CCRP SOCRA 2025 MOST RECENT
COMPREHENSIVE QUESTIONS AND
ANSWERS |COMPLETE SOLUTIONS |A+
GRADED |100% CORRECT!!
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Students also studied
Flashcard sets Study guides
C425 OA Review Dosage Calculations: Solving for Do... SBIRT
Teacher 54 terms 20 terms Teacher 46 terms
Wanjiku_Judy Preview Preview jasonmitcham8
electronic signatures are of the same validity as handwritten
FDA Part 11 signatures, must provide 2 identifiers and verify identification of
signer
FDA Part 50 Food and Drugs, and ICF
FDA Part 56 IRBs
FDA Part 312 investigational new drug application
FDA Part 812 investigational drug exemption
FDA Form 482 Notice of inspection
Letter of investigational observations/citation of noncompliance
FDA Form 483
that specifies how long you have to respond.
Certification - Financial Interests and Arrangements of Clinical
FDA Form 3454
Investigators
Disclosure - Financial Interests and Arrangements of Clinical
FDA Form 3455
Investigators
For Voluntary Reporting of Adverse Events and Product
FDA Form 3500
Problems
For Use by User-Facilities, Distributors, and Manufacturers for
FDA Form 3500A
Mandatory Reporting
I: conducts trial
investigator vs. sponsor vs.
S: initiates trial (manages and finances)
sponsor-investigator
S-I: conducts and initiates trial
probability and magnitude of harm and discomfort are not
minimal risk
greater than those encountered in day-to-day life
, Why should an individual be 1) minimize coercion
given ample time and sufficient 2) understandable language
opportunity to consider whether
or not to participate? (2
reasons)
1) life-threatening situation necessitating use of test article
What are exceptions to ICF
2) patient cannot communicate
general requirements? (for
3) insufficient time to communicate with legal representative
emergency use with IRB
4) no alternative treatment with equal or greater likelihood of
approval)
saving subject's life
___________ reports emergency use investigator to IRB in 5 working days
to __________ within ______ days
How soon should within 5 days
documentation be submitted to
IRB after emergency use?
1) explanation of purpose, duration of subject participation, etc.
2) any possible risks
3) any possible benefits
4) alternative treatments
5) confidentiality and possibility of FDA inspection
ICF should contain
6) contact info
7) participation is voluntary
8) removal of PHI from biospecimens and if they will include
genome sequencing
9) details of termination/option to withdraw
states elements of ICF were presented orally to subject/legal
short form
rep, requires witness
Who signs short form? patient and witness; PI and witness also sign summary
When a short form is required, is both
the patient given a copy of the
short form, the summary, or
both?
obtaining assent form children (cannot be greater than minimal
FDA 50.5 Part D
risk)
clinical investigation involves a test article and one or more human subjects
what?
use of test article when the situation is life-threatening and there
emergency use is no standard acceptable treatment available, with no time to
obtain IRB approval
Institutional Review Board; designated to review, approve the
IRB initiation of, and conduct periodic review of biomedical research
involving human subjects
What is the primary purpose of to assure protection of rights and welfare of human subjects
the IRB?
"active protocol" initial review and continuing review every 12 months
How often do IRB's have to every 3 years
renew registration?
IRB must send any info changes 90
within ____ days of change
COMPREHENSIVE QUESTIONS AND
ANSWERS |COMPLETE SOLUTIONS |A+
GRADED |100% CORRECT!!
Save
Students also studied
Flashcard sets Study guides
C425 OA Review Dosage Calculations: Solving for Do... SBIRT
Teacher 54 terms 20 terms Teacher 46 terms
Wanjiku_Judy Preview Preview jasonmitcham8
electronic signatures are of the same validity as handwritten
FDA Part 11 signatures, must provide 2 identifiers and verify identification of
signer
FDA Part 50 Food and Drugs, and ICF
FDA Part 56 IRBs
FDA Part 312 investigational new drug application
FDA Part 812 investigational drug exemption
FDA Form 482 Notice of inspection
Letter of investigational observations/citation of noncompliance
FDA Form 483
that specifies how long you have to respond.
Certification - Financial Interests and Arrangements of Clinical
FDA Form 3454
Investigators
Disclosure - Financial Interests and Arrangements of Clinical
FDA Form 3455
Investigators
For Voluntary Reporting of Adverse Events and Product
FDA Form 3500
Problems
For Use by User-Facilities, Distributors, and Manufacturers for
FDA Form 3500A
Mandatory Reporting
I: conducts trial
investigator vs. sponsor vs.
S: initiates trial (manages and finances)
sponsor-investigator
S-I: conducts and initiates trial
probability and magnitude of harm and discomfort are not
minimal risk
greater than those encountered in day-to-day life
, Why should an individual be 1) minimize coercion
given ample time and sufficient 2) understandable language
opportunity to consider whether
or not to participate? (2
reasons)
1) life-threatening situation necessitating use of test article
What are exceptions to ICF
2) patient cannot communicate
general requirements? (for
3) insufficient time to communicate with legal representative
emergency use with IRB
4) no alternative treatment with equal or greater likelihood of
approval)
saving subject's life
___________ reports emergency use investigator to IRB in 5 working days
to __________ within ______ days
How soon should within 5 days
documentation be submitted to
IRB after emergency use?
1) explanation of purpose, duration of subject participation, etc.
2) any possible risks
3) any possible benefits
4) alternative treatments
5) confidentiality and possibility of FDA inspection
ICF should contain
6) contact info
7) participation is voluntary
8) removal of PHI from biospecimens and if they will include
genome sequencing
9) details of termination/option to withdraw
states elements of ICF were presented orally to subject/legal
short form
rep, requires witness
Who signs short form? patient and witness; PI and witness also sign summary
When a short form is required, is both
the patient given a copy of the
short form, the summary, or
both?
obtaining assent form children (cannot be greater than minimal
FDA 50.5 Part D
risk)
clinical investigation involves a test article and one or more human subjects
what?
use of test article when the situation is life-threatening and there
emergency use is no standard acceptable treatment available, with no time to
obtain IRB approval
Institutional Review Board; designated to review, approve the
IRB initiation of, and conduct periodic review of biomedical research
involving human subjects
What is the primary purpose of to assure protection of rights and welfare of human subjects
the IRB?
"active protocol" initial review and continuing review every 12 months
How often do IRB's have to every 3 years
renew registration?
IRB must send any info changes 90
within ____ days of change
