SOCRA CCRP Exam Flashcards| 62 QUESTIONS|
100% CORRECT ANSWERS
Timeline of Historical Events - ANSWER Nuremberg Code 1947, Declaration of
Helsinki 1964, Belmont Report 1979
The Three Principles of the Belmont Report - ANSWER respect for persons,
beneficence, justice
Application of Respect for Persons - ANSWER informed consent (autonomy,
choose for themselves)
Application of Beneficence - ANSWER risk/benefit analysis
Application of Justice - ANSWER appropriate selection of patients (equality)
Language Level ICF - ANSWER 6th-8th grade
8 basic elements of ICF - 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 - ANSWER standard consent form
Short ICF - ANSWER a document that elements of ICF, orally stated, understood
by participant
4 components of consent process for short form - ANSWER 1. short form
document
2. oral presentation of ICF elements
3. IRB approved summary
4. a witness
When can you use short form? - ANSWER language, short window
ICF monitoring - 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 - ANSWER immediately investigator, 15 days for
sponsor
UADE Reporting Requirement - ANSWER 10 days investigator, 10 days for
sponsor
Consent and Assent for children - 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 - ANSWER during the study and
one year after completion
The primary goal of the IRB - ANSWER to protect the right and safety of human
subjects
Composition of IRB - 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 - ANSWER no more
harm than routine exam; individual reviewer
Definition of significant risk and non-significant risk device - 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 - 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 - ANSWER 3 years after study completion
Two common tools used for reducing bias - ANSWER Blinding and Randomization
Data Safety Monitoring Plan (DSMP) - ANSWER is used to ensure safety of
subjects and validity of data
Data Safety Monitoring Board (DSMB) - ANSWER a group of experts that reviews
research data
3 primary investigator responsibilties - 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) - ANSWER a
declaration of the investigator to comply with FDA regulations
Commitment of Investigator listed on 1572 - ANSWER 1. follow the protocol
2. personally conduct or supervise the study
3. obtain informed consent
4. report AE
100% CORRECT ANSWERS
Timeline of Historical Events - ANSWER Nuremberg Code 1947, Declaration of
Helsinki 1964, Belmont Report 1979
The Three Principles of the Belmont Report - ANSWER respect for persons,
beneficence, justice
Application of Respect for Persons - ANSWER informed consent (autonomy,
choose for themselves)
Application of Beneficence - ANSWER risk/benefit analysis
Application of Justice - ANSWER appropriate selection of patients (equality)
Language Level ICF - ANSWER 6th-8th grade
8 basic elements of ICF - 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 - ANSWER standard consent form
Short ICF - ANSWER a document that elements of ICF, orally stated, understood
by participant
4 components of consent process for short form - ANSWER 1. short form
document
2. oral presentation of ICF elements
3. IRB approved summary
4. a witness
When can you use short form? - ANSWER language, short window
ICF monitoring - 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 - ANSWER immediately investigator, 15 days for
sponsor
UADE Reporting Requirement - ANSWER 10 days investigator, 10 days for
sponsor
Consent and Assent for children - 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 - ANSWER during the study and
one year after completion
The primary goal of the IRB - ANSWER to protect the right and safety of human
subjects
Composition of IRB - 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 - ANSWER no more
harm than routine exam; individual reviewer
Definition of significant risk and non-significant risk device - 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 - 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 - ANSWER 3 years after study completion
Two common tools used for reducing bias - ANSWER Blinding and Randomization
Data Safety Monitoring Plan (DSMP) - ANSWER is used to ensure safety of
subjects and validity of data
Data Safety Monitoring Board (DSMB) - ANSWER a group of experts that reviews
research data
3 primary investigator responsibilties - 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) - ANSWER a
declaration of the investigator to comply with FDA regulations
Commitment of Investigator listed on 1572 - ANSWER 1. follow the protocol
2. personally conduct or supervise the study
3. obtain informed consent
4. report AE
