CCRP UPDATED ACTUAL Exam Questions and CORRECT Answers
( Edition) | Solved Exam Pack | 100% Pass
Question 1.
IRB/IEC
Correct Answer: In accordance with regulations, before implementation, the
informed consent document must be approved by the:
Question 2.
ICH GCP Guideline
Correct Answer: 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
Question 3.
Form 1572
Correct Answer: 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
Question 4.
Who monitors the progress of all clinical trial investigations being conducted under an
IND?
Correct Answer: The sponsor
Question 5.
Statement of ethical principles for medical research involving human participants,
including research using identifiable human material or data (WMA)
Correct Answer: Declaration of Helsinki
Question 6.
Good Clinical Practices (GCP)
Correct Answer: The international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the
participation of human subjects
Question 7.
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.
Correct Answer: 5 working days
Question 8.
What is the minimum number of IRB members?
Correct Answer: 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
Question 9.
Short-Form Consent
Correct Answer: 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
Question 10.
When can IRB requirements be waived?
Correct Answer: 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
Question 11.
When is it unnecessary to request a waiver of IRB requirements?
Correct Answer: 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
Question 12.
How long must an IRB retain records for?
Correct Answer: 3 years after completion of research
Question 13.
Who determines that requirements for permission by parents/guardians, and assent by
children are met?
Correct Answer: The IRB
( Edition) | Solved Exam Pack | 100% Pass
Question 1.
IRB/IEC
Correct Answer: In accordance with regulations, before implementation, the
informed consent document must be approved by the:
Question 2.
ICH GCP Guideline
Correct Answer: 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
Question 3.
Form 1572
Correct Answer: 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
Question 4.
Who monitors the progress of all clinical trial investigations being conducted under an
IND?
Correct Answer: The sponsor
Question 5.
Statement of ethical principles for medical research involving human participants,
including research using identifiable human material or data (WMA)
Correct Answer: Declaration of Helsinki
Question 6.
Good Clinical Practices (GCP)
Correct Answer: The international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the
participation of human subjects
Question 7.
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.
Correct Answer: 5 working days
Question 8.
What is the minimum number of IRB members?
Correct Answer: 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
Question 9.
Short-Form Consent
Correct Answer: 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
Question 10.
When can IRB requirements be waived?
Correct Answer: 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
Question 11.
When is it unnecessary to request a waiver of IRB requirements?
Correct Answer: 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
Question 12.
How long must an IRB retain records for?
Correct Answer: 3 years after completion of research
Question 13.
Who determines that requirements for permission by parents/guardians, and assent by
children are met?
Correct Answer: The IRB
