SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPLETE 150
QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS) ALREADY GRADED A+
The IRB will determine if a study is morally justified and
demonstrates what key 4 items? - CORRECT ANSWER >>>>1.
Adequate design
2. a favorable risk/benefit ratio
3. equitable selection of subjects
4. informed consent by subjects
What all does the 1572 contain? - CORRECT ANSWER >>>>1.
Name/Address of investigator
2. Name and protocol #
3. Name and address of every facility where clinical
investigations will take place
4. Name/Address of any clinical lab
5. Name/Address of IRB
6. A commitment by the investigator
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Common Deficienceis of FDA inspections - CORRECT
ANSWER >>>>Failure to follow protocol, Deviations,
Inadequate record keeping, Inadequate accountability, ICF
issues/subject protections
OHRP - CORRECT ANSWER >>>>Office For Human Research
Protections.
1. Protects volunteers in research conducted supported by
US Dept. of Health and Human Services
2. Usually inspects IRBs
Definition of IRB approval - CORRECT ANSWER
>>>>Affirmative decision of IRB that clinical trial has been
reviewed and may be conducted at the institution site with
in constraints set forth by IRB, institution and GCP
What is the Role/Purpose of IRB - CORRECT ANSWER >>>>1.
Assure Protection of Human subjects, rights, and well being
2. Determine if research is a benefit to participants, does
not cause harm, and promotes good clinical practice
Adverse Drug Reaction (ADR) - CORRECT ANSWER >>>>All
noxious and unintended responses to a medicine/product
related to any dose. Relationship between medicinal
product and AE's is a reasonable possibility. (the
relationship cannot be ruled out)
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Discuss the basics of study design? - CORRECT ANSWER
>>>>Overall goals:
1. It is the structure of any scientific work. It gives direction
and systematizes the research.
Correlative Studies:
1.Observational
2.Cohort
3.Cross sectional
What is an IDE? - CORRECT ANSWER >>>>Investigational
Device Exemption. It permits a device that otherwise would
be required to comply with a performance standard or to
have pre-market approval to be shipped lawfully for the
purpose of conducting investigations of that device.
What is the purpose of an audit? - CORRECT ANSWER >>>>It
is independent of and separate from routine monitoring or
quality control functions, should be used to evaluate trial
conduct and compliance with the protocol SOP's, GCP, and
the applicable regulatory requirements.
Significant Risk Device - CORRECT ANSWER >>>>IDE must be
submitted.
1.Implant or serious risk to health, safety, well-being
2.Supports/sustains human life
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3.Importance for diagnosis, treatment, or curing diseases.
Could be class II or class III. IRB makes determination when
FDA hasn't already.
Criteria for IRB Approval - CORRECT ANSWER >>>>1. Risks to
subjects are minimized
2.Risks are reasonable in relation to benefits.
3. Selection of subjects is equitable.
4.ICF is obtained from each subject or LAR.
5.ICF is appropriately documented.
6.Research plan includes monitor data collected to ensure
subject safety
7.Adequate protection of privacy and confidentiality of data
-> additional safeguards for vulnerable populations.
How many days must the IRB revise its registration
information? - CORRECT ANSWER >>>>90 Days
What should sponsor obtain from investigator regarding
IRB? - CORRECT ANSWER >>>>1. Name/Address of IRB
2. Statement from IRB that it is organized and complies with
GCP
3. Documented approval of ICS and Protocol
Record Keeping - CORRECT ANSWER >>>>Investigators: 2
years after marketing applications approval or 2 years after
investigation is discontinued and FDA is notified.
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