PRACTICE QUESTIONS FOR SOCRA EXAM
QUESTIONS WITH 100% CORRECT ANSWERS.
Which of the following is a disclosure of financial interests form? ANS -
Which of the following is a certification of financial interest form? ANS -
If the investigator did have financial arrangement with the sponsor, he/she would submit the
following form: ANS -
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial ANS -
Investigational New Drug Application
In the top right corner, form have OMB number. What does it stand for? ANS -
The form, which is submitted to the FDA to report an Adverse Event is ANS -
Medical device adverse events/problems are reported via a form: ANS -
What is FDA form 1571? ANS -
21 CFR 312 deals with ANS -
Investigational new drug means ANS - A new drug or biological drug that is used in a clinical
investigation
The immediate package of an investigational new drug intended for human use shall bear a
label wit the statement ANS -
Which of the following is not listed on FDA form 1571: ANS - a. name, address, phone
number of the sponsor
b. a commitment not to start the clinical investifation until the InD is in effect
c. identification of the phase of the trail
d. approved informed consent document
, "Any adverse drug experience that places the patient or subject, in the view of the investigator,
at immediate risk of death from the reaction as it occurred" Is... ANS - a. serious adverse
drug experience
b. life threatening adverse drug experience
c. none of the above
What are the three main basic ethical principles of the Belmont Report? ANS - 1. Respect for
Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? ANS - 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What phrase of a drug trial usually includes hundreds to thousands of volunteers? ANS -
Phase 3: These studies gather more information about safety and effectiveness, study different
populations and different dosages, and uses the drug in combination with other drugs.
What is a drug as defined by the FDA? ANS - A drug is an product that is intended for use in
the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to
affect the structure or any function of the body.
What is Phase 1 of a clinical trial? ANS - 20-80: Typical number of healthy volunteers used in
Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a clinical trial? ANS - 100s: Typical number of patients used in Phase 2;
this phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? ANS - 1000's :Typical number of patients used in Phase. 3.
These studies gather more information about safety and effectiveness, study different
populations and different dosages, and uses the drug in combination with other drugs.
What is Phase 4 of a clinical trial? ANS - Post Marketing: Because it's not possible to predict
all of a drug's effects during clinical trials, monitoring safety issues after drugs get on the
market is critical. The role of FDA's post-marketing safety system is to detect serious
unexpected adverse events and take definitive action when needed.
The main concept of 21 CFR 50 is ANS -
QUESTIONS WITH 100% CORRECT ANSWERS.
Which of the following is a disclosure of financial interests form? ANS -
Which of the following is a certification of financial interest form? ANS -
If the investigator did have financial arrangement with the sponsor, he/she would submit the
following form: ANS -
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial ANS -
Investigational New Drug Application
In the top right corner, form have OMB number. What does it stand for? ANS -
The form, which is submitted to the FDA to report an Adverse Event is ANS -
Medical device adverse events/problems are reported via a form: ANS -
What is FDA form 1571? ANS -
21 CFR 312 deals with ANS -
Investigational new drug means ANS - A new drug or biological drug that is used in a clinical
investigation
The immediate package of an investigational new drug intended for human use shall bear a
label wit the statement ANS -
Which of the following is not listed on FDA form 1571: ANS - a. name, address, phone
number of the sponsor
b. a commitment not to start the clinical investifation until the InD is in effect
c. identification of the phase of the trail
d. approved informed consent document
, "Any adverse drug experience that places the patient or subject, in the view of the investigator,
at immediate risk of death from the reaction as it occurred" Is... ANS - a. serious adverse
drug experience
b. life threatening adverse drug experience
c. none of the above
What are the three main basic ethical principles of the Belmont Report? ANS - 1. Respect for
Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? ANS - 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What phrase of a drug trial usually includes hundreds to thousands of volunteers? ANS -
Phase 3: These studies gather more information about safety and effectiveness, study different
populations and different dosages, and uses the drug in combination with other drugs.
What is a drug as defined by the FDA? ANS - A drug is an product that is intended for use in
the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to
affect the structure or any function of the body.
What is Phase 1 of a clinical trial? ANS - 20-80: Typical number of healthy volunteers used in
Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a clinical trial? ANS - 100s: Typical number of patients used in Phase 2;
this phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? ANS - 1000's :Typical number of patients used in Phase. 3.
These studies gather more information about safety and effectiveness, study different
populations and different dosages, and uses the drug in combination with other drugs.
What is Phase 4 of a clinical trial? ANS - Post Marketing: Because it's not possible to predict
all of a drug's effects during clinical trials, monitoring safety issues after drugs get on the
market is critical. The role of FDA's post-marketing safety system is to detect serious
unexpected adverse events and take definitive action when needed.
The main concept of 21 CFR 50 is ANS -
