CCRP EXAM FINAL PAPER VERIFIED QUESTIONS ACCURATE SOLUTIONS
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
IRB/IEC
Answer:
In accordance with regulations, before implementation, the informed consent document must be
approved by the:
Question:
ICH GCP Guideline
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:
Form 1572
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:
Who monitors the progress of all clinical trial investigations being conducted under an IND?
Answer:
The sponsor
Question:
, Statement of ethical principles for medical research involving human participants, including
research using identifiable human material or data (WMA)
Answer:
Declaration of Helsinki
Question:
Good Clinical Practices (GCP)
Answer:
The international ethical and scientific quality standard for designing, conducting, recording and
reporting trials that involve the participation of human subjects
Question:
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.
Answer:
5 working days
Question:
What is the minimum number of IRB members?
Answer:
5 members
Question:
IRB Committee should consist of:
Answer:
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
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
IRB/IEC
Answer:
In accordance with regulations, before implementation, the informed consent document must be
approved by the:
Question:
ICH GCP Guideline
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:
Form 1572
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:
Who monitors the progress of all clinical trial investigations being conducted under an IND?
Answer:
The sponsor
Question:
, Statement of ethical principles for medical research involving human participants, including
research using identifiable human material or data (WMA)
Answer:
Declaration of Helsinki
Question:
Good Clinical Practices (GCP)
Answer:
The international ethical and scientific quality standard for designing, conducting, recording and
reporting trials that involve the participation of human subjects
Question:
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.
Answer:
5 working days
Question:
What is the minimum number of IRB members?
Answer:
5 members
Question:
IRB Committee should consist of:
Answer:
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
