
Today's Clinical Trial Environment
Identifying the species
-
Players defined ad hoc
- Site Management Organization
(SMO)
- Monitors/Clinical Research
Associate
- Study Nurse/Coordinator
- Data manager
- Medical monitor
- QA auditor
-
Anyone who participates in
a study activity
Slide 6 of 16
Today's Clinical Trial Environment
Assigning Responsibilities
-
Responsibilities assigned by
regulation
- 21 CFR 312 Subpart D- Responsibilities
of Sponsors and Investigators
- 21 CFR 56 Standards for composition,
operation, and responsibility
of an IRB
- 21 CFR 50 Responsibility
for obtaining informed consent
-
Sponsors, Investigators and
IRBs by regulation
Slide 7 of 16
Today's Clinical Trial Environment
Assigning Responsibility
-
Responsibilities assigned by
contract
- 312.52 Transfer of obligations
to a CRO
- Any or all sponsor obligations
may be transferred
- Transfer must be described
in writing
- If not all obligations
are transferred each obligation
being assumed by the CRO
must be described
- If all are transferred
a general statement is
acceptable
- Any obligation not covered
shall be deemed not to
have been transferred
Slide 8 of 16
Today's Clinical Trial Environment
Assigning Responsibility
-
Responsibilities assigned by
contract
- 312.52 Transfer of obligations
to a CRO, legal liability
- A CRO that assumes any
obligation of a sponsor
shall comply with the specific
regulations applicable
to the obligation
- A CRO is subject to the
same regulatory action
as a sponsor for failure
to comply
- All reference to "sponsor"
in the regs. apply to a
CRO to the extent that
it assumes one or more
obligations of the sponsor
Slide 9 of 16
What is a Contract Research Organization?
-
A CRO means a person that assumes,
as an independent contractor
with the sponsor, one or more
of the obligations of a sponsor,
e.g.., design of a protocol,
selection or monitoring of investigations,
evaluation of reports, and preparation
of materials to b
-
To the extent that an SMO meets
this definition it would be considered
a CR
Slide 10 of 16
Determining Responsibility by Function
-
IF YOU HAVE CONTRACTED WITH
THE SPONSOR TO DO ANY OF THE
FOLLOWINGÖ.
- Select Qualified Investigators.*
- Provide investigators with
information they need to conduct
an investigation properly.
- Ensure proper monitoring
of the investigation(s)
- Ensure study is conducted
in accordance with study plan
and protocol
- Control investigational product(s)
- Safety reporting
-
YOU MAY BE LEGALLY LIABLE AS
A SPONSOR
Slide 11 of 16
What is a Site Management Organization?
(The world according to Stan)
-
A SMO means a person that assumes,
as an independent contractor
with the clinical investigator,
one or more of the regulatory
obligations of a clinical investigator,
e.g., preparation and maintenance
of case histories, ensuring compliance
with IRB review
Slide 12 of 16
Determining Responsibility by Function
-
IF YOU Sign a FDA Form 1572ÖÖ
YOU ARE AN INVESTIGATOR FULLY
COMMITTED TO:
- Personally conduct or supervise
the investigation
- Ensure that all associates,
colleagues, and employees assisting
in study conduct are informed
about their obligations
- Conduct the study in accordance
with the protocol
- Comply with all requirements
regarding obligations of clinical
investigators (including preparation
and maintenance of records)
- Inform subjects drugs are
being used for investigational
purposes and ensure informed
consent and IRB requirements
are met
- Report Adverse Events to
the sponsor
- Read and understand the investigator's
brochure
Slide 13 of 16
CRO vs. SMO Similarities and differences
-
Both are contractors the principal
differences are with whom they
contract, services contracted
for, and their legal liability
- CROs contract with sponsors
and are explicitly regulated
- CROs are legally liable for
the obligations they assume
- SMOs contract with clinical
investigators and are not explicitly
regulated
- SMOs are not legally liable
for the CI obligations they
assume
Slide 14 of 16
Regulatory Issues
-
SMOs assume clinical investigator
duties but the regulations make
no provisions for transfer of
CI responsibilities. CI remains
responsible, though they may
not know it.
-
CROs subcontract sponsor obligations
to SMOs
Slide 15 of 16
Regulatory Issues
-
A CRO's complaint
- Forced to use SMO network
for whom compliance cannot
be assured
- one principal investigator
at SMO HQ with hundreds
of subinvestigators geographically
dispersed
- physical access to site
denied to CROs/Sponsor
monitors
- all monitoring to be
done at central site only
copies available for audit
- IRB selected by SMO remote
to CI, unknown to CRO
Slide 16 of 16
GCP
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