Socra exam Study guides, Class notes & Summaries
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SOCRA Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+
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SOCRA Exam (Latest 2024/ 2025 Update) Questions and Verified 
Answers| 100% Correct| Grade A+ 
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 ...
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SOCRA Exam Prep (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A+
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SOCRA Exam Prep (Latest 2024/ 2025 Update) Questions and 
Verified Answers| 100% Correct| Grade A+ 
The Purpose of the IRB is to: Protect the rights and welfare of human subjects in research 
What is the minimum number of members required by an IRB 5 
Which of the following are necessary to waive consent? 
A.Subject is unable to give consent 
B.No time or unable to contact next of kin 
C.Life-Threatening Condition 
D.No other treatment available 
E.All of the above all of the above 
This form is...
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SOCRA Exam Questions And Answers Latest Update
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SOCRA Exam Questions And Answers Latest Update
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SOCRA Exam Questions and Answers Top Graded 2024
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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. The criteria do not apply to paper records that are or have been transmitted by electronic means. 
 
If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consider the...
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CCRP SOCRA Exam - Practice Exam #1 Answered Questions
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CCRP SOCRA Exam - Practice Exam #1 Answered Questions
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CCRP SOCRA Exam - Practice Exam 1 Latest Update Already Passed
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CCRP SOCRA Exam - Practice Exam 1 Latest Update Already Passed 
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, safety, or welfare of a subje...
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SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
- Exam (elaborations) • 68 pages • 2024
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SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide 
 
 
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 - ANSWER Electronic Records 
 
 
 
Electronic records must use secure, computer generated, time-stamped audit trail...
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CCRP SOCRA Exam - Practice Exam 1 With Complete Solutions Latest Update
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CCRP SOCRA Exam - Practice Exam 1 With Complete Solutions Latest Update
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SOCRA Exam Questions and answers | Latest 2024/25 RATED A+
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SOCRA Exam Questions and answers | Latest 2024/25 RATED A+
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CCRP SOCRA Exam Graded A+
- Exam (elaborations) • 21 pages • 2024
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CCRP SOCRA Exam Graded A+ 
FDA Part 11 - ANSelectronic signatures are of the same validity as handwritten 
signatures, must provide 2 identifiers and verify identification of signer 
FDA Part 50 - ANSFood and Drugs, and ICF 
FDA Part 56 - ANSIRBs 
FDA Part 312 - ANSinvestigational new drug application 
FDA Part 812 - ANSinvestigational drug exemption 
FDA Form 482 - ANSNotice of inspection 
FDA Form 483 - ANSLetter of investigational observations/citation of 
noncompliance that specifies how lon...
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