SOCRA EXAM CERTIFICATION 2024-2025
ACTUAL EXAM 300 EXAM QUESTIOS AND
CORRECT DETAILED ANSWERS (100% VERIFIED
ANSWERS) |ALREADY GRADED A+
Terms in this set (125)
The IRB will determine if a 1. Adequate design
study is morally justified 2. a favorable risk/benefit ratio
and demonstrates what 3. equitable selection of subjects
key 4 items? 4. informed consent by subjects
1. Name/Address of investigator
2. Name and protocol #
3. Name and address of every facility where clinical
What all does the 1572
investigations will take place
contain?
4. Name/Address of any clinical lab
5. Name/Address of IRB
6. A commitment by the investigator
Failure to follow protocol, Deviations, Inadequate
Common Deficienceis of
record keeping, Inadequate accountability, ICF
FDA inspections
issues/subject protections
Office For Human Research Protections.
1. Protects volunteers in research conducted
OHRP
supported by US Dept. of Health and Human Services
2. Usually inspects IRBs
Affirmative decision of IRB that clinical trial has been
Definition of IRB approval reviewed and may be conducted at the institution site
with in constraints set forth by IRB, institution and GCP
, 1. Assure Protection of Human subjects, rights, and
well being
What is the Role/Purpose
2. Determine if research is a benefit to participants,
of IRB
does not cause harm, and promotes good clinical
practice
All noxious and unintended responses to a
Adverse Drug Reaction medicine/product related to any dose. Relationship
(ADR) between medicinal product and AE's is a reasonable
possibility. (the relationship cannot be ruled out)
Overall goals:
1. It is the structure of any scientific work. It gives
direction and systematizes the research.
Discuss the basics of study
Correlative Studies:
design?
1.Observational
2.Cohort
3.Cross sectional
Investigational Device Exemption. It permits a device
that otherwise would be required to comply with a
What is an IDE? performance standard or to have pre-market
approval to be shipped lawfully for the purpose of
conducting investigations of that device.
It is independent of and separate from routine
monitoring or quality control functions, should be
What is the purpose of an
used to evaluate trial conduct and compliance with
audit?
the protocol SOP's, GCP, and the applicable
regulatory requirements.
IDE must be submitted.
1.Implant or serious risk to health, safety, well-being
2.Supports/sustains human life
Significant Risk Device
3.Importance for diagnosis, treatment, or curing
diseases. Could be class II or class III. IRB makes
determination when FDA hasn't already.
, 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.
Criteria for IRB Approval
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 90 Days
IRB revise its registration
information?
1. Name/Address of IRB
What should sponsor
2. Statement from IRB that it is organized and
obtain from investigator
complies with GCP
regarding IRB?
3. Documented approval of ICS and Protocol
Investigators: 2 years after marketing applications
approval or 2 years after investigation is discontinued
and FDA is notified.
Record Keeping
Sponsor: Should maintain all sponsor specific docs for
at least 2 years after they discontinue development.
IRB: 3 years after completion of research.
If a sponsor discontinues 2 years.
the clinical development
of an investigational
product (i.e.) for any or all
indications, routes of
admin, dosage forms) the
sponsor should maintain
all sponsor specific
essential documents for at
least how many years?
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