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CCRP SOCRA Preparedness baseline Exam knowledge Questions with Expertly written solution 2024/2025
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CCRP SOCRA Preparedness baseline Exam knowledge Questions with Expertly written solution 2024/2025 What FDA regulations govern UADE reporting? - correct answer 21 CFR 812 (.15 and .3) What regulations govern research with pregnant women and fetuses? - correct answer 45 CFR 46 Subpart B Wha...

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Document information

  • November 5, 2024
  • 57
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • uade reporting
  • 45 cfr 46 subpart b
  • irb
  • 21 cfr 54
  • nsr studies
  • clinical trial protocol
  • ccrp socra preparedness baseline exam knowledge qu

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  • CCRP SOCRA

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CCRP SOCRA Preparedness baseline Exam
knowledge Questions with Expertly written
solution 2024/2025

What FDA regulations govern UADE reporting? - correct
answer 21 CFR 812 (.15 and .3)


What regulations govern research with pregnant women and
fetuses? - correct answer 45 CFR 46 Subpart B


What requirements must be met to conduct research with
pregnant women/fetuses? - correct answer 1) With preclinical
and clinical data on non-pregnant women assessing risk to
pregnant women
2) Risk to fetus may result in direct benefit for woman or fetus,
or risk is not greater than minimal + knowledge can't be
obtained any other way
3) Risk is least possible
4) Consent obtained
5) Research benefitting fetus only requires mom+dad consent
6) Individuals providing consent understand impact on neonate
7) Assent + permission for pregnant children required
8) No inducements offered to terminate pregnancy
9) Researchers have no part in decisions to terminate pregnancy
10) Researchers have no part in determining viability of neonate

,When is father's consent not required for research involving
neonates? - correct answer - When there is prospect of benefit
to mom
- When dad unavailable, incompetent or temporarily
incapacitated
- Rape/incest


What regulations provide research protections to children? -
correct answer 45 CFR 46 Subpart D


What is the legal age to provide consent in US? - correct
answer Varies by state, but generally 18


IRBs must classify research involving children into what
categories? (4) - correct answer 1) Minimal risk only
2) Greater than minimal risk but may provide direct benefit
3) Greater than minimal risk with no potential benefit but
generalizeable knowledge could be obtained
4) Presents opportunity to understand, prevent or alleviate a
serious problem affecting health/welfare of kids, but not
otherwise approvable


What 2 criteria must research in kids with > minimal risk and
prospect of benefit meet to be IRB-approved? - correct answer
1) Risk is justified by benefit
2) Relationship of risk to benefit is at least as favorable as any
alternative

,What 3 criteria must research in kids with > minimal risk and no
benefit meet to be IRB-approved? - correct answer 1) Risk is
minor increase over minimal
2) Intervention experience is reasonably comparable to clinical
care
3) Knowledge will be generalizeable


What criterion must otherwise unapprovable research in kids
meet to be IRB-approved? - correct answer Presents
opportunity to further understand, prevent or alleviate a
significant problem affecting health/welfare of children and
conducted with sound ethical principles


Who determines whether consent is needed from child, mom
and/or dad? - correct answer IRB


What 3 criteria should IRB consider when determining assent
requirements? - correct answer 1) Nature of research
2) Child's age, status and condition
3) Whether all or some of children to be included will be capable
of assenting


What should happen when a child research subject turns 18? -
correct answer Re-consent


What 2 additional protections are afforded child wards of the
state? - correct answer 1) Research > minimal risk w/ no
benefit must be directly related to wards or conducted in setting
where majority of kids aren't wards

, 2) Advocate must be appointed by IRB to give consent for study
participation and protect child's interests


What FDA regulations govern financial disclosure? - correct
answer 21 CFR 54


In what ways may sponsors provide investigator financial
disclosures to the FDA? (3) - correct answer 1) FDA Form 3454
- no financial interests
2) FDA Form 3455 - complete disclosure statement
3) FDA Form 3454/option 3 - no financial disclosure obtained
after due diligence


What relationships are considered when reporting a financial
disclosure? - correct answer Investigator, spouse and
dependent children


What 5 scenarios require financial disclosure? - correct answer
1) Compensation to PI affected by study outcome
2) Proprietary interest in tested product
3) Equity interest in sponsor of study whose value can't be
determined during time or study or for 1 yr after
4) Stock in sponsor $50k+ held during study and for 1 yr after
5) Significant payments of $25k+ from sponsor to investigator
during study and for 1 yr after


For what time period must financial interests be disclosed? -
correct answer During course of study + 1 yr after completion

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