SOCRA CCRP Exam 2026 Questions and
Answers
ICF should contain - Correct 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 - Correct answer-states elements of ICF were presented orally to
subject/legal rep, requires witness
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,Who signs short form? - Correct 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? - Correct answer-both
FDA 50.5 Part D - Correct answer-obtaining assent form children (cannot be
greater than minimal risk)
clinical investigation involves what? - Correct answer-a test article and one or
more human subjects
emergency use - Correct 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
True or False: As long as there is a potential for benefit, extremity of risk does not
matter - Correct answer-risk must be reasonable in relation to anticipated benefits
Examples of research that can utilize expedited review - Correct answer-research
involving no more than minimal risk, minor changes in approved research
Who has the power to disqualify an IRB? - Correct answer-the Commissioner,
notice is then sent to FDA
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, When and why is joint review used? - Correct answer-for multi-institutional
studies to avoid duplication of effort
IEC - Correct answer-Independent Ethics Committee, includes IRBs
IND Phase 1 - Correct 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 3 - Correct 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? - Correct answer-30-day intervals prior to implementation
IP must provide what in protocol? - Correct answer--drug substance and formula
-effects on animals and humans
-safety and effectiveness
-possible risks and side effects
-pharma and toxicology reports (any in vitro and effects on fetus)
-radioactivity and absorption of dose
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Answers
ICF should contain - Correct 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 - Correct answer-states elements of ICF were presented orally to
subject/legal rep, requires witness
©COPYRIGHT 2025, ALL RIGHTS RESERVED 1
,Who signs short form? - Correct 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? - Correct answer-both
FDA 50.5 Part D - Correct answer-obtaining assent form children (cannot be
greater than minimal risk)
clinical investigation involves what? - Correct answer-a test article and one or
more human subjects
emergency use - Correct 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
True or False: As long as there is a potential for benefit, extremity of risk does not
matter - Correct answer-risk must be reasonable in relation to anticipated benefits
Examples of research that can utilize expedited review - Correct answer-research
involving no more than minimal risk, minor changes in approved research
Who has the power to disqualify an IRB? - Correct answer-the Commissioner,
notice is then sent to FDA
©COPYRIGHT 2025, ALL RIGHTS RESERVED 2
, When and why is joint review used? - Correct answer-for multi-institutional
studies to avoid duplication of effort
IEC - Correct answer-Independent Ethics Committee, includes IRBs
IND Phase 1 - Correct 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 3 - Correct 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? - Correct answer-30-day intervals prior to implementation
IP must provide what in protocol? - Correct answer--drug substance and formula
-effects on animals and humans
-safety and effectiveness
-possible risks and side effects
-pharma and toxicology reports (any in vitro and effects on fetus)
-radioactivity and absorption of dose
©COPYRIGHT 2025, ALL RIGHTS RESERVED 3
