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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.
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2. Favorable Risk/Benefit Ratio.
3. Equable Selection Of Subjects.
4. Icf Of Subjects.
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
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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.
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.
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3. Terminate Ongoing Studies When It Would Not Endanger Subjects.
4. Notify State/Federal Agencies When Appropriate. Parent
Institution Is Responsible For Irb
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.
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.
, Page | 2
2. Favorable Risk/Benefit Ratio.
3. Equable Selection Of Subjects.
4. Icf Of Subjects.
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
, Page | 3
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.
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.
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3. Terminate Ongoing Studies When It Would Not Endanger Subjects.
4. Notify State/Federal Agencies When Appropriate. Parent
Institution Is Responsible For Irb
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.
