SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE

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- </= 15 days

How long must an unanticipated adverse device effect (UADE) be

reported to the IRB? - ANSWER- </= 10 working days

How long must an unexpected fatal/life-threatening AE be reported to

the IRB? - ANSWER- <7>

How long do investigators need to keep current FDFs for? - ANSWERBefore study initiation, during the study, and 1 year after study

completion

What is a significant equity interest amount? - 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