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SOCRA CCRP Certification Exam With 100% Correct And Verified Answers
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SOCRA CCRP Certification Exam With 100% Correct And Verified Answers
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SOCRA CCRP Certification Exam With100% Correct And Verified Answers
Nuremburg Code - Correct Answer-The first set of
principles outlining professional ethics for clinical
research.
Nuremburg Code elements - Correct Answer-1.
Voluntary informed consent
2. research benefits society
3. should be based on prior animal work
4. avoid suffering and injury
5. research where death and disabling injury is
expected shouldn't be conducted
6. risks should be justified
7. proper preparations and adequate facilities
8. conducted by scientifically qualified
9. subjects can withdraw
10. research must end the study if there is probable
cause that continuing would lead to injury,
disability, or death.
Timeline of Historical Events - Correct Answer-
Nuremberg Code first (1947). Declaration of
Helsinki second (1964). Belmont Report third
(1979).
Belmont Report Principles and Application -
Correct Answer-There are 3:
1. Respect for persons = informed consent
2. Beneficence = risk/benefit analysis
3. Justice = appropriate selection of patients
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,Language Level Recommended for Informed
Consent - Correct Answer-6th-8th grade
8 Basic Elements of informed Consent - Correct
Answer-1. statement explaining the study involves
research.
2. description of risks or discomforts.
3. description of benefits.
4. alternative treatments/procedures.
5. confidentiality.
6. compensation for involvement and/or injury.
7. who to contact.
8. voluntary and can discontinue
Additional Elements of Informed Consent - Correct
Answer-1. unforeseeable risks to subject.
2. participation can be terminated by investigator.
3. any additional costs.
4. consequences of the subject's decision to
withdraw
5. significant new findings will be shared
6. approx # of subjects in the study.
Differences between short and long informed
consent form - Correct Answer-Long = the standard
consent form.
Short = document states that the elements have
been presented orally to and understood by the
subject or LAR.
ICF Monitoring Considerations - Correct Answer-1.
subject has signed most recent IRB approved
version
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, 2. subject signature is present in addition to
subject name
3. subject date themself and date is correct
4. any errors corrected w/single line thru error
5. all pages of ICF are present
SAE Reporting Requirements for Investigator and
Sponsor - Correct Answer-1. Investigator
immediately reports to Sponsor
2. Sponsor reports to FDA and all investigators
participating no later than 15 calendar days if it qualifies as
reportable.
What is a reportable SAE to the FDA? - Correct Answer-1. Serious and
unexpected
2. findings from other studies suggest significant risk
3. Findings from animal or in-vitro testing
4. increased rate of occurrence of SAEs
5. unanticipated adverse device effect (UADE)
What is a UADE? - Correct Answer-Unanticipated adverse device
effect (UADE) - any serious adverse effect on health or safety, any
life-threatening problem or death caused by, associated with the
device,.. not previously identified in nature, severity, or degree of
incidence in the applications; or any others if related to rights,
safety, or wefare of subjects
UADE Reporting Requirements for Investigator and Sponsors -
Correct Answer-1. Investigator submits to Sponsor and IRB asap,
but no later than 10 business days after knowledge of event
occurring.
2. Sponsor reports to all other IRBs and investigators, and FDA
within 10 working days
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