SOCRA EXAMPREP REVIEW SHEET WITH
TESTED QUESTIONS AND COMPLETE
SOLUTIONS
●● FDA Part 50
Answer: Food and Drugs, and ICF
●● FDA Part 56
Answer: IRBs
●● FDA Part 312
Answer: investigational new drug application
●● FDA Part 812
Answer: investigational drug exemption
●● FDA Form 482
Answer: Notice of inspection
●● FDA Form 483
Answer: Letter of investigational observations/citation of
noncompliance that specifies how long you have to respond.
,●● FDA Form 3454
Answer: Certification - Financial Interests and Arrangements of Clinical
Investigators
●● FDA Form 3455
Answer: Disclosure - Financial Interests and Arrangements of Clinical
Investigators
●● FDA Form 3500
Answer: For Voluntary Reporting of Adverse Events and Product
Problems
●● FDA Form 3500A
Answer: For Use by User-Facilities, Distributors, and Manufacturers for
Mandatory Reporting
●● investigator vs. sponsor vs. sponsor-investigator
Answer: I: conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
●● minimal risk
,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)
Answer: 1) minimize coercion
2) understandable language
●● What are exceptions to ICF general requirements? (for emergency
use with IRB approval)
Answer: 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
Answer: investigator to IRB in 5 working days
●● How soon should documentation be submitted to IRB after
emergency use?
Answer: within 5 days
, ●● ICF should contain
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
●● short form
Answer: states elements of ICF were presented orally to subject/legal
rep, requires witness
●● Who signs short form?
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?
Answer: both
TESTED QUESTIONS AND COMPLETE
SOLUTIONS
●● FDA Part 50
Answer: Food and Drugs, and ICF
●● FDA Part 56
Answer: IRBs
●● FDA Part 312
Answer: investigational new drug application
●● FDA Part 812
Answer: investigational drug exemption
●● FDA Form 482
Answer: Notice of inspection
●● FDA Form 483
Answer: Letter of investigational observations/citation of
noncompliance that specifies how long you have to respond.
,●● FDA Form 3454
Answer: Certification - Financial Interests and Arrangements of Clinical
Investigators
●● FDA Form 3455
Answer: Disclosure - Financial Interests and Arrangements of Clinical
Investigators
●● FDA Form 3500
Answer: For Voluntary Reporting of Adverse Events and Product
Problems
●● FDA Form 3500A
Answer: For Use by User-Facilities, Distributors, and Manufacturers for
Mandatory Reporting
●● investigator vs. sponsor vs. sponsor-investigator
Answer: I: conducts trial
S: initiates trial (manages and finances)
S-I: conducts and initiates trial
●● minimal risk
,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)
Answer: 1) minimize coercion
2) understandable language
●● What are exceptions to ICF general requirements? (for emergency
use with IRB approval)
Answer: 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
Answer: investigator to IRB in 5 working days
●● How soon should documentation be submitted to IRB after
emergency use?
Answer: within 5 days
, ●● ICF should contain
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
●● short form
Answer: states elements of ICF were presented orally to subject/legal
rep, requires witness
●● Who signs short form?
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?
Answer: both
