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Package Deal For SOCRA Practice Test Questions with Verified Answers Top-Rated 2024
Package Deal For SOCRA Practice Test Questions with Verified Answers Top-Rated 2024
[Show more]Package Deal For SOCRA Practice Test Questions with Verified Answers Top-Rated 2024
[Show more]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 ...
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'...
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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'...
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...
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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...
SOCRA Certification Exam Questions 2024 With Updated Solutions
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Add to cartSOCRA Certification Exam Questions 2024 With Updated Solutions
21 CFR Part 11 
Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B 
Electronic Records 
21 CFR Part 11 Subpart C 
Electronic Signatures 
21 CFR Part 50 
Protection of Human Subjects 
21 CFR Part 50 Subpart B 
Informed Consent of Human Subjects 
21 CFR Part 50 Subpart D 
Additional S...
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Add to cart21 CFR Part 11 
Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B 
Electronic Records 
21 CFR Part 11 Subpart C 
Electronic Signatures 
21 CFR Part 50 
Protection of Human Subjects 
21 CFR Part 50 Subpart B 
Informed Consent of Human Subjects 
21 CFR Part 50 Subpart D 
Additional S...
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 
 
i...
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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 
 
i...
5 
The minimum number of IRB members 
Subjects cannot be enrolled until IRB/IEC approval has been obtained 
In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
The Sponsor 
The responsibility for ensuring th...
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The minimum number of IRB members 
Subjects cannot be enrolled until IRB/IEC approval has been obtained 
In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
The Sponsor 
The responsibility for ensuring th...
The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? 
 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
B) 5 
A significant risk device is defined ...
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Add to cartThe responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? 
 
A) FDA 
B) IRB 
C) Sponsor 
D) Coordinator 
C) Sponsor 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
B) 5 
A significant risk device is defined ...
How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days 
 
How many members must sit on an IRB? - 5 
 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research 
 
What are the criteria for IRB approval of research? (7) - 1. ...
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Add to cartHow many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days 
 
How many members must sit on an IRB? - 5 
 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research 
 
What are the criteria for IRB approval of research? (7) - 1. ...
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