.png){kind=logo}
SOCRA EXAM CERTIFICATION 2026-2027 ACTUAL EXAM 300 EXAM QUESTIOS AND CORRECT DETAILED ANSWERS (100% VERIFIED ANSWERS) |ALREADY GRADED A+
- SOCRA EXAM CERTIFICATION 2026-2027 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
.png)