SOCRA CCRP ACTUAL EXAM TERMINAL
CERTIFICATION EVALUATION COMPLETE
QUESTIONS WITH FULL SOLUTION
ALREADY PASSED
⩥ unanticipated AE must be reported by ___________to
_______________in ________ business days.
Answer: investigator to sponsor in 10 days
and then sponsor to FDA within 10 working days
⩥ List 4 situations that must be reported by investigator to sponsor
within 5 working days..
Answer: 1) withdrawal of IRB approval
2) deviations
3) not obtaining ICF
4) significant risk device determinations
⩥ When obtaining informed consent, the PI should adhere to
_____________ and the ethical principles that have their origin in
________________..
Answer: GCP and Declaration of Helsinki
,⩥ Sponsor responsibilities if IRB approval is withdrawn.
Answer: sponsor shall notify FDA, IRBs, and investigator within 5
working days
⩥ The investigator should give the final report to ________________
within ______________________ following study completion..
Answer: to sponsor within 3 months
⩥ Sponsor responsibilities if FDA approval is withdrawn.
Answer: sponsor shall notify IRBs and investigator within 5 working
days
⩥ If a device is recalled, ___________ should notify ____________
withing _________ days.
Answer: sponsor should notify FDA within 30 days
⩥ If the sponsor determined that an unanticipated adverse device effect
present unreasonable risk to patients, what should occur?.
Answer: termination no later than 5 working days after sponsor's
determination, and no later than 15 working days after sponsor first
received notice of effect
⩥ FDA 45 Code of Federal Regulations Part 46.
Answer: public welfare/protection of human subjects
, (with general ICF requirements)
⩥ What is research?.
Answer: systematic intervention designed to develop or contribute to
generalizable knowledge
⩥ What is NOT research?.
Answer: -scholarly or journalistic activities including collecting and
using info
-public health surveillance activities
-collection and analysis of info, biospecimen, or records by a criminal
justice agency authorized by law
-authorized national security activities
⩥ cooperative research.
Answer: projects involving one or more institution, each is responsible
for safeguarding the rights and welfare of human subjects but must rely
on approval of only ONE IRB
⩥ Cooperative research projects with multiple institutions should enter
into what?.
Answer: joint review agreement and rely on IRB of another institution
⩥ According to _________ how long should IRB records be retained?.
CERTIFICATION EVALUATION COMPLETE
QUESTIONS WITH FULL SOLUTION
ALREADY PASSED
⩥ unanticipated AE must be reported by ___________to
_______________in ________ business days.
Answer: investigator to sponsor in 10 days
and then sponsor to FDA within 10 working days
⩥ List 4 situations that must be reported by investigator to sponsor
within 5 working days..
Answer: 1) withdrawal of IRB approval
2) deviations
3) not obtaining ICF
4) significant risk device determinations
⩥ When obtaining informed consent, the PI should adhere to
_____________ and the ethical principles that have their origin in
________________..
Answer: GCP and Declaration of Helsinki
,⩥ Sponsor responsibilities if IRB approval is withdrawn.
Answer: sponsor shall notify FDA, IRBs, and investigator within 5
working days
⩥ The investigator should give the final report to ________________
within ______________________ following study completion..
Answer: to sponsor within 3 months
⩥ Sponsor responsibilities if FDA approval is withdrawn.
Answer: sponsor shall notify IRBs and investigator within 5 working
days
⩥ If a device is recalled, ___________ should notify ____________
withing _________ days.
Answer: sponsor should notify FDA within 30 days
⩥ If the sponsor determined that an unanticipated adverse device effect
present unreasonable risk to patients, what should occur?.
Answer: termination no later than 5 working days after sponsor's
determination, and no later than 15 working days after sponsor first
received notice of effect
⩥ FDA 45 Code of Federal Regulations Part 46.
Answer: public welfare/protection of human subjects
, (with general ICF requirements)
⩥ What is research?.
Answer: systematic intervention designed to develop or contribute to
generalizable knowledge
⩥ What is NOT research?.
Answer: -scholarly or journalistic activities including collecting and
using info
-public health surveillance activities
-collection and analysis of info, biospecimen, or records by a criminal
justice agency authorized by law
-authorized national security activities
⩥ cooperative research.
Answer: projects involving one or more institution, each is responsible
for safeguarding the rights and welfare of human subjects but must rely
on approval of only ONE IRB
⩥ Cooperative research projects with multiple institutions should enter
into what?.
Answer: joint review agreement and rely on IRB of another institution
⩥ According to _________ how long should IRB records be retained?.
