Socra Study guides, Class notes & Summaries
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SOCRA Certification Exam Q&A 2022/2023
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Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - Answer - Yes (although permission to use such e-sigs has to be approved by the FDA) 
 
Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - Answer - Yes 
 
Open system (FDA term) - Answer - System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data i...
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SOCRA Practice Test 2022/2023 with Complete Solutions
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Which of the following is a disclosure of financial interests form? - ANSWER-FDA Form 3455 
 
Which of the following is a certification of financial interest form? - ANSWER-FDA Form 3454 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER-FDA Form 3455 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER-Investigational New Drug Application (1571) 
 
In the top right corner, form hav...
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023
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CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 
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 as an investigational device that is: 
 
A) Intended as an implant and presents a potential for serious risk to the health, s...
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GTP SOCRATIVE QUIZZES (INCL. EXAM SOLUTIONS 2022-2023)
- Other • 25 pages • 2023
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Dit document bevat alle Socrative Quizzes vragen met antwoorden en uitleg. Ook is het EXAM en RE-EXAM 2022-2023 bijgevoegd met alle antwoorden.
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SoCRA Certification Exam 2023 with complete answers
- Exam (elaborations) • 12 pages • 2023
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SoCRA Certification Exam 2023 with complete answers 
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 access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) 
 
 
 
Digi...
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SoCRA Certification Examination Bundle (2023 - 2024)
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SoCRA Certification Examination Bundle (2023 - 2024)
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SoCRA Certification Exam 2024
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SoCRA Certification Exam 2024 
 
 
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) - ANSWER Biometrics 
 
 
 
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) - ...
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SOCRA Practice Test Questions And Answers 2022
- Exam (elaborations) • 10 pages • 2022
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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 
 
 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial 
Investigational New Drug Application (1571) 
 
 
 
In the top right corner, form have OMB number. Wh...
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SOCRA Practice Test 2024/25
- Exam (elaborations) • 21 pages • 2024
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SOCRA Practice Test 2024/25 
Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 
 
 
 
Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 
 
 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER FDA Form 3455 
 
 
 
This form is s...
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SOCRA Certification Exam 100% CORRECT ANSWERS 2023 NEW FILE
- Exam (elaborations) • 26 pages • 2023
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QUESTIONS AND ANSWERS