SOCRA CCRP ACTUAL EXAM LATEST 2024/2025
QUESTIONS AND VERIFIED CORRECT ANSWERS/ ALREADY
GRADED A++
FDA Part 11 - ANSWER electronic signatures are of the same validity as
handwritten signatures, must provide 2 identifiers and verify identification of
signer
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
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
How often do IRB's have to renew registration? - ANSWER every 3 years
IRB must send any info changes within ____ days of change - ANSWER
90
IRB requirements - ANSWER 1) at least 5 members
2) 1 member whose primary concerns are in the scientific area
3) 1 member whose primary concerns are in a nonscientific area
4) 1 member not affiliated with the institution
5) no IRB members can have conflicts of interest
6) the IRB can invite individuals with expertise in complex areas
Vulnerable people - ANSWER children, prisoners, pregnant women,
physically or mentally disabled people, economically or educationally
disadvantaged people
, True or False: As long as there is a potential for benefit, extremity of risk
does not matter - ANSWER risk must be reasonable in relation to
anticipated benefits
CRF 56.110 Subpart D - ANSWER FDA may restrict, suspend, or
terminated institution's or IRB's use of expedited review to protect rights
and wellbeing of subjects
Examples of research that can utilize expedited review - ANSWER
research involving no more than minimal risk, minor changes in approved
research
Who has the power to disqualify an IRB? - ANSWER the Commissioner,
notice is then sent to FDA
When and why is joint review used? - ANSWER for multi-institutional
studies to avoid duplication of effort
IEC - ANSWER Independent Ethics Committee, includes IRBs
IND should be labeled with ____________ - ANSWER Caution: new drug
with no false or misleading claims
IND Phase 1 - ANSWER initial introduction to determine metabolism,
pharma actions of drug on humans, side effects, to gain early evidence of
effectiveness. for 20-80 patients
IND Phase 2 - ANSWER evaluate effectiveness of drug for particular
indication, determine short term side effects and risks. for 100s of patients
IND Phase 3 - ANSWER expanded controlled and uncontrolled clinical
trials, preliminary effectiveness, additional safety info, evaluation of benefit-
risk relationship, basis for physician labeling. for 100s-1000s of patients
When to protocol, content, investigator, etc. Changes need to be submitted
as amendments? - ANSWER 30-day intervals prior to implementation
IP must provide what in protocol? - ANSWER -drug substance and formula
-effects on animals and humans
-safety and effectiveness
QUESTIONS AND VERIFIED CORRECT ANSWERS/ ALREADY
GRADED A++
FDA Part 11 - ANSWER electronic signatures are of the same validity as
handwritten signatures, must provide 2 identifiers and verify identification of
signer
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
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
How often do IRB's have to renew registration? - ANSWER every 3 years
IRB must send any info changes within ____ days of change - ANSWER
90
IRB requirements - ANSWER 1) at least 5 members
2) 1 member whose primary concerns are in the scientific area
3) 1 member whose primary concerns are in a nonscientific area
4) 1 member not affiliated with the institution
5) no IRB members can have conflicts of interest
6) the IRB can invite individuals with expertise in complex areas
Vulnerable people - ANSWER children, prisoners, pregnant women,
physically or mentally disabled people, economically or educationally
disadvantaged people
, True or False: As long as there is a potential for benefit, extremity of risk
does not matter - ANSWER risk must be reasonable in relation to
anticipated benefits
CRF 56.110 Subpart D - ANSWER FDA may restrict, suspend, or
terminated institution's or IRB's use of expedited review to protect rights
and wellbeing of subjects
Examples of research that can utilize expedited review - ANSWER
research involving no more than minimal risk, minor changes in approved
research
Who has the power to disqualify an IRB? - ANSWER the Commissioner,
notice is then sent to FDA
When and why is joint review used? - ANSWER for multi-institutional
studies to avoid duplication of effort
IEC - ANSWER Independent Ethics Committee, includes IRBs
IND should be labeled with ____________ - ANSWER Caution: new drug
with no false or misleading claims
IND Phase 1 - ANSWER initial introduction to determine metabolism,
pharma actions of drug on humans, side effects, to gain early evidence of
effectiveness. for 20-80 patients
IND Phase 2 - ANSWER evaluate effectiveness of drug for particular
indication, determine short term side effects and risks. for 100s of patients
IND Phase 3 - ANSWER expanded controlled and uncontrolled clinical
trials, preliminary effectiveness, additional safety info, evaluation of benefit-
risk relationship, basis for physician labeling. for 100s-1000s of patients
When to protocol, content, investigator, etc. Changes need to be submitted
as amendments? - ANSWER 30-day intervals prior to implementation
IP must provide what in protocol? - ANSWER -drug substance and formula
-effects on animals and humans
-safety and effectiveness
