CCRP SOCRA 2025 MOST RECENT COMPREHENSIVE
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
FDA Part 11 - CORRECT ANSWERS electronic signatures are of the same
validity as handwritten signatures, must provide 2 identifiers and verify
identification of signer
FDA Part 50 - CORRECT ANSWERS Food and Drugs, and ICF
FDA Part 56 - CORRECT ANSWERS IRBs
FDA Part 312 - CORRECT ANSWERS investigational new drug application
FDA Part 812 - CORRECT ANSWERS investigational drug exemption
FDA Form 482 - CORRECT ANSWERS Notice of inspection
FDA Form 483 - CORRECT ANSWERS Letter of investigational
observations/citation of noncompliance that specifies how long you have to
respond.
FDA Form 3454 - CORRECT ANSWERS Certification - Financial Interests and
Arrangements of Clinical Investigators
,CCRP SOCRA 2025 MOST RECENT COMPREHENSIVE
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
FDA Form 3455 - CORRECT ANSWERS Disclosure - Financial Interests and
Arrangements of Clinical Investigators
FDA Form 3500 - CORRECT ANSWERS For Voluntary Reporting of Adverse
Events and Product Problems
FDA Form 3500A - CORRECT ANSWERS For Use by User-Facilities,
Distributors, and Manufacturers for Mandatory Reporting
investigator vs. sponsor vs. sponsor-investigator - CORRECT ANSWERS I:
conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
minimal risk - CORRECT ANSWERS 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 ANSWERS
1) minimize coercion
2) understandable language
,CCRP SOCRA 2025 MOST RECENT COMPREHENSIVE
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
What are exceptions to ICF general requirements? (for emergency use with IRB
approval) - CORRECT ANSWERS 1) life-threatening situation necessitating
use of test article
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 ANSWERS investigator to IRB in 5 working days
How soon should documentation be submitted to IRB after emergency use? -
CORRECT ANSWERS within 5 days
ICF should contain - CORRECT ANSWERS 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
, CCRP SOCRA 2025 MOST RECENT COMPREHENSIVE
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
8) removal of PHI from biospecimens and if they will include genome sequencing
9) details of termination/option to withdraw
short form - CORRECT ANSWERS states elements of ICF were presented
orally to subject/legal rep, requires witness
Who signs short form? - CORRECT ANSWERS 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 ANSWERS both
FDA 50.5 Part D - CORRECT ANSWERS obtaining assent form children
(cannot be greater than minimal risk)
clinical investigation involves what? - CORRECT ANSWERS a test article and
one or more human subjects
emergency use - CORRECT ANSWERS 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
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
FDA Part 11 - CORRECT ANSWERS electronic signatures are of the same
validity as handwritten signatures, must provide 2 identifiers and verify
identification of signer
FDA Part 50 - CORRECT ANSWERS Food and Drugs, and ICF
FDA Part 56 - CORRECT ANSWERS IRBs
FDA Part 312 - CORRECT ANSWERS investigational new drug application
FDA Part 812 - CORRECT ANSWERS investigational drug exemption
FDA Form 482 - CORRECT ANSWERS Notice of inspection
FDA Form 483 - CORRECT ANSWERS Letter of investigational
observations/citation of noncompliance that specifies how long you have to
respond.
FDA Form 3454 - CORRECT ANSWERS Certification - Financial Interests and
Arrangements of Clinical Investigators
,CCRP SOCRA 2025 MOST RECENT COMPREHENSIVE
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
FDA Form 3455 - CORRECT ANSWERS Disclosure - Financial Interests and
Arrangements of Clinical Investigators
FDA Form 3500 - CORRECT ANSWERS For Voluntary Reporting of Adverse
Events and Product Problems
FDA Form 3500A - CORRECT ANSWERS For Use by User-Facilities,
Distributors, and Manufacturers for Mandatory Reporting
investigator vs. sponsor vs. sponsor-investigator - CORRECT ANSWERS I:
conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
minimal risk - CORRECT ANSWERS 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 ANSWERS
1) minimize coercion
2) understandable language
,CCRP SOCRA 2025 MOST RECENT COMPREHENSIVE
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
What are exceptions to ICF general requirements? (for emergency use with IRB
approval) - CORRECT ANSWERS 1) life-threatening situation necessitating
use of test article
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 ANSWERS investigator to IRB in 5 working days
How soon should documentation be submitted to IRB after emergency use? -
CORRECT ANSWERS within 5 days
ICF should contain - CORRECT ANSWERS 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
, CCRP SOCRA 2025 MOST RECENT COMPREHENSIVE
QUESTIONS AND ANSWERS UPDATED 2024/2025 A
COMPLETE SOLUTIONS ALL ANSWERS CORRECT
DETAILED BEST GRADED TO SCORE A+ FOR
SUCCESS
8) removal of PHI from biospecimens and if they will include genome sequencing
9) details of termination/option to withdraw
short form - CORRECT ANSWERS states elements of ICF were presented
orally to subject/legal rep, requires witness
Who signs short form? - CORRECT ANSWERS 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 ANSWERS both
FDA 50.5 Part D - CORRECT ANSWERS obtaining assent form children
(cannot be greater than minimal risk)
clinical investigation involves what? - CORRECT ANSWERS a test article and
one or more human subjects
emergency use - CORRECT ANSWERS 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
