John Naim PhD Director Clinical Trials Research Unit West Virginia University March 20 2015 West Virginia Clinical and Translational Science Institute Outline Historical Perspective Legal Framework ID: 911010
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Slide1
SoCRA
Review: Investigator Roles and Responsibilities in Clinical Research
John Naim, PhDDirectorClinical Trials Research UnitWest Virginia UniversityMarch 20, 2015
Slide2West Virginia Clinical and Translational Science Institute
Outline
Historical Perspective
Legal Framework
Clinical Investigator
Roles and Responsibilities
GCP Q & A
Discussion
Slide3West Virginia Clinical and Translational Science Institute
Disclaimer
Information from: FDA Clinical Investigator Training Course
http://
www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM378565.pdf
GCP
questions from Paul Below presentation:
http://
www.slideshare.net/PaulBelow/so-you-think-you-know-gcp-mar-2013
Slide4West Virginia Clinical and Translational Science Institute
Historical Perspective
Past transgressions lead to the need for laws that protect the rights and welfare of human subjects.
Nuremberg Doctors Trial of 1946 (Nuremberg Code)
Thalidomide Tragedy (Kefauver-Harris Amendment)
Tuskegee Experiments (Belmont Report)
Human Radiation Experiments
Gene Transfer
Experiment
Slide5West Virginia Clinical and Translational Science Institute
Historical Perspective
Past transgressions lead to the need for laws that protect the rights and welfare of human subjects.
Nuremberg Doctors Trial of 1946 (Nuremberg Code)
Thalidomide Tragedy (Kefauver-Harris Amendment)
Tuskegee Experiments (Belmont Report)
Human Radiation Experiments
Gene Transfer
Experiment
The public trust is
sine qua non
of clinical research
Slide6West Virginia Clinical and Translational Science Institute
Federal
Food, Drug, and Cosmetic Act (FD&C Act)
Section
505(
i
) is the statutory authority for
FDA’s oversight
of clinical investigations to test safety
and effectiveness
Code
of Federal Regulations (CFR)
Regulations
promulgated under Section 505(
i
) describing
FDA’s authority over the conduct
of clinical
investigations including
-Sponsor
Responsibilities
-Clinical
Investigator
Responsibilities
Guidance
– advisory only, to assist clinical investigators and sponsors in complying with the
regulations
FDA
Form 1572 – by signing this form, an investigator agrees to conduct a study in accordance with
the protocol
and applicable regulations and to
provide adequate
supervision of a study
Legal Framework
Slide7West Virginia Clinical and Translational Science Institute
Good Clinical Practice (GCP)
: A standard for the
design
, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are
protected.
Legal
Framework (
cont.)
Slide8West Virginia Clinical and Translational Science Institute
The Clinical Investigator
An individual who
actually conducts
a study (i.e. under
whose immediate
direction the drug
is dispensed
to a subject.)
In the event an investigation
is conducted
by a team of
individuals, the
investigator is the
responsible leader
of the team.
[
21 CFR 312.3]
Slide9West Virginia Clinical and Translational Science Institute
Investigator Roles
Good Clinical Practice (GCP) in FDA‐regulated research is not the same as
good clinical
practice in caring for patients
For
example, FDA regulations have
very specific
requirements for following
the protocol
, recordkeeping, and
drug accountability
Regulations
are designed
to:
-Ensure
the quality and integrity of
data collected
in clinical trials
-Ensure
that the rights, safety and
welfare of
research participants
are protected
Slide10West Virginia Clinical and Translational Science Institute
Commitments on Form 1572
Personally
conduct or supervise investigation
Follow protocol
Ensure all persons assisting is study are informed of obligations
Inform subjects that drugs are being used for investigational purposes
Ensure informed consent (21 CFR Part 50) and IRB review
, approval
and reporting (21 CFR Part 56)
Report to sponsor adverse events (21 CFR 312.64)
Maintain adequate and accurate records and make them available for inspection in accordance with 21 CFR 312.68
Ensure initial and continuing review by an IRB and report all changes to research and unanticipated problems involving risks to subjects, not make any changes without IRB
approval except
where necessary to eliminate immediate hazards
Comply with other requirements in 21 CFR 312
Slide11West Virginia Clinical and Translational Science Institute
Frequently Asked Questions Form 1572
Why does this form need to be completed by an investigator?
Slide12West Virginia Clinical and Translational Science Institute
Frequently Asked Questions Form 1572
Why does this form need to be completed by an investigator?
1)
To provide the sponsor with information about the investigator’s qualifications and clinical site. 2) To inform the investigator of his/her obligations and obtain the investigator’s commitment to follow pertinent FDA regulations.
Making willfully false statement is a criminal offense
.
Slide13West Virginia Clinical and Translational Science Institute
Frequently Asked Questions Form 1572
Does the 1572 need to be submitted to FDA?
Slide14West Virginia Clinical and Translational Science Institute
Frequently Asked Questions Form 1572
Does the 1572 need to be submitted to FDA?
No. Although the sponsor is required to collect 1572 from the investigator, FDA does not require the form to be submitted to the agency.
Slide15West Virginia Clinical and Translational Science Institute
Frequently Asked Questions Form 1572
Are CVs required to be signed and dated?
Slide16West Virginia Clinical and Translational Science Institute
Frequently Asked Questions Form 1572
Are CVs required to be signed and dated?
No. FDA regulations do not require a CV to be signed and dated. The investigator’s dated signature on the 1572 is sufficient to attest to the accuracy of the CV or other statement of qualifications submitted.
Slide17West Virginia Clinical and Translational Science Institute
Investigator Responsibilities
General responsibilities (312.60)
Control
of investigational drug (312.61)
Record
keeping and retention (312.62)
Maintaining
adequate records of the disposition of the drug
Accurate
case histories that record all observations, and
Other
data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation
An
investigator is required to maintain
investigation records
for:
2
years following the data a marketing application is approved for the drug for the indication for which it is being
investigated
2 years after the investigation is discontinued and FDA is notified if no application is to be filed or if the application has not approved for such indication
Slide18West Virginia Clinical and Translational Science Institute
Investigator Responsibilities
(cont.)
Investigator reports (312.64)
Progress
reports
Safety
reports
Promptly
report any adverse event that may reasonably
be regarded
as caused by, or probably caused by, the drug (err on the side of reporting
)
Immediately
report any adverse event that is alarming (e.g. an unexpected event that is serious or life‐threatening)
Final
report
Financial
disclosure
Slide19West Virginia Clinical and Translational Science Institute
FDA Guidance
Investigator Responsibilities
Outlines
FDA expectations for study oversight Appropriate
delegation
of study tasks
Appropriate
training
of study staff
Appropriate
supervision
of conduct of ongoing study
Appropriate
oversight of third
parties
involved
in the study (e.g. Site
Management Organizations
, outside labs
specifically retained
to conduct study assessments)
Slide20West Virginia Clinical and Translational Science Institute
FDA Guidance
Investigator Responsibilities (Cont.)
Outlines FDA expectations for
protecting the
rights, safety, and welfare of subjects
Provision
of reasonable medical
care for issues related to study participation (e.g.to manage an adverse event)
Facilitation of care for other health issues
that might arise during the study
Avoiding exposure
of subjects
to
unreasonable
risks
Slide21West Virginia Clinical and Translational Science Institute
Ready for some GCP Questions?
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Slide35West Virginia Clinical and Translational Science Institute
Questions?
Thank You
Made possible by
IDeA
CTR support –
NIH
/NIGMS Award Number
U54GM104942
www.wvctsi.org