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[Show more]When isn't an IND application needed? IND Application is not needed if investigation does not 
support change in labeling. 
What information must the general IND include? 
(21 CFR Part 312.23) -FDA Form 1571 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investigative Plan 
-Investigator's broc...
Preview 4 out of 31 pages
Add to cartWhen isn't an IND application needed? IND Application is not needed if investigation does not 
support change in labeling. 
What information must the general IND include? 
(21 CFR Part 312.23) -FDA Form 1571 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investigative Plan 
-Investigator's broc...
Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 
1979 
The Three Principles of the Belmont Report - respect for persons, beneficence, justice 
Application of Respect for Persons - informed consent (autonomy, choose for themselves) 
Application of Ben...
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Add to cartTimeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 
1979 
The Three Principles of the Belmont Report - respect for persons, beneficence, justice 
Application of Respect for Persons - informed consent (autonomy, choose for themselves) 
Application of Ben...
Electronic signature are currently accepted for any and all records, paper or electronic form. True or 
False? - False. The general provisions for electeonic signature criteria apply to records that are 
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form 
ii. T...
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Add to cartElectronic signature are currently accepted for any and all records, paper or electronic form. True or 
False? - False. The general provisions for electeonic signature criteria apply to records that are 
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form 
ii. T...
Which of the following is a disclosure of financial interests form? - FDA Form 3455 
Which of the following is a certification of financial interest form? - FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following 
form: - FDA Form 3455 
T...
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Add to cartWhich of the following is a disclosure of financial interests form? - FDA Form 3455 
Which of the following is a certification of financial interest form? - FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following 
form: - FDA Form 3455 
T...
If immediate use of the test article (exception) is used to preserve the life of a subject and time is not 
sufficient to obtain IC, within X an independent physician should review the use of the article - 5 
days 
If an article is used in an exempt way, this should be reported to the IRB in X after...
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Add to cartIf immediate use of the test article (exception) is used to preserve the life of a subject and time is not 
sufficient to obtain IC, within X an independent physician should review the use of the article - 5 
days 
If an article is used in an exempt way, this should be reported to the IRB in X after...
Biometrics - A method of verifying an individual's identity based on measurement of the individual's 
physical features or repeatable actions where those features and or actions are both unique to that 
individual and measurable. (21 CFR, Sec. 11.3) 
Closed System - An environment in which system ...
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Add to cartBiometrics - A method of verifying an individual's identity based on measurement of the individual's 
physical features or repeatable actions where those features and or actions are both unique to that 
individual and measurable. (21 CFR, Sec. 11.3) 
Closed System - An environment in which system ...
Electronic Records - Use of electronic records must have procedures to ensure the authenticity, 
integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily 
repudiate the signed records a snot genuine 
Electronic Records - Audit Trail - Electronic records mu...
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Add to cartElectronic Records - Use of electronic records must have procedures to ensure the authenticity, 
integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily 
repudiate the signed records a snot genuine 
Electronic Records - Audit Trail - Electronic records mu...
Which of the following is a disclosure of financial interests form? - 
Which of the following is a certification of financial interest form? - 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following 
form: - 
This form is submitted by sponsor to the...
Preview 2 out of 13 pages
Add to cartWhich of the following is a disclosure of financial interests form? - 
Which of the following is a certification of financial interest form? - 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following 
form: - 
This form is submitted by sponsor to the...
IRB approval - the determination of the IRB that the clinical investigation has been reviewed and 
may be conducted at an institution within the constraints set forth by the IRB and other institutional and 
federal requirements. 
Contract Research Organization (CRO) - a person that assumes, as an in...
Preview 4 out of 31 pages
Add to cartIRB approval - the determination of the IRB that the clinical investigation has been reviewed and 
may be conducted at an institution within the constraints set forth by the IRB and other institutional and 
federal requirements. 
Contract Research Organization (CRO) - a person that assumes, as an in...
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