SOCRA PRACTICE EXAMINATION 2026
REAL QUESTIONS SOLVED ANSWERS
DETAILED REVIEW GRADED A+
⩥ 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
REAL QUESTIONS SOLVED ANSWERS
DETAILED REVIEW GRADED A+
⩥ 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
