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SOCRA CERTIFICATION 2025 ACTUAL EXAM
QUESTIONS WITH 100% CORRECT SOLUTIONS
| GUARANTEED SUCCESS.
Use of placebo - correct answer - The benefits, risks, effectivess, etc. must
be tested except: When no proven intervetion exists. Then the use of
placebo, or no intervetion is acceptable. Also, if a compelling and scientific
methodological reasons for intervention
Public Discolsure with INDs - correct answer - 1. IND will not be disclosed
unless previously done.
2. FDA will disclose upon request to an individual given an IND has been
given copy of report on how it relates to use.
Reporting Time Frames - correct answer - 1. Fatal or Life threatening
unexpected ADRs - Qualify for rapid reporting - ASAP - no later than 7
days - follow up report no later than 8 additional days.
2. All other serious, unexpected ADRs must be filed asap - but no later than
15 calendar days.
IRB will determine if study is morally justified and demonstrates what 4 key
items? - correct answer - 1. Adequate Design.
2. Favorable Risk/Benefit ratio.
3. Equable selection of subjects.
4. ICF of subjects.
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Adverse Event (Definition) - correct answer - Any untoward medical
occurrence associated with the use of a drug in humans whether or not
considered drug related. It can therefore be any unfavorable and
unintended sign, symptom, or diagnosis associated with the use of a
medicinal investigational product whether or not related.
Explain the rules relating to financial disclosure? - correct answer -
Responsible for inmplementing the public and confidential financial
disclusre systems to prevent conflicts of interest and to identify potential
conflicts by providing review of the financial interest in both current and
prospective employees.
What is minimal risk. - correct answer - The probability and magnitude of
harm or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life.
Assent for Children - correct answer - 1. Permission of each child's parents
must be granted. Might be one or both. Must be documented.
2. Assent should be obtained unless. Capacity of child is limited so they
can't understand. Intervention of trial is beneficial and only available
through trial.
3. Or if IRB feels: No more than minimal risk. Waiver will not affect subject
rights. Research couldn't happen without assent. Additional info provided
as needed.
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What cirical question must be answered by the IRB? - correct answer -
Does the sum of benefits and importance of knowledge gained from
research outweigh risks to partipants?
When is it ok to test a new intervention against a Placebo and not against
best proven intervention? (Declaration of Helsinki) - correct answer - 1.
When no proven intervention exists.
2. Sound methodical reasons requires it to determine efficacy or safety of
an intervention.
3. Subjects that receive placebo will not be subject to additional risks due to
not receiving best option
How long are IRB registrations effective? - correct answer - 3 years
Administrative Actions for Non-Compliance for IRBs - correct answer - If
FDA observes non-compliance during inspection: May
1. withhold approval of new studies.
2. No new subjects be added to ongoing studies.
3. Terminate ongoing studies when it would not endanger subjects.
4. Notify state/federal agencies when appropriate. Parent institution is
responsible for IRB
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The IRB will determine if a study is morally justified and demonstrates what
key 4 items? - correct answer - 1. Adequate design
2. a favorable risk/benefit ratio
3. equitable selection of subjects
4. informed consent by subjects
What all does the 1572 contain? - correct answer - 1. Name/Address of
investigator
2. Name and protocol #
3. Name and address of every facility where clinical investigations will take
place
4. Name/Address of any clinical lab
5. Name/Address of IRB
6. A commitment by the investigator
Common Deficienceis of FDA inspections - correct answer - Failure to
follow protocol, Deviations, Inadequate record keeping, Inadequate
accountability, ICF issues/subject protections
OHRP - correct answer - Office For Human Research Protections.
1. Protects volunteers in research conducted supported by US Dept. of
Health and Human Services
2. Usually inspects IRBs
SOCRA CERTIFICATION 2025 ACTUAL EXAM
QUESTIONS WITH 100% CORRECT SOLUTIONS
| GUARANTEED SUCCESS.
Use of placebo - correct answer - The benefits, risks, effectivess, etc. must
be tested except: When no proven intervetion exists. Then the use of
placebo, or no intervetion is acceptable. Also, if a compelling and scientific
methodological reasons for intervention
Public Discolsure with INDs - correct answer - 1. IND will not be disclosed
unless previously done.
2. FDA will disclose upon request to an individual given an IND has been
given copy of report on how it relates to use.
Reporting Time Frames - correct answer - 1. Fatal or Life threatening
unexpected ADRs - Qualify for rapid reporting - ASAP - no later than 7
days - follow up report no later than 8 additional days.
2. All other serious, unexpected ADRs must be filed asap - but no later than
15 calendar days.
IRB will determine if study is morally justified and demonstrates what 4 key
items? - correct answer - 1. Adequate Design.
2. Favorable Risk/Benefit ratio.
3. Equable selection of subjects.
4. ICF of subjects.
, Page |2
Adverse Event (Definition) - correct answer - Any untoward medical
occurrence associated with the use of a drug in humans whether or not
considered drug related. It can therefore be any unfavorable and
unintended sign, symptom, or diagnosis associated with the use of a
medicinal investigational product whether or not related.
Explain the rules relating to financial disclosure? - correct answer -
Responsible for inmplementing the public and confidential financial
disclusre systems to prevent conflicts of interest and to identify potential
conflicts by providing review of the financial interest in both current and
prospective employees.
What is minimal risk. - correct answer - The probability and magnitude of
harm or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life.
Assent for Children - correct answer - 1. Permission of each child's parents
must be granted. Might be one or both. Must be documented.
2. Assent should be obtained unless. Capacity of child is limited so they
can't understand. Intervention of trial is beneficial and only available
through trial.
3. Or if IRB feels: No more than minimal risk. Waiver will not affect subject
rights. Research couldn't happen without assent. Additional info provided
as needed.
, Page |3
What cirical question must be answered by the IRB? - correct answer -
Does the sum of benefits and importance of knowledge gained from
research outweigh risks to partipants?
When is it ok to test a new intervention against a Placebo and not against
best proven intervention? (Declaration of Helsinki) - correct answer - 1.
When no proven intervention exists.
2. Sound methodical reasons requires it to determine efficacy or safety of
an intervention.
3. Subjects that receive placebo will not be subject to additional risks due to
not receiving best option
How long are IRB registrations effective? - correct answer - 3 years
Administrative Actions for Non-Compliance for IRBs - correct answer - If
FDA observes non-compliance during inspection: May
1. withhold approval of new studies.
2. No new subjects be added to ongoing studies.
3. Terminate ongoing studies when it would not endanger subjects.
4. Notify state/federal agencies when appropriate. Parent institution is
responsible for IRB
, Page |4
The IRB will determine if a study is morally justified and demonstrates what
key 4 items? - correct answer - 1. Adequate design
2. a favorable risk/benefit ratio
3. equitable selection of subjects
4. informed consent by subjects
What all does the 1572 contain? - correct answer - 1. Name/Address of
investigator
2. Name and protocol #
3. Name and address of every facility where clinical investigations will take
place
4. Name/Address of any clinical lab
5. Name/Address of IRB
6. A commitment by the investigator
Common Deficienceis of FDA inspections - correct answer - Failure to
follow protocol, Deviations, Inadequate record keeping, Inadequate
accountability, ICF issues/subject protections
OHRP - correct answer - Office For Human Research Protections.
1. Protects volunteers in research conducted supported by US Dept. of
Health and Human Services
2. Usually inspects IRBs
