SOCRA PRACTICE REAL EXAM QUESTIONS
AND REAL ANSWERS 2024-2025 LATEST
version//A GRADE WITH 80% PASSING RATE
Who monitors the progress of all clinical trial investigations being conducted under its IND? -
ANSWER-The Sponsor
.
A(n) _______________ is a printed, optical or electronic document designed to record all of the
protocol required information to be reported to the sponsor on each trial subject. - ANSWER-Case
Report Form- CRF
________________ is permission to examine, analyze, verify, and reproduce any records and reports
that are important to evaluation of a clinical trial. - ANSWER-Direct Access
The form _____________ is used for investigational new drugs (or IND). - ANSWER-1571
Under 21CFR312, this form is the statement of the investigator of a clinical trial. - ANSWER-1572
What is the FDA form 3455? - ANSWER-Disclosure statement for financial disclosure of clinical
investigators who have disclosable interests
The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR_____
- ANSWER-312
A sponsor my transfer responsibility for any of all of the obligations to a _______. - ANSWER-CRO,
Contract research organization
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. - ANSWER-one
year.
.
The contract research organization shall select a monitor that is _______. - ANSWER-Qualified by
experience.
, Qualified by training.
Before the investigation begins, the sponsor shall give each participation clinical investigator a/an
_____. - ANSWER-IB, investigator's brochure
A ________ lists the investigator's education, training, and experience that qualifies the investigator
as an expert in the clinical investigation of the drug for the use under investigation.
A. Curriculum vitae
B. Letter from a fellow investigator
C. Statement of qualifications of the investigator
D. A and C - ANSWER-D. A and C
A drug's safety is determined by which of the following criteria?
A. The Food and Drug Administration's (FDA) review of source documentation at a clinical site
B. The absence of harmful side effects on the individuals exposed so far.
C. The dose at which no side effects are reported.
D. All of the above - ANSWER-C. A. The dose at which no side effects are reported.
Which of the following design methods would best be used for a study interested in keeping both the
subject and the investigator (or site staff) from knowing which treatment the subject was receiving?
A. Double Blinded
B. Interpretive Bias
C. Bias Reduction
D. Phase 1 - ANSWER-A. Double Blinded
True or False?
When a short form is used for informed consent, the witness must sign both the short form and the
summary? - ANSWER-True
An investigator shall submit a final report to the sponsor and the reviewing IRB within - ANSWER-3
months after termination or completion of the investigation or the investigator's part of the
investigation.
AND REAL ANSWERS 2024-2025 LATEST
version//A GRADE WITH 80% PASSING RATE
Who monitors the progress of all clinical trial investigations being conducted under its IND? -
ANSWER-The Sponsor
.
A(n) _______________ is a printed, optical or electronic document designed to record all of the
protocol required information to be reported to the sponsor on each trial subject. - ANSWER-Case
Report Form- CRF
________________ is permission to examine, analyze, verify, and reproduce any records and reports
that are important to evaluation of a clinical trial. - ANSWER-Direct Access
The form _____________ is used for investigational new drugs (or IND). - ANSWER-1571
Under 21CFR312, this form is the statement of the investigator of a clinical trial. - ANSWER-1572
What is the FDA form 3455? - ANSWER-Disclosure statement for financial disclosure of clinical
investigators who have disclosable interests
The Code of Federal Regulations that applies to Investigational New Drug Applications is 21CFR_____
- ANSWER-312
A sponsor my transfer responsibility for any of all of the obligations to a _______. - ANSWER-CRO,
Contract research organization
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. - ANSWER-one
year.
.
The contract research organization shall select a monitor that is _______. - ANSWER-Qualified by
experience.
, Qualified by training.
Before the investigation begins, the sponsor shall give each participation clinical investigator a/an
_____. - ANSWER-IB, investigator's brochure
A ________ lists the investigator's education, training, and experience that qualifies the investigator
as an expert in the clinical investigation of the drug for the use under investigation.
A. Curriculum vitae
B. Letter from a fellow investigator
C. Statement of qualifications of the investigator
D. A and C - ANSWER-D. A and C
A drug's safety is determined by which of the following criteria?
A. The Food and Drug Administration's (FDA) review of source documentation at a clinical site
B. The absence of harmful side effects on the individuals exposed so far.
C. The dose at which no side effects are reported.
D. All of the above - ANSWER-C. A. The dose at which no side effects are reported.
Which of the following design methods would best be used for a study interested in keeping both the
subject and the investigator (or site staff) from knowing which treatment the subject was receiving?
A. Double Blinded
B. Interpretive Bias
C. Bias Reduction
D. Phase 1 - ANSWER-A. Double Blinded
True or False?
When a short form is used for informed consent, the witness must sign both the short form and the
summary? - ANSWER-True
An investigator shall submit a final report to the sponsor and the reviewing IRB within - ANSWER-3
months after termination or completion of the investigation or the investigator's part of the
investigation.
