SOCRA EXAM PRACTICE QUESTIONS AND
DETAILED SOLUTIONS
◉ What does 21CFR50 section 812 regulate?
Answer: Investigational Device Exemptions
◉ There are 8 ICH GCP guidelines. The first is the glossary and the
second is the principles of GCP. What are the other 6 guidelines?
Answer: 3. IRB/IEC
4. Investigator
5. Sponsor
6. Protocol and protocol amendments
7. Investigator's Brochure
8. Essential documents
◉ There are ___________ principles of ICH GCP
Answer: 13
◉ In 21CFR50.24, when there has been exception from informed
consent for emergency research, the proposed investigational plan
must be based on __________________________________ in order for this
exception to occur?
,Answer: Scientific Evidence
◉ What is the name of FDA Form 482?
Answer: Notice of Inspection
◉ True or False? The rights, safety and well-being of the trial
subjects are the most important consideration and should prevails
over the interests of science and society
Answer: True
◉ All principles of GCP are conducted in accordance with
_________________________________________________________.
Answer: The Declaration of Helsinki
◉ True of False? ICH GCP principle 2.10 gives guidance about
informed consent
Answer: False. This principle covers guidelines referring to clinical
trial information (data) and how it should be accurate in reporting,
interpretation and verification. Principle 2.9 gives guidance about
informed consent.
◉ What is the name of FDA Form 3455?
Answer: Disclosures: Financial interests and arrangements of
clinical investigators
, ◉ In 21CFR50, subpart B, there are _______ basic elements of
informed consent.
Answer: 8
◉ How many members of an IRB are required to have a non-
scientific background
Answer: At least 1 member
◉ What is the name of FDA Form 1572?
Answer: Statement of Investigator
◉ The Assent of a child is not necessary when these 2 conditions are
present:
Answer: 1. The capability of some or all of the children is so limited
that they cannot be reasonably consulted
2. The intervention holds a prospect of direct benefit that is
important to the health or well being of the child and is only
available in the context of clinical investigation
◉ What is the name of FDA Form 3500?
Answer: For voluntary reporting of an adverse event and product
problems
DETAILED SOLUTIONS
◉ What does 21CFR50 section 812 regulate?
Answer: Investigational Device Exemptions
◉ There are 8 ICH GCP guidelines. The first is the glossary and the
second is the principles of GCP. What are the other 6 guidelines?
Answer: 3. IRB/IEC
4. Investigator
5. Sponsor
6. Protocol and protocol amendments
7. Investigator's Brochure
8. Essential documents
◉ There are ___________ principles of ICH GCP
Answer: 13
◉ In 21CFR50.24, when there has been exception from informed
consent for emergency research, the proposed investigational plan
must be based on __________________________________ in order for this
exception to occur?
,Answer: Scientific Evidence
◉ What is the name of FDA Form 482?
Answer: Notice of Inspection
◉ True or False? The rights, safety and well-being of the trial
subjects are the most important consideration and should prevails
over the interests of science and society
Answer: True
◉ All principles of GCP are conducted in accordance with
_________________________________________________________.
Answer: The Declaration of Helsinki
◉ True of False? ICH GCP principle 2.10 gives guidance about
informed consent
Answer: False. This principle covers guidelines referring to clinical
trial information (data) and how it should be accurate in reporting,
interpretation and verification. Principle 2.9 gives guidance about
informed consent.
◉ What is the name of FDA Form 3455?
Answer: Disclosures: Financial interests and arrangements of
clinical investigators
, ◉ In 21CFR50, subpart B, there are _______ basic elements of
informed consent.
Answer: 8
◉ How many members of an IRB are required to have a non-
scientific background
Answer: At least 1 member
◉ What is the name of FDA Form 1572?
Answer: Statement of Investigator
◉ The Assent of a child is not necessary when these 2 conditions are
present:
Answer: 1. The capability of some or all of the children is so limited
that they cannot be reasonably consulted
2. The intervention holds a prospect of direct benefit that is
important to the health or well being of the child and is only
available in the context of clinical investigation
◉ What is the name of FDA Form 3500?
Answer: For voluntary reporting of an adverse event and product
problems
