SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL EXAM 300 EXAM QUESTIOS AND CORRECT DETAILED ANSWERS (100% VERIFIED ANSWERS) |ALREADY GRADED A+

SOCRA EXAM CERTIFICATION 2023-2024 ACTUAL

EXAM 300 EXAM QUESTIOS AND CORRECT

DETAILED ANSWERS (100% VERIFIED ANSWERS)

|ALREADY GRADED A+

What is the definition of a clinical investigation as it pertains to the

FDA's informed consent regulations? - ANSWER- Clinical investigation

means any experiment that involves a test article and one or more human

subjects that is either subject to FDA requirements, or not subject to

FDA requirements, but is intended to be submitted to, or held for

inspection by the FDA, as part of a marketing application.

A sponsor-investigator may be a corporation, such as a pharmaceutical

company. T or F? - ANSWER- False.

A sponsor-investigator must be an individual.

What stipulation is mandated for the length of time a prospective

research subject is given to determine whether or not to participate in a

research trial? - ANSWER- Sufficient opportunity to consider whether

or not to participate must be allowed, under circumstances which

minimize the possibility of coercion or undue influence.

Under what conditions may an investigator enter a human subject into a

research study employing the exception from general informed consent

requirements? - ANSWER- a. Prior to enrolling a subject, both the

investigator and an independent physician certify in writing:

i. The subject is in a life-threatening situation which necessitates use of

the test article, is unable to give legally informed consent,

ii. Time is insufficient to obtain consent from the subject's legal

representative,

iii. And there are no alternative methods or therapies available that

provide an equal or greater chance of saving the subject's life.

An informed consent document may not include any exculpatory

language through which the subject or subject's representative releases

or appears to release which parties from liability or negligence? -

ANSWER- The investigator, the sponsor, the institution or its agents.

If an investigator employs the exception from general requirements

process for obtaining consent, within how many days must a full report

of the circumstances be reported to the IRB? - ANSWER- Within five

working days after use of the test article

Following enrollment of a subject into a study under the exception from

general requirements criteria for obtaining consent, a written review by a

physician not associated with the investigation must be submitted to the

IRB within 10 working days. T or F? - ANSWER- False.

Within 5 working days after use of the test article.

Subject to extensive requirements including documentation and ethical

reviews, the U. S. President may approve the use of investigational

drugs for military personnel without first obtaining informed consent

when the DoD is the sponsor of an IND. T or F? - ANSWER- True

With emergency research involving waiver of consent, public disclosure

of the research before and after the research within the local community

is required. T or F? - ANSWER- True.

IRBS must ensure special criteria are met prior to approving emergency

research that will allow subject entry without first obtaining informed

consent. T or F? - ANSWER- True

Under certain limitations, research may be done for emergency

conditions under an informed consent waiver, if approved by an IRB. T

or F? - ANSWER- True

The FDA provides no regulatory basis to conduct research if written

informed consent cannot be obtained from subjects prior to entry into a

study. T or F? - ANSWER- False.

Research may be conducted with waived consent for emergency

conditions, or under the general exception from informed consent

criteria.

If clini vestigations could not normally be completed in patients with

emergency conditions, due to inability to obtain informed consent,

special criteria exist to enable such research to be done. T or F? -

ANSWER- True

What must investigators commit to when conducting research under

emergency conditions, relative to obtaining informed consent for

subjects who are unable to give consent? - ANSWER- Attempting to

contact a family member or legally authorized representative within a

protocol-specified therapeutic window to determine if they object to the

subject's participation in the research.

Prior to approving emergency research, an IRB must assure that

additional protections are in place regarding the rights and welfare of

prospective subjects. Name at least two of these additional protections. -

ANSWER- a. Consultation with community representatives

b. Public disclosure to the community regarding risks, prior to the study.

c. Public disclosure of the results

d. Establishment of an independent data monitoring committee

e. Attempting to contact a family member, if feasible, to ask whether he

or she objects

What role do family members have regarding consent for participation

in emergency research studies? - ANSWER- Family members are to be

consulted with by investigators to determine if the object to subject's

participation, or continuation in a research study, and are to be fully

informed of the investigation, if feasible, even if the subject dies.

If a subject enrolled in an emergency research study without informed

consent remains incapacitated, how soon must a legally authorized

representative or family member be made aware of the content of the

informed consent document? - ANSWER- At the earliest feasible

opportunity

If a subject entered into a research study under waived consent criteria

dies before legally authorized representatives or family members can be

contacted, these affiliates must be informed about the investigation. T or

F? - ANSWER- True

If an IRB makes a decision not to approve research under waived

consent criteria due to perceived non-complianc regulatio or ethical

concerns, whom must the IRB notify? - ANSWER- The clinical

investigator and the sponsor.

Subjects enrolled in emergency research with waived consent, must be

informed about the study if their condition improves, even if a legally

authorized representative or family eno member consented on their

behalf, or did not object to their participation. T or F? - ANSWER- True

If a sponsor is notified by an IRB that a research investigation intended

to be conducted under the waived consent emergency research

regulations cannot be approved, whom must the sponsor notify of this

decision? - ANSWER- a. The FDA

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