CCRP Exam Questions and Answers (2026
Edition) | Solved Exam Pack | 100% Pass
• IRB/IEC -✓✓In accordance with regulations, before implementation,
the informed consent document must be approved by the:
• ICH GCP Guideline -✓✓Provide a unified standard for the European
Union (EU), Japan, and the United States to facilitate the mutual
acceptance of clinical data by the regulatory authorities in these
jurisdictions
• Form 1572 -✓✓an agreement signed by the
investigator to provide certain information to the sponsor and assure that
he/she will comply with FDA regulations related to the conduct of a
clinical investigation of an IND
• Who monitors the progress of all clinical trial investigations being
conducted under an IND? -✓✓The sponsor
• Statement of ethical principles for medical research involving human
participants, including research using identifiable human material or data
(WMA) -✓✓Declaration of Helsinki
• Good Clinical Practices (GCP) -✓✓The international ethical and
scientific quality standard for designing, conducting, recording and
reporting trials that involve the participation of human subjects
• Once the sponsor evaluates data from a clinical trial and decides the
drug presents an immeasurable and significant risk to the subjects; the
sponsor has _______ to discontinue the study. -✓✓5 working days
• What is the minimum number of IRB members? -✓✓5 members
, • IRB Committee should consist of: -✓✓At least:
1 member with primary concerns in scientific areas
1 with primary concerns in non-scientific areas
1 member who is not affiliated with the institution
• Short-Form Consent -✓✓when a potential participant in a study doesn't
speak English and there isn't enough time to translate the consent
document. It's also used when the participant's legally authorized
representative (LAR) doesn't speak English
• When can IRB requirements be waived? -✓✓FDA may waive any of
the IRB
requirements for specific research activities or for classes of research
activities otherwise covered by the IRB regulations, but FDA believes
that this waiver provision should be used only when alternative
mechanisms for ensuring protection of the rights and welfare of human
subjects are acceptable
• When is it unnecessary to request a waiver of IRB requirements? -
✓✓A sponsor does not need to apply prospectively for a waiver of the
IRB requirements for the emergency use of a test article provided that
such use is reported to the IRB within 5 working
days
• How long must an IRB retain records for? -✓✓3 years after completion
of research
• Who determines that requirements for permission by
parents/guardians, and assent by children are met? -✓✓The IRB
• The sponsor must notify FDA and all participating investigators in an
IND safety report within ______ days after the sponsor determines that
the information qualifies for reporting. -✓✓15 calendar days
Edition) | Solved Exam Pack | 100% Pass
• IRB/IEC -✓✓In accordance with regulations, before implementation,
the informed consent document must be approved by the:
• ICH GCP Guideline -✓✓Provide a unified standard for the European
Union (EU), Japan, and the United States to facilitate the mutual
acceptance of clinical data by the regulatory authorities in these
jurisdictions
• Form 1572 -✓✓an agreement signed by the
investigator to provide certain information to the sponsor and assure that
he/she will comply with FDA regulations related to the conduct of a
clinical investigation of an IND
• Who monitors the progress of all clinical trial investigations being
conducted under an IND? -✓✓The sponsor
• Statement of ethical principles for medical research involving human
participants, including research using identifiable human material or data
(WMA) -✓✓Declaration of Helsinki
• Good Clinical Practices (GCP) -✓✓The international ethical and
scientific quality standard for designing, conducting, recording and
reporting trials that involve the participation of human subjects
• Once the sponsor evaluates data from a clinical trial and decides the
drug presents an immeasurable and significant risk to the subjects; the
sponsor has _______ to discontinue the study. -✓✓5 working days
• What is the minimum number of IRB members? -✓✓5 members
, • IRB Committee should consist of: -✓✓At least:
1 member with primary concerns in scientific areas
1 with primary concerns in non-scientific areas
1 member who is not affiliated with the institution
• Short-Form Consent -✓✓when a potential participant in a study doesn't
speak English and there isn't enough time to translate the consent
document. It's also used when the participant's legally authorized
representative (LAR) doesn't speak English
• When can IRB requirements be waived? -✓✓FDA may waive any of
the IRB
requirements for specific research activities or for classes of research
activities otherwise covered by the IRB regulations, but FDA believes
that this waiver provision should be used only when alternative
mechanisms for ensuring protection of the rights and welfare of human
subjects are acceptable
• When is it unnecessary to request a waiver of IRB requirements? -
✓✓A sponsor does not need to apply prospectively for a waiver of the
IRB requirements for the emergency use of a test article provided that
such use is reported to the IRB within 5 working
days
• How long must an IRB retain records for? -✓✓3 years after completion
of research
• Who determines that requirements for permission by
parents/guardians, and assent by children are met? -✓✓The IRB
• The sponsor must notify FDA and all participating investigators in an
IND safety report within ______ days after the sponsor determines that
the information qualifies for reporting. -✓✓15 calendar days
