SoCRA CERTIFICATION EXAM WITH
VERIFIED QUESTIONS AND ANSWERS||
ALREADY GRADED A+ || GURANTEED PASS||
LATEST VERSION 2025
What 5 classes of products do the informed consent regulations apply? (test
articles) - ANSWER-- drugs
- medical devices
- biological products
- electronic products
- food (including dietary supplements and infant formulas)
- color additives
Waiver of Signed Informed Consent - ANSWER-- if the only record linking the
subject to the research would be the consent document and the principal risk
would result from breach in confidentiality
- the research presents no more than minimal risk of harm to subjects and
involves no procedures for which written consent is normally required outside
the context of research
Types of federally-funded research that may be done using prisoners as subjects
- ANSWER-- possible causes, effects, and processes of incarceration and
criminal behavior
- prisons as institutional structures or prisoners as incarcerated persons
- conditions particularly affecting prisoners
- practices aimed at improving the health or well-being of prisoners
,3 regulatory agency sponsors of ICH - ANSWER-European Union, Japan,
United States
What ethical standards are the ICH document based on? - ANSWER-
Declaration of Helsinki
What special population must the IRB pay special attention to? - ANSWER-
Vulnerable subjects
Minimum risk - ANSWER-the probability and magnitude of anticipated harm
or discomfort are not greater, in and of themselves, than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
Department of Agency Head - ANSWER-The head of any federal department
or agency and any other officer or employee of any department or agency to
whom authority has been delegated. (45 CFR, sec. 46.102)
Legally Authorized Representative (LAR) - ANSWER-An individual or judicial
or other body authorized under applicable law to consent on behalf of a
prospective subject to the subject's participation in the procedures involved in
the research. (45 CFR, sec. 46.102)
Viable - ANSWER-As it pertains to the neonate, means being able after
delivery to survive.
Human Subject - ANSWER-A living individual about whom an investigator
conducting research obtains 1)Data through intervention or interaction with the
individual 2) Identifiable private information. (45 CFR, sec. 46.102)
, Certification - ANSWER-The official notification by the institution to the
supporting department or agency, in accordance with the requirements of this
policy, that a research project or activity involving human subjects has been
reviewed and approved by an IRB in accordance with an approved assurance.
(45 CFR, sec. 46.102)
Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended
responses to a medicinal product related to any dose. (ICH GCP E6 1.1)
Adverse Event (AE) - ANSWER-Any untoward medical occurrence in a patient
or clinical investigation subject administered a pharmaceutical product and
which does not necessarily have a causal relationship with this treatment. (ICH
GCP E6 1.2)
Informed Consent ADDITIONAL Elements: - ANSWER-- risk to embyro or
fetus
- termination procedures
- costs to study subjects
- approximate number of study subjects
- a statement of new findings when they may impact a subject's willingness to
participate
Oral consent - ANSWER-- requires a witness
- subject must sign short form only
- witness must sign both short form and summary of what was said
Form 3500 - ANSWER-Voluntary safety reporting of adverse events and
product problems
VERIFIED QUESTIONS AND ANSWERS||
ALREADY GRADED A+ || GURANTEED PASS||
LATEST VERSION 2025
What 5 classes of products do the informed consent regulations apply? (test
articles) - ANSWER-- drugs
- medical devices
- biological products
- electronic products
- food (including dietary supplements and infant formulas)
- color additives
Waiver of Signed Informed Consent - ANSWER-- if the only record linking the
subject to the research would be the consent document and the principal risk
would result from breach in confidentiality
- the research presents no more than minimal risk of harm to subjects and
involves no procedures for which written consent is normally required outside
the context of research
Types of federally-funded research that may be done using prisoners as subjects
- ANSWER-- possible causes, effects, and processes of incarceration and
criminal behavior
- prisons as institutional structures or prisoners as incarcerated persons
- conditions particularly affecting prisoners
- practices aimed at improving the health or well-being of prisoners
,3 regulatory agency sponsors of ICH - ANSWER-European Union, Japan,
United States
What ethical standards are the ICH document based on? - ANSWER-
Declaration of Helsinki
What special population must the IRB pay special attention to? - ANSWER-
Vulnerable subjects
Minimum risk - ANSWER-the probability and magnitude of anticipated harm
or discomfort are not greater, in and of themselves, than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
Department of Agency Head - ANSWER-The head of any federal department
or agency and any other officer or employee of any department or agency to
whom authority has been delegated. (45 CFR, sec. 46.102)
Legally Authorized Representative (LAR) - ANSWER-An individual or judicial
or other body authorized under applicable law to consent on behalf of a
prospective subject to the subject's participation in the procedures involved in
the research. (45 CFR, sec. 46.102)
Viable - ANSWER-As it pertains to the neonate, means being able after
delivery to survive.
Human Subject - ANSWER-A living individual about whom an investigator
conducting research obtains 1)Data through intervention or interaction with the
individual 2) Identifiable private information. (45 CFR, sec. 46.102)
, Certification - ANSWER-The official notification by the institution to the
supporting department or agency, in accordance with the requirements of this
policy, that a research project or activity involving human subjects has been
reviewed and approved by an IRB in accordance with an approved assurance.
(45 CFR, sec. 46.102)
Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended
responses to a medicinal product related to any dose. (ICH GCP E6 1.1)
Adverse Event (AE) - ANSWER-Any untoward medical occurrence in a patient
or clinical investigation subject administered a pharmaceutical product and
which does not necessarily have a causal relationship with this treatment. (ICH
GCP E6 1.2)
Informed Consent ADDITIONAL Elements: - ANSWER-- risk to embyro or
fetus
- termination procedures
- costs to study subjects
- approximate number of study subjects
- a statement of new findings when they may impact a subject's willingness to
participate
Oral consent - ANSWER-- requires a witness
- subject must sign short form only
- witness must sign both short form and summary of what was said
Form 3500 - ANSWER-Voluntary safety reporting of adverse events and
product problems
