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Developed by:
U-MIC
1
CLINICALTRIALS.GOV
requirements for registration
and informed consent
Developed by:
U-MIC
University of Michigan IRB Collaborative
http://www.ClinicalTrials.gov
ClinicalTrials.gov
Rationale
• Transparency – public knows how its money is
being spent
• Identify clinical trials for participants
• Provide a place where researchers can see what
is going on elsewhere – even before results exist,
to avoid duplication of effort
ClinicalTrials.gov
Why should I
register my study
on
ClinicalTrials.gov?
It’s the law since September 2007!
Food and Drug Administration Amendment Act (FDAAA)
All “Applicable Clinical Trials” must register in ClinicalTrials.gov.
“Applicable Clinical Trials” of FDA approved items must register AND report
results.
ClinicalTrials.gov
Required informed consent language
“A description of this clinical trial will be available on
www.ClinicalTrials.gov, as required by US law. This
website will not include information that can identify
you. At most, the website will include a summary of the
results. You can search this website at any time.”
• This requirement is a federal regulation, and for that reason,
the required language cannot be altered in any way.
ClinicalTrials.gov
“Applicable Clinical Trials”
• If drugs or biologics are involved,
• controlled
• clinical investigations
• subject to FDA regulation
• except Phase I trials
ClinicalTrials.gov
“Applicable Clinical Trials”
• If a device is involved,
• prospective studies of health outcomes
• use an FDA regulated device
• compare an intervention with the device against a control
• except feasibility studies
ClinicalTrials.gov
Exceptions:
•
•
•
•
•
expanded access
continued access
purely retrospective studies
purely observational studies
some bioequivalence studies more like Phase I than II
(most bioequivalence studies are considered
applicable clinical trials)
ClinicalTrials.gov
“As required by law”
Guidance for Sponsors, Investigators, and Institutional Review Boards
Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)
(Small Entity Compliance Guide) Feb. 2012
18. If a clinical trial is not subject to the rule, do investigators have to inform trial participants
about the availability of clinical trial information on www.ClinicalTrials.gov?
No, if the clinical trial is not subject to the rule (not an applicable clinical trial), then
investigators/sponsors do not need to inform participants about the availability of information on
the www.ClinicalTrials.gov website. The required statement should not be included in informed
consent documents or processes for clinical trials that are not applicable clinical trials. However, if
investigators/sponsors independently believe that reporting data on www.ClinicalTrials.gov may
influence subjects’ willingness to participate, nothing in this regulation prevents
investigators/sponsors from voluntarily reporting trial data and informing trial participants in an
appropriate manner.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf
ClinicalTrials.gov
Why else might I
want to register my
study on
ClinicalTrials.gov?
I want study
participants to join
my trial!
I want to publish!
ICMJE says, “Register
or don’t publish in our
journals!”
Reasons to Register
& Use Informed
Consent Language
ClinicalTrials.gov
FDAAA Results & AE
Reporting
FDAAA Registration
ICMJE Registration
Looking for Participants
Additional Resources
• General ClinicalTrials.gov information: http://prsinfo.clinicaltrials.gov, especially
• Elaboration of Definitions of Responsible Party and Applicable Clinical Trial
http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf
• FDAAA related information: http://prsinfo.clinicaltrials.gov/fdaaa.html
• For specific questions or comments: register@clinicaltrials.gov.
• Office of Extramural Research (OER): http://grants.nih.gov/Clinicaltrials_fdaaa/
• Frequently Asked Questions for NIH Grantees:
http://grants.nih.gov/Clinicaltrials_fdaaa/faq.htm
• Instructions for Authors sections of ICJME journals all have information regarding
clinical trial registration
• Office of Regulatory Affairs: http://msa.med.umich.edu/RegulatoryAffairs
Diane Lehman Wilson 764-0634; dlehman@med.umich.edu
THANK YOU.
Diane Lehman Wilson, MPP, JD
Office of Regulatory Affairs
University of Michigan Medical School Administration
Developed by:
U-MIC
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