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SOCRA REAL EXAM AND STUDY GUIDE LATEST , 200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED A+ Significant payments of other sorts (SPOOS) of this amount and duration must be reported as disclosable financial interests$28.49
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SOCRA REAL EXAM AND STUDY GUIDE LATEST , 200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED A+ Significant payments of other sorts (SPOOS) of this amount and duration must be reported as disclosable financial interests
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SOCRA REAL
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SOCRA REAL
SOCRA REAL EXAM AND STUDY GUIDE LATEST , 200 QUESTIONS AND CORRECT ANSWERS//ALREADY GRADED A+
Significant payments of other sorts (SPOOS) of this amount and duration must be reported as disclosable financial interests
SOCRA REAL EXAM AND STUDY GUIDE LATEST , 200 QUESTIONS AND CORRECT ANSWERS//AL...
SOCRA REAL EXAM AND STUDY GUIDE LATEST
2024-2025, 200 QUESTIONS AND CORRECT
ANSWERS//ALREADY GRADED A+
Significant payments of other sorts (SPOOS) of this amount and duration must be reported as
disclosable financial interests:
A. Of $25,000 or more during the duration of the study
B. Of $50,000 or more during the duration of the study
C. Of $25,000 or more during the time the clinical investigator is carrying out the study and for
one year following completion of the study
Of any amount - ANSWER-C. Of $25,000 or more
during the time the clinical investigator is carrying out
the study and for one year following completion of the
study
Which FDA Form is used for Mandatory Reporting of Adverse Events and Product Problems?
A. Form 3455
B. Form 3500
C. Form 3500A
D. Form 1572 - ANSWER-C. Form 3500A
Disclosure: Financial Interests and Arrangements of Clinical Investigators would also be known
as:
A. Form 3455
B. Form 3454
C. Form 3500
D. Form 1572 - ANSWER-A. Form 3455
Certification: Financial Interest and arrangements of Clinical Investigators would also be known
as:
A. Form 3455
B. Form 3454
C. Form 3500
,D. Form 1572 - ANSWER-B. Form 3454
The investigator's financial interests with the pharmaceutical company (sponsor) or to the
outcome of the clinical investigation is reported directly to the FDA by:
A. The investigator
B. The IRB
C. The investigator's institution
D. The applicant - ANSWER-D. The applicant
The Form FDA 3455 is completed by
A. The applicant
B. The FDA
C. The investigator
D. The study coordinator - ANSWER-A. The applicant
The Form FDA 3500 is used for
A. Financial Disclosures
B. Inspections
C. Voluntary reporting
D. Mandatory reporting - ANSWER-C. Voluntary reporting
FDA Form 3500A is used for
A. Financial Disclosures
B. Inspections
C. Voluntary reporting
D. Mandatory reporting - ANSWER-D. Mandatory reporting
Clinical Investigators financial disclosures are submitted on
A. Form FDA 1572
,B. Form FDA 3454
C. Form FDA 3500A
D. Form FDA 3455 - ANSWER-D. Form FDA 3455
The FDA requires retention of investigational drug study records for?
A. Indefinitely
B. At least three years after the study has ended at the site
C. At least two years after the investigational drug's approval by the FDA
D. At least one year after the last subject completes all study interventions - ANSWER-C. At
least two years after the investigational drug's approval by the FDA
According to ICH guidelines, how long must an IRB retain its records for each research project?
A. 2 years after completion of the trial
B. 3 years after completion of the trial
C. 3 years after the marketing application is approved
D. 5 years after the completion of the trial - ANSWER-B. 3 years after completion of the trial
According to FDA regulation, how long must an IRB retain records?
A. 2 years after the study closes at the site
B. 3 years after completion of the research
C. 3 years after the marketing application is approved
D. According to the protocol - ANSWER-B. 3 years after completion of the research
According to ICH GCP how long should investigators maintain study records?
A. 3 years after completion of the study
B. 2 years after the study is closed at the site
C. 2 years following the last approval of a marketing application
D. 3 years after the investigation is discontinued - ANSWER-C. 2 years following the last
approval of a marketing application
, Which of the following best describes when the majority of case report form (CRF) data are
verified against source record information?
A. Site initiation visit
B. Termination site visit
C. Periodic site visits
D. Prestudy site visit - ANSWER-C. Periodic site visits
Which of the following should take place during periodic monitoring visits?
A. Analysis of data
B. Determination of adverse event causality
C. Identification of protocol violations
D. Initial assessment of the site's potential to enroll research subjects - ANSWER-C.
Identification of protocol violations
The overall goal of monitoring, audits and inspection activities is to:
A. Ensure the protection of human research subjects and data integrity.
B. Manage conflict of interest.
C. Review research related publications.
D. Resolve disputes between the sponsor and the investigators. - ANSWER-A. Ensure the
protection of human research subjects and data integrity.
According to ICH E6 GCP, an "Audit" is defined as:
A. An official review of documents, facilities, records, and any other resources related to a
clinical trial.
B. The act of overseeing the progress of a clinical trial.
C. A systematic and independent examination of trial-related activities and documents.
D. A institutional self-assessment - ANSWER-C. A systematic and independent examination
of trialrelated activities and documents.
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