A set of regulations for the protection of human participants in research, mandated by
Congress in 1974; lead to the Belmont Report
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National Research Act
,guidelines developed by the ICH for global implementation on April 30, 1996;
developed in consideration of the current practices of the EU, Japan, US as well as
Australia, Canada, the Nordic countries, and the WHO
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GCP
inactive substances used as a carrier for the active ingredients of a medication
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Excipients
label device, maintain records and make reports, obtain IRB approval for SR or NSR
designation, obtain informed consent(or waive if minimal risk per IRB), monitor study,
refrain from promotion
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requirements for devices
requirement 5/5 of sponsor initiated IND
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, Protocol(s)
Established in 1976
-Most devices (90%) are marketed as 510(k)s- meaning that the sponsor can provide data
that device is comparable to an already approved device
-Mostly class I and II devices
-FDA applies "clearance" NOT approval
-Might contain clinical data
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510K clearance
studies in multiple species to select doses for repeated dose studies; look for AEs/SAEs
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Single dose toxicity
study design that involves focuses on tolerance and may be placebo controlled
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dose escalation
, must contain pharmacology and toxicology information, previous human experience
with investigational drug, and additional information(i.e. drug dependence and abuse
potential, exposure to radiation, plans for pediatric studies)
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sponsor initiated IND
study participants who require special protections such as prisoners, pregnant women,
children, handicapped, mentally disabled and economically/educationally
disadvantaged
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Vulnerable Subjects
although rare, this can affect public confidence in the clinical trial process; it raises
questions about the effectiveness of trial monitoring and its follow-up by sponsors
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scientific misconduct
Membership is reviewed, meeting minutes reviewed, materials submitted by investigator
looked at, Staff is interviewed, info is obtained about policies and procedures
Congress in 1974; lead to the Belmont Report
Give this one a try later!
National Research Act
,guidelines developed by the ICH for global implementation on April 30, 1996;
developed in consideration of the current practices of the EU, Japan, US as well as
Australia, Canada, the Nordic countries, and the WHO
Give this one a try later!
GCP
inactive substances used as a carrier for the active ingredients of a medication
Give this one a try later!
Excipients
label device, maintain records and make reports, obtain IRB approval for SR or NSR
designation, obtain informed consent(or waive if minimal risk per IRB), monitor study,
refrain from promotion
Give this one a try later!
requirements for devices
requirement 5/5 of sponsor initiated IND
Give this one a try later!
, Protocol(s)
Established in 1976
-Most devices (90%) are marketed as 510(k)s- meaning that the sponsor can provide data
that device is comparable to an already approved device
-Mostly class I and II devices
-FDA applies "clearance" NOT approval
-Might contain clinical data
Give this one a try later!
510K clearance
studies in multiple species to select doses for repeated dose studies; look for AEs/SAEs
Give this one a try later!
Single dose toxicity
study design that involves focuses on tolerance and may be placebo controlled
Give this one a try later!
dose escalation
, must contain pharmacology and toxicology information, previous human experience
with investigational drug, and additional information(i.e. drug dependence and abuse
potential, exposure to radiation, plans for pediatric studies)
Give this one a try later!
sponsor initiated IND
study participants who require special protections such as prisoners, pregnant women,
children, handicapped, mentally disabled and economically/educationally
disadvantaged
Give this one a try later!
Vulnerable Subjects
although rare, this can affect public confidence in the clinical trial process; it raises
questions about the effectiveness of trial monitoring and its follow-up by sponsors
Give this one a try later!
scientific misconduct
Membership is reviewed, meeting minutes reviewed, materials submitted by investigator
looked at, Staff is interviewed, info is obtained about policies and procedures
