SOCRA CCRP Exam 2026 Questions and
Answers
FDA Part 11 - Correct answer-electronic signatures are of the same validity as
handwritten signatures, must provide 2 identifiers and verify identification of
signer
FDA Part 50 - Correct answer-Food and Drugs, and ICF
FDA Part 56 - Correct answer-IRBs
FDA Part 312 - Correct answer-investigational new drug application
FDA Part 812 - Correct answer-investigational drug exemption
FDA Form 482 - Correct answer-Notice of inspection
FDA Form 483 - Correct answer-Letter of investigational observations/citation of
noncompliance that specifies how long you have to respond.
FDA Form 3454 - Correct answer-Certification - Financial Interests and
Arrangements of Clinical Investigators
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,FDA Form 3455 - Correct answer-Disclosure - Financial Interests and
Arrangements of Clinical Investigators
FDA Form 3500 - Correct answer-For Voluntary Reporting of Adverse Events and
Product Problems
FDA Form 3500A - Correct answer-For Use by User-Facilities, Distributors, and
Manufacturers for Mandatory Reporting
investigator vs. sponsor vs. sponsor-investigator - Correct answer-I: conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
minimal risk - Correct answer-probability and magnitude of harm and discomfort
are not greater than those encountered in day-to-day life
Why should an individual be given ample time and sufficient opportunity to
consider whether or not to participate? (2 reasons) - Correct answer-1) minimize
coercion
2) understandable language
What are exceptions to ICF general requirements? (for emergency use with IRB
approval) - Correct answer-1) life-threatening situation necessitating use of test
article
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,2) patient cannot communicate
3) insufficient time to communicate with legal representative
4) no alternative treatment with equal or greater likelihood of saving subject's life
___________ reports emergency use to __________ within ______ days - Correct
answer-investigator to IRB in 5 working days
How soon should documentation be submitted to IRB after emergency use? -
Correct answer-within 5 days
ICF should contain - Correct answer-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
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
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, short form - Correct answer-states elements of ICF were presented orally to
subject/legal rep, requires witness
Who signs short form? - Correct answer-patient and witness; PI and witness also
sign summary
When a short form is required, is the patient given a copy of the short form, the
summary, or both? - Correct answer-both
FDA 50.5 Part D - Correct answer-obtaining assent form children (cannot be
greater than minimal risk)
clinical investigation involves what? - Correct answer-a test article and one or
more human subjects
emergency use - Correct answer-use of test article when the situation is life-
threatening and there is no standard acceptable treatment available, with no time to
obtain IRB approval
IRB - Correct answer-Institutional Review Board; designated to review, approve
the initiation of, and conduct periodic review of biomedical research involving
human subjects
What is the primary purpose of the IRB? - Correct answer-to assure protection of
rights and welfare of human subjects
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Answers
FDA Part 11 - Correct answer-electronic signatures are of the same validity as
handwritten signatures, must provide 2 identifiers and verify identification of
signer
FDA Part 50 - Correct answer-Food and Drugs, and ICF
FDA Part 56 - Correct answer-IRBs
FDA Part 312 - Correct answer-investigational new drug application
FDA Part 812 - Correct answer-investigational drug exemption
FDA Form 482 - Correct answer-Notice of inspection
FDA Form 483 - Correct answer-Letter of investigational observations/citation of
noncompliance that specifies how long you have to respond.
FDA Form 3454 - Correct answer-Certification - Financial Interests and
Arrangements of Clinical Investigators
©COPYRIGHT 2025, ALL RIGHTS RESERVED 1
,FDA Form 3455 - Correct answer-Disclosure - Financial Interests and
Arrangements of Clinical Investigators
FDA Form 3500 - Correct answer-For Voluntary Reporting of Adverse Events and
Product Problems
FDA Form 3500A - Correct answer-For Use by User-Facilities, Distributors, and
Manufacturers for Mandatory Reporting
investigator vs. sponsor vs. sponsor-investigator - Correct answer-I: conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
minimal risk - Correct answer-probability and magnitude of harm and discomfort
are not greater than those encountered in day-to-day life
Why should an individual be given ample time and sufficient opportunity to
consider whether or not to participate? (2 reasons) - Correct answer-1) minimize
coercion
2) understandable language
What are exceptions to ICF general requirements? (for emergency use with IRB
approval) - Correct answer-1) life-threatening situation necessitating use of test
article
©COPYRIGHT 2025, ALL RIGHTS RESERVED 2
,2) patient cannot communicate
3) insufficient time to communicate with legal representative
4) no alternative treatment with equal or greater likelihood of saving subject's life
___________ reports emergency use to __________ within ______ days - Correct
answer-investigator to IRB in 5 working days
How soon should documentation be submitted to IRB after emergency use? -
Correct answer-within 5 days
ICF should contain - Correct answer-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
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
©COPYRIGHT 2025, ALL RIGHTS RESERVED 3
, short form - Correct answer-states elements of ICF were presented orally to
subject/legal rep, requires witness
Who signs short form? - Correct answer-patient and witness; PI and witness also
sign summary
When a short form is required, is the patient given a copy of the short form, the
summary, or both? - Correct answer-both
FDA 50.5 Part D - Correct answer-obtaining assent form children (cannot be
greater than minimal risk)
clinical investigation involves what? - Correct answer-a test article and one or
more human subjects
emergency use - Correct answer-use of test article when the situation is life-
threatening and there is no standard acceptable treatment available, with no time to
obtain IRB approval
IRB - Correct answer-Institutional Review Board; designated to review, approve
the initiation of, and conduct periodic review of biomedical research involving
human subjects
What is the primary purpose of the IRB? - Correct answer-to assure protection of
rights and welfare of human subjects
©COPYRIGHT 2025, ALL RIGHTS RESERVED 4
