Socra exam Study guides, Class notes & Summaries
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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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SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
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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 Questions and Answers Graded A+ 	
- Exam (elaborations) • 22 pages • 2023
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CCRP SOCRA Exam Questions and Answers Graded A+
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SOCRA Actual/ Practice Test /CCRP SOCRA/SOCRA Certification Exam
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SoCRA (Actual Exam Graded A+)
SOCRA Practice Test Latest Updated Graded A+
CCRP SOCRA Exam Graded A+
SOCRA Certification Exam 2022/2023 with Complete Solution
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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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CCRP SOCRA Exam - Practice Exam 1 with Complete Solutions
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CCRP SOCRA Exam - Practice Exam 1 with Complete Solutions 
NB: Answers to questions appear at the bottom of the choices and are highlighted in yellow 
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...
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SOCRA Exam Study Guide 100%Verified Graded A 2024
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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 brochure 
-Protocol 
-Chemistry/Manufacturing information 
-Pharmacology/Toxicology 
-Previous human research/literature information 
-Additional information (drug dependence and abuse potential) 
 ...
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CCRP SOCRA EXAM - PRACTICE EXAM #1
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CCRP SOCRA EXAM - PRACTICE EXAM #1
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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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CCRP SOCRA Exam | 100% Correct Answers | Verified | Latest 2024 Version
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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 
subject 
B) Purported or represented to be for a use in ...
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