SOCRA CCRP 2025 EXAM QUESTIONS

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SOCRA CCRP 2025 EXAM QUESTIONS

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -80 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: - Created the National Commission for the protection of Human Subjects

• This committee developed guidelines to ensure the research followed a set of basic

ethical principles

• These basic principles were identified by the committee over a 4 year time period and

resulted in the Belmont Report of 1979

Answer:

National Research Act 1974

Question 2: Do no harm

Maximize possible benefit and minimize possible harm

Answer:

Beneficence

Question 3: 10 Basic Principles of the Nuremberg Code of 1947

Answer:

• Voluntary consent of human subjects

• Results for good of society

• Designed and based on results of animal experimentation and knowledge of disease/condition under

study.

• Designed to avoid unnecessary physical and mental suffering.

• No experiments to be conducted when there is expectation of death or disabling injury

• Degree of risk should never exceed humanitarian importance of the problems to be solved by the

experiment

• Proper facilities provided to protect subject against injury, disability or death
• Experiment should be conducted only by scientifically qualified person
• Subject should be at liberty to end the experiment if he has reached the state where continuation

seems impossible

• Scientist in charge must be prepared to terminate the experiment if continuation of the experiment is

likely to result in injury, disability or death.

Question 4: FDA Form 1572

Answer:

Statement of Investigator Question 5: Within ______ after termination or completion of trial, submit a final report to the sponsor and IRB

Answer:

• months

Question 6: Applications of the Belmont Report

Answer:

Informed consent Assessment of risks / benefits Selection of subjects Question 7: The responsibility for ensuring that the investigator understand a clinical trial falls on...

Answer:

The Sponsor

Question 8: FDA has ______ to respond to a sponsor request to lift an IND hold

Answer:

30 days

Question 9: ICH

Answer:

International Council for Harmonization (CITI Training) ICH - unified standard for European Union, US and Japan. Developed using standard of the above plus Canada, Australia, and Nordic Nations & WHO

Question 10: An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well being of the trial subjects are protected.

Answer:

Good Clinical Practice (GCP)

Question 11: IRB Membership

Answer:

• 5 members, 1 scientific, 1 non-scientific and 1 non-affiliated
• Professional background and knowledge adequate to evaluation research
• Avoid all men or all women
• If IRB reviews vulnerable population research on a regular basis (i.e. prisoners) should have an expert

in that population

• No conflict of interest - member must recuse if has an interest in the research.

Question 12: IND Inactive Status

Answer:

IND can be placed inactive if no patients are enrolled for 2 years or all clinical actions are on hold for 1 year or more -Investigator notified -Drugs returned or destroyed -No annual report required If an IND is inactive for 5 years or more it may be terminated Question 13: Serious, unexpected adverse events that are not fatal or life threatening must be filed ASAP but no later than ______ after first knowledge by the sponsor.

Answer:

15 calendar days

Question 14: FDA Form 3455

Answer:

DISCLOSURE of financial interests and arrangements of clinical investigators

Question 15: New, untested or different

Answer:

Experimental Research

Question 16: For fatal or life threatening unexpected adverse events regulatory agencies should be notified ______ but no later than _______ after first knowledge by sponsor, followed by a completed report within ______.

Answer:

ASAP

• calendar days
• additional calendar days

Question 17: FDA Form 483

Answer:

Inspectional Observations

Question 18: The purpose of monitoring clinical trials is to verify that...

Answer:

The rights, safety and well-being of human subjects are protected Question 19: A sponsor shall notify all IRBs and investigators within ______ if there is a withdrawal of FDA approval

Answer:

• working days

Question 20: FDA will provide written documentation within ______ after FDA receives IND or IDE application.

Answer:

30 days

Question 21: GCP principles

Answer:

• Trials in accordance with ethical of Declaration of Helsinki

• Risk / benefit ratio prior to initiation of a trial. Benefits need to justify risk

• Rights, safety and well-being of subjects prevail over the interests of science and society

• Available info on an investigational product should be adequate to support the trial

• Trials should be scientifically sound and described in a detailed protocol.
• Trials conducted with IRB / IEC approval.
• Medical Care and decision always responsibility of physician