SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200
QUESTIONS AND CORRECT DETAILED ANSWERS WITH
RATIONALES |AGRADE
When is a short form ICF needed? – ANSWER- For subjects whose first
language is not English
What are the 10 points of the Nuremberg Code? – ANSWER- – Required
voluntary, informed consent
- Experiment aims at positive results for society
- Based on previous knowledge that justifies the experiment
- Study design avoids unnecessary physical and mental suffering and
injuries - Not conducted if there is any reason to believe it implies a risk of death
or disabling injury - Risks < Benefits
- Preparations and facilities must be provided to protect subjects against
risks - Staff must be fully trained and qualified
- Subject must be free to quit at any time
- Medical staff stop the experiment at any time if they observe
continuation would be dangerous.
When can an investigational product be used without a signed consent? –
ANSWER- – in a life threatening situation - inability to communicate
- time is not sufficient
- no alternate approved method available that provides an equal or
greater likelihood of saving the subject’s life
When can wards participate in a study? – ANSWER- – research related
to ward status - conducted in an environment with majority of children are not wards
- advocate has best interest of child during research
- advocate must not be associated with guardian organization, clinical
investigation, or the investigator
How long must a Suspected Unexpected Serious Adverse Reaction
(SUSAR) be reported to the IRB? – ANSWER- $50,000
What is considered a significant payment made from the sponsor to the
investigator? – ANSWER- > $25,000
What is the main purpose of the IRB? – ANSWER- Assure protection of
rights, safety, and welfare of human subjects.
Who provides the final approval of a study?
a. Sponsor
b. FDA
c. IRB – ANSWER- c. IRB
IRB must find when approving a study: – ANSWER- – risks are
minimized
- risks are reasonable for the anticipated benefits
- selection of subjects is equitable
- ICF follows guidelines
- ICF documented appropriately
- Adequate provisions for monitoring data collected to ensure the safety
of subjects - privacy and confidentiality is protected
- additional safeguards in place to protect vulnerable populations
- copies of research proposals reviewed
- minutes of IRB meetings
- records of continuing reviews
- copies of correspondence between IRB and investigator
- list of IRB members
- written procedures for the IRB
- statement of significant findings provided to subjects – ANSWERWhat is documented at IRB meetings?
What are significant risk devices? – ANSWER- – implants with potential
serious risks - used to support or sustain human life
- substantial importance in diagnosing, curing, or treating disease
What kind of investigational devices are exempt from Premarket
approval requirements? (IDE) – ANSWER- – diagnostic devices that are
non-invasive - for vet or lab use
- custom device not intended for commercial distribution
- distrubuted prior to May 1976
Who must be part of the IRB members? – ANSWER- – males and
females - varied background
- at least 5 members
- 1 scientific background