1
SOCRA Certification EXAM . Questions with correct
and verified Answers. GRADED A+.
The IRB will determine if a study is morally justified and demonstrates what key 4
items? - ...(ANSWERS)....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? - ...(ANSWERS)....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
Common Deficienceis of FDA inspections - ...(ANSWERS)....Failure to follow
protocol, Deviations, Inadequate record keeping, Inadequate accountability, ICF
issues/subject protections
OHRP - ...(ANSWERS)....Office For Human Research Protections.
1. Protects volunteers in research conducted supported by US Dept. of Health and
Human Services
2. Usually inspects IRBs
, 2
Definition of IRB approval - ...(ANSWERS)....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 - ...(ANSWERS)....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) - ...(ANSWERS)....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)
Discuss the basics of study design? - ...(ANSWERS)....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? - ...(ANSWERS)....Investigational Device Exemption. It permits a
device that otherwise would be required to comply with a performance standard
, 3
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? - ...(ANSWERS)....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 - ...(ANSWERS)....IDE must be submitted.
1.Implant or serious risk to health, safety, well-being
2.Supports/sustains human life
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 - ...(ANSWERS)....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.
, 4
How many days must the IRB revise its registration information? -
...(ANSWERS)....90 Days
What should sponsor obtain from investigator regarding IRB? - ...(ANSWERS)....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 - ...(ANSWERS)....Investigators: 2 years after marketing
applications approval or 2 years after investigation is discontinued and FDA is
notified.
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 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? -
...(ANSWERS)....2 years.
Can a clinical investigator submit an IDE? - ...(ANSWERS)....Yes. They can sponsor
their own study. They are considered a sponsor-investigator and must comply
with all responsibilities of both sponsor and investigator.
SOCRA Certification EXAM . Questions with correct
and verified Answers. GRADED A+.
The IRB will determine if a study is morally justified and demonstrates what key 4
items? - ...(ANSWERS)....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? - ...(ANSWERS)....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
Common Deficienceis of FDA inspections - ...(ANSWERS)....Failure to follow
protocol, Deviations, Inadequate record keeping, Inadequate accountability, ICF
issues/subject protections
OHRP - ...(ANSWERS)....Office For Human Research Protections.
1. Protects volunteers in research conducted supported by US Dept. of Health and
Human Services
2. Usually inspects IRBs
, 2
Definition of IRB approval - ...(ANSWERS)....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 - ...(ANSWERS)....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) - ...(ANSWERS)....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)
Discuss the basics of study design? - ...(ANSWERS)....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? - ...(ANSWERS)....Investigational Device Exemption. It permits a
device that otherwise would be required to comply with a performance standard
, 3
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? - ...(ANSWERS)....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 - ...(ANSWERS)....IDE must be submitted.
1.Implant or serious risk to health, safety, well-being
2.Supports/sustains human life
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 - ...(ANSWERS)....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.
, 4
How many days must the IRB revise its registration information? -
...(ANSWERS)....90 Days
What should sponsor obtain from investigator regarding IRB? - ...(ANSWERS)....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 - ...(ANSWERS)....Investigators: 2 years after marketing
applications approval or 2 years after investigation is discontinued and FDA is
notified.
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 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? -
...(ANSWERS)....2 years.
Can a clinical investigator submit an IDE? - ...(ANSWERS)....Yes. They can sponsor
their own study. They are considered a sponsor-investigator and must comply
with all responsibilities of both sponsor and investigator.
