SOCRA CCRP EXAM QUESTIONS AND
100% VERIFIED ANSWERS
A sponsor should submit a current list of names of investigators to the
FDA every _______ months for significant device investigations.
6 months
Expedited Review
Minimal Risk -or-Minor changes to previously approved research
-Children
-Pregnant Women
-Prisoners
-Handicapped
-Mentally Disabled
-Educationally disadvantaged
-Economically disadvantaged
Vulnerable Populations
Serious, unexpected adverse events that are not fatal or life
threatening must be filed ASAP but no later than ______ after first
knowledge by the sponsor.
15 calendar days
,Selection of Subjects
Principle of Justice
Equitable
IND Inactive Status
IND can be placed inactive if no patients are enrolled for 2 years or all
clinical actions are on hold for 1 year or more
-Investigator notified
-Drugs returned or destroyed
-No annual report required
If an IND is inactive for 5 years or more it may be terminated
If immediate use of test article is required (as determined by PI)
where independent determination cannot be granted, a statement
with exemption from PI and independent clinician must be submitted
to IRB within _______ after use of test article.
5 working days
New, untested or different
Experimental Research
For VOLUNTARY reporting of adverse events
FDA Form 3500
How long is IRB registration with HHS effective for?
45 CFR 46.502
3 years
, FDA will provide written documentation within ______ after FDA
receives IND or IDE application.
30 days
The sponsor must provide notice to FDA within ______ when making a
change to an IDE.
5 working days
IND Safety Reporting - Sponsor must notify FDA & all participating
investigators within ______.
15 days
Sponsor will notify FDA, IRBs and Investigators within ______ after
learning of the recall and device disposition
30 days
45 CFR 46
Protection of Human Subjects
"The Common Rule"
World Medical Association (WMA) ethical principles for medical
research involving human subjects. Originally adopted in June of 1964.
Declaration of Helsinki
An international ethical and scientific quality standard for designing,
conducting, recording and reporting trials that involve participation of
human subjects. Compliance with this standard provides public
assurance that the rights, safety and well being of the trial subjects
are protected.
Good Clinical Practice (GCP)
100% VERIFIED ANSWERS
A sponsor should submit a current list of names of investigators to the
FDA every _______ months for significant device investigations.
6 months
Expedited Review
Minimal Risk -or-Minor changes to previously approved research
-Children
-Pregnant Women
-Prisoners
-Handicapped
-Mentally Disabled
-Educationally disadvantaged
-Economically disadvantaged
Vulnerable Populations
Serious, unexpected adverse events that are not fatal or life
threatening must be filed ASAP but no later than ______ after first
knowledge by the sponsor.
15 calendar days
,Selection of Subjects
Principle of Justice
Equitable
IND Inactive Status
IND can be placed inactive if no patients are enrolled for 2 years or all
clinical actions are on hold for 1 year or more
-Investigator notified
-Drugs returned or destroyed
-No annual report required
If an IND is inactive for 5 years or more it may be terminated
If immediate use of test article is required (as determined by PI)
where independent determination cannot be granted, a statement
with exemption from PI and independent clinician must be submitted
to IRB within _______ after use of test article.
5 working days
New, untested or different
Experimental Research
For VOLUNTARY reporting of adverse events
FDA Form 3500
How long is IRB registration with HHS effective for?
45 CFR 46.502
3 years
, FDA will provide written documentation within ______ after FDA
receives IND or IDE application.
30 days
The sponsor must provide notice to FDA within ______ when making a
change to an IDE.
5 working days
IND Safety Reporting - Sponsor must notify FDA & all participating
investigators within ______.
15 days
Sponsor will notify FDA, IRBs and Investigators within ______ after
learning of the recall and device disposition
30 days
45 CFR 46
Protection of Human Subjects
"The Common Rule"
World Medical Association (WMA) ethical principles for medical
research involving human subjects. Originally adopted in June of 1964.
Declaration of Helsinki
An international ethical and scientific quality standard for designing,
conducting, recording and reporting trials that involve participation of
human subjects. Compliance with this standard provides public
assurance that the rights, safety and well being of the trial subjects
are protected.
Good Clinical Practice (GCP)
