CCRP PRACTICE SOLUTION 2026 TEST
BANK VIEW AHEAD GRADED A+
⩥ 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
⩥ FDA 50.5 Part D. Answer: obtaining assent form children (cannot be
greater than minimal risk)
⩥ clinical investigation involves what?. Answer: a test article and one or
more human subjects
⩥ emergency use. 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. 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?. Answer: to assure protection
of rights and welfare of human subjects
⩥ "active protocol". Answer: initial review and continuing review every
12 months
BANK VIEW AHEAD GRADED A+
⩥ 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
⩥ FDA 50.5 Part D. Answer: obtaining assent form children (cannot be
greater than minimal risk)
⩥ clinical investigation involves what?. Answer: a test article and one or
more human subjects
⩥ emergency use. 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. 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?. Answer: to assure protection
of rights and welfare of human subjects
⩥ "active protocol". Answer: initial review and continuing review every
12 months
