Timeline of Historical Events Correct Answer: Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979
The Three Principles of the Belmont Report Correct Answer: respect for persons, beneficence, justice
Application of Respect for Persons Correct Answer: informed consent (aut...
SOCRA CCRP Exam Flashcards| 62
QUESTIONS| 100% CORRECT ANSWERS
Timeline of Historical Events Correct Answer: Nuremberg Code 1947, Declaration of Helsinki
1964, Belmont Report 1979
The Three Principles of the Belmont Report Correct Answer: respect for persons, beneficence,
justice
Application of Respect for Persons Correct Answer: informed consent (autonomy, choose for
themselves)
Application of Beneficence Correct Answer: risk/benefit analysis
Application of Justice Correct Answer: appropriate selection of patients (equality)
Language Level ICF Correct Answer: 6th-8th grade
8 basic elements of ICF Correct Answer: 1. purpose, duration, and procedures
2. risks/discomforts
3. benefits
4. alternatives
5. confidentiality
6. compensation/medical treatments injury
7. contact information
8. voluntary participation and discontinuation at any time
Long ICF Correct Answer: standard consent form
Short ICF Correct Answer: a document that elements of ICF, orally stated, understood by
participant
4 components of consent process for short form Correct Answer: 1. short form document
2. oral presentation of ICF elements
3. IRB approved summary
4. a witness
When can you use short form? Correct Answer: language, short window
ICF monitoring Correct Answer: 1. most recent IRB approved version
2. signature present
3. subject dated/correct date
4. errors corrected by a single line
5. all pages present
, SAE Reporting Requirement Correct Answer: immediately investigator, 15 days for sponsor
UADE Reporting Requirement Correct Answer: 10 days investigator, 10 days for sponsor
Consent and Assent for children Correct Answer: Parental consent from 1 or both parents or
LAR required, and child assent may be required as determined by IRB
Time period where financial disclosure is needed Correct Answer: during the study and one year
after completion
The primary goal of the IRB Correct Answer: to protect the right and safety of human subjects
Composition of IRB Correct Answer: 5 or more members with different backgrounds including
1 scientific, 1 nonscientific, and 1 not affiliated
Definition of minimal risk and its expedited review process Correct Answer: no more harm than
routine exam; individual reviewer
Definition of significant risk and non-significant risk device Correct Answer: SR: the potential
for serious risk, support human life, substantial importance NSR: does not meet SR requirement
Difference between SR and NSR device studies Correct Answer: SR: Follows all IDE reg., IDE
app approved NSR: abbreviated requirements, no IDE app, and sponsor/IRB no report to FDA
prior
Time required for IRB record retension Correct Answer: 3 years after study completion
Two common tools used for reducing bias Correct Answer: Blinding and Randomization
Data Safety Monitoring Plan (DSMP) Correct Answer: is used to ensure safety of subjects and
validity of data
Data Safety Monitoring Board (DSMB) Correct Answer: a group of experts that reviews
research data
3 primary investigator responsibilties Correct Answer: 1. oversee the conduct of the trial
2. protect the rights, safety, and welfare of subjects
3. control the use of the investigational product
Significance of FDA 1572 and investigator agreement (device) Correct Answer: a declaration of
the investigator to comply with FDA regulations
Commitment of Investigator listed on 1572 Correct Answer: 1. follow the protocol
2. personally conduct or supervise the study
3. obtain informed consent
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