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SOCRA CCRP EXAM NEWEST 2025/2026 ACTUAL EXAM 100
QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES
/SOCRA CCRP EXAM ACTUAL EXAM QUESTIONS AND CORRECT
DETAILED ANSWERS WITH RATIONALES |A+GRADE
The 3 fundamental ethical principles for human subjects in research are:
A) Respect for persons, beneficence, justice B) Respect for subjects, their safety and their
time C) Respect for sponsor, IRB and FDA guidelines D) Respect for data, welfare and
discovery - ......ANSWER........A) Respect for persons, beneficence, justice
The clinical investigator will update the financial disclosure information if any relevant
changes occur during the investigation's course and for _______ following the study's
completion.
A) 6 months B) 1 year C) 2 years D) 5 years - ......ANSWER........B) 1 Year
The Code of Federal Regulations that applies to Institutional Review Boards is:
A) 45CFR46 B) 21CFR312 C) 21CFR50 D) 21CFR56 - ......ANSWER........D) 21 CFR 56
The contents of a Protocol should generally contain:
A) Trial objectives and purpose B) Assessment of efficacy C) Data handling and record
keeping D) All of the above E) Only A & C - ......ANSWER........D) All of the above
The Food and Drug Administration (FDA) conducts drug risk assessment by considering
which of the following?
A) There are enough people needing the drug. B) The benefits of the drug outweigh the
known and potential risk of the drug C) The side-effect of the drug is measurable D) The
sponsor is able to financially support the research - ......ANSWER........B) The benefits of
the drug outweigh the known and potential risk of the drug
The international ethical and scientific quality standard for designing, conducting,
recording and reporting trials that involve the participation of human subjects is known as:
, 2 of 10
A) The ICH B) Good Clinical Practices (GCP) C) The Declaration of Helsinki D) Fundamental
Ethical Principles (FEP) - ......ANSWER........B) Good Clinical Practices (GCP)
The responsibility for ensuring that the investigator understands a clinical trial lies with
which individual/or organization?
A) FDA B) IRB C) Sponsor D) Coordinator - ......ANSWER........C) Sponsor
The World Medical Association (WMA) ethical principles for medical research involving
human subjects are called:
A) The Belmont Report B) The National Research Act C) The Nuremberg Code D) The
Declaration of Helsinki - ......ANSWER........D) The Declaration of Helsinki
This form is used for the mandatory reporting of serious adverse events:
A) 1571 B) 1572 C) 3500 D) 3500A - ......ANSWER........D) 3500A
This form is used for the voluntary reporting of adverse events and product problems:
A) 1571 B) 1572 C) 3500 D) 3500A - ......ANSWER........C) 3500
Reminder: 3500 is for voluntary; 3500A is for mandatory
True or False:
A Clinical Hold is an order by FDA to the investigator to suspend or stop ongoing
investigations. - ......ANSWER........False
Explanation: A Clinical Hold is an order by FDA to the sponsor (not investigator) to suspend
or stop ongoing investigations.
True or False:
A Short Form informed consent is a written summary of the ICF that is not to exceed one
page. - ......ANSWER........False
Explanation: 21 CFR 50.27
True or False:
An IND is always required before using an investigational new drug.
- ......ANSWER........False
SOCRA CCRP EXAM NEWEST 2025/2026 ACTUAL EXAM 100
QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES
/SOCRA CCRP EXAM ACTUAL EXAM QUESTIONS AND CORRECT
DETAILED ANSWERS WITH RATIONALES |A+GRADE
The 3 fundamental ethical principles for human subjects in research are:
A) Respect for persons, beneficence, justice B) Respect for subjects, their safety and their
time C) Respect for sponsor, IRB and FDA guidelines D) Respect for data, welfare and
discovery - ......ANSWER........A) Respect for persons, beneficence, justice
The clinical investigator will update the financial disclosure information if any relevant
changes occur during the investigation's course and for _______ following the study's
completion.
A) 6 months B) 1 year C) 2 years D) 5 years - ......ANSWER........B) 1 Year
The Code of Federal Regulations that applies to Institutional Review Boards is:
A) 45CFR46 B) 21CFR312 C) 21CFR50 D) 21CFR56 - ......ANSWER........D) 21 CFR 56
The contents of a Protocol should generally contain:
A) Trial objectives and purpose B) Assessment of efficacy C) Data handling and record
keeping D) All of the above E) Only A & C - ......ANSWER........D) All of the above
The Food and Drug Administration (FDA) conducts drug risk assessment by considering
which of the following?
A) There are enough people needing the drug. B) The benefits of the drug outweigh the
known and potential risk of the drug C) The side-effect of the drug is measurable D) The
sponsor is able to financially support the research - ......ANSWER........B) The benefits of
the drug outweigh the known and potential risk of the drug
The international ethical and scientific quality standard for designing, conducting,
recording and reporting trials that involve the participation of human subjects is known as:
, 2 of 10
A) The ICH B) Good Clinical Practices (GCP) C) The Declaration of Helsinki D) Fundamental
Ethical Principles (FEP) - ......ANSWER........B) Good Clinical Practices (GCP)
The responsibility for ensuring that the investigator understands a clinical trial lies with
which individual/or organization?
A) FDA B) IRB C) Sponsor D) Coordinator - ......ANSWER........C) Sponsor
The World Medical Association (WMA) ethical principles for medical research involving
human subjects are called:
A) The Belmont Report B) The National Research Act C) The Nuremberg Code D) The
Declaration of Helsinki - ......ANSWER........D) The Declaration of Helsinki
This form is used for the mandatory reporting of serious adverse events:
A) 1571 B) 1572 C) 3500 D) 3500A - ......ANSWER........D) 3500A
This form is used for the voluntary reporting of adverse events and product problems:
A) 1571 B) 1572 C) 3500 D) 3500A - ......ANSWER........C) 3500
Reminder: 3500 is for voluntary; 3500A is for mandatory
True or False:
A Clinical Hold is an order by FDA to the investigator to suspend or stop ongoing
investigations. - ......ANSWER........False
Explanation: A Clinical Hold is an order by FDA to the sponsor (not investigator) to suspend
or stop ongoing investigations.
True or False:
A Short Form informed consent is a written summary of the ICF that is not to exceed one
page. - ......ANSWER........False
Explanation: 21 CFR 50.27
True or False:
An IND is always required before using an investigational new drug.
- ......ANSWER........False
