CCRP SOCRA Objective Assessment Guide Exam Questions and Already graded Solutions and Assured Satisfactions 2024/2025
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CCRP SOCRA
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CCRP SOCRA
CCRP SOCRA Objective Assessment Guide Exam Questions and Already graded Solutions and Assured Satisfactions 2024/2025
An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than _ per year. - correct answer once
Research may receive appr...
CCRP SOCRA Objective Assessment Guide
Exam Questions and Already graded Solutions
and Assured Satisfactions 2024/2025
An IRB shall conduct continuing review of research at intervals
appropriate to the degree of risk, but not less than _ per year. -
correct answer once
Research may receive approval if there is a minority of the IRB
members present at the convened meeting (T/F) - correct
answer false
Every nondiscriminatory effort will be made to ensure that no
IRB consists entirely of one - correct answer gender, profession
If the IRB disapproves a research activity, the IRB can notify the
investigator verbally (T/F) - correct answer false
An IRB member that has a conflicting interest in a project can
participate in the IRB's initial/continuing review (T/F) - correct
answer false
An IRB may use the expedited review procedure to review -
correct answer research involving minimal risk, minor changes
in previously approved research
The IRB is not required to inform all members of proposals that
were approved by expedited review (T/F) - correct answer false
,In order to approve research, the IRB shall determine that the
following requirements are satisfied: - correct answer risks are
minimized/reasonable, selection of subjects is equitable
Documents which individually and collectively permit evaluation
of the conduct of a study and the quality for the data produced. -
correct answer Essential documents
Compilation of the clinical/nonclinical data on the IP that are
relevant to the study of the products in human subjects -
correct answer Investigator's Brochure (IB)
Responsible for providing the up-to-date IB to the responsible
IRBs/IECs - correct answer Investigator
The pretrial monitoring report should be found in the files of the
- correct answer Sponsor
The signed ICFs should be found in the files of the - correct
answer Investigator
The signature sheet documents the signatures/initials of all
persons authorized to make entries/corrections to the CRFs
should be found in the files of the - correct answer Sponsor and
investigator
The subject enrollment log is used to document the chronological
enrollment of subjects by trial number (T/F) - correct answer
True
,If a marketed product is being studied for a new use, an IB
specific to the new use doesn't need to be prepared (T/F) -
correct answer false
The marketing experience section of the IB should include -
correct answer Countries where the IP has been
approved/marketed and where the IP didn't receive
approval/registration for marketing
The final close-out of a trial can only be done when the _ has
reviewed both investigator/sponsor files and confirmed all the
necessary documents are in the appropriate files - correct
answer monitor
A systemic investigation, incl. research dev., testing/eval.,
designed to dev./contribute to generalized knowledge - correct
answer Research
Any public/private entity/agency (incl. federal/state) - correct
answer Institution
The determination of the IRB that the research has been
reviewed, may be conducted at an institution within the
constraints set forth by the IRB/other institutional/federal
requirements - correct answer IRB approval
Research that is conducted/supported by a federal dept./agency,
whether or not it is regulated as defined in 46.102e, must comply
, with all sections of Title 45 CFR Part 46 (T/F) - correct answer
true
If research covered by 45 CFR 46 takes place in foreign
countries, procedures normally followed in foreign countries to
protect human subjects may not differ from those set forth in 45
CFR 46 (T/F) - correct answer false (when research covered by
45 CFR 46 takes place in foreign countries, procedures normally
followed in that country may differ from those set in this policy)
45 CFR 46 does affect state/local laws/regulations, which may
otherwise be applicable and which provide additional protections
(T/F) - correct answer false
private information must be individually identifiable in order to
obtain the information to constitute research involving human
subjects - correct answer true
minimal risk means the probability/magnitude of
harm/discomfort are greater than those ordinarily encountered
in daily life or during performance of routine
physical/psychological exams (T/F) - correct answer true
official notification by the institution to the supporting agency, in
accordance with 45 CFR 46, that a research project involving
human subjects has been reviewed/approved by the IRB -
correct answer certification
federal funds administered by a dept./agency may not be
expended for research involving human subjects unless the
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