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SOCRA Bundled Exams Questions and Answers Latest Update (2023/2024) (Complete and Accurate)
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SOCRA Bundled Exams Questions and Answers Latest Update (2023/2024) (Complete and Accurate)
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SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
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SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide 
 
Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? 
 
Answer: 
1) Progress of investigations under IND 
2) Secure compliance or discontinue investigators that are not compliant and notify FDA 
3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 
4) Notify FDA, all IRBs and all investigators if drug presen...
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Certified Clinical Research Professional (CCRP) /SOCRA Exam 2024
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Certified Clinical Research Professional 
(CCRP) /SOCRA Exam 2024 
When isn't an IND application needed? - CORRECT ANSWER-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) - CORRECT 
ANSWER-FDA Form 1571: 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investigative plan 
-Investigator's brochure 
-Protocol 
-Chemistry/Manufacturing information 
-Pharmacology/toxicology 
-Previous human ...
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Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A
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Test for SOCRA CCRP EXAM (Mega 
certification 2024) Q&A 
5 - CORRECT ANSWER-The minimum number of IRB members 
Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT 
ANSWER-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 - CORRECT ANSWER-The responsibility for ensuring that the investigator 
understands a clinical trial lies with: 
A subject has been enrolled...
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SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest
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SOCRA CCRP Prep Exam Study 
Questions and Answers 2024 latest 
Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, 
Declaration of Helsinki 1964, Belmont Report 1979 
The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, 
beneficence, justice 
Application of Respect for Persons - CORRECT ANSWER-informed consent 
(autonomy, choose for themselves) 
Application of Beneficence - CORRECT ANSWER-risk/benefit analysis 
Application of Justice - CORRECT ANSW...
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CCRP SOCRA Practice Exam 2024 Final questions and correct answers
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CCRP SOCRA Practice Exam 2024 Final 
questions and correct answers 
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 - CORRECT ANSWER-C) Sponsor 
What is the minimum number of IRB Members? 
A) 3 
B) 5 
C) 6 
D) 10 - CORRECT ANSWER-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...
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SOCRA Actual Certification Exam 2024 questions and answers A-graded
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SOCRA Actual Certification Exam 2024 
questions and answers A-graded 
Electronic Records - CORRECT ANSWER-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 - CORRECT ANSWER-Electronic records must use 
secure, computer generated, time-stamped audit trails to independently record the date...
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SOCRA (CCRP) Exam Practice Questions and Answers 2024
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SOCRA (CCRP) Exam Practice 
Questions and Answers 2024 
The Belmont Report's principle of respect for persons incorporates at least two ethical 
convictions: first, that individuals should be treated as autonomous agents, and second, 
that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to 
protection.
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SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers
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SOCRA Practice Test Certification Final 
Exam Questions with 100% Correct 
answers 
Which of the following is a disclosure of financial interests form? - CORRECT 
ANSWER-FDA Form 3455 
Which of the following is a certification of financial interest form? - CORRECT 
ANSWER-FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit 
the following form: - CORRECT ANSWER-FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginnin...
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SOCRA Certification Exam Guide 2024 with correct answer
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SOCRA Certification Exam Guide 2024 
with correct answer 
Does the FDA consider electronic signatures to be as trustworthy and reliable as 
handwritten paper signatures? - CORRECT 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 ? - CORRECT ANSWER-Yes 
Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by 
people who are responsible...
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CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024
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CCRP SoCRA Exam Cert Exam 
Questions with Verified Answers 2024 
21 CFR Part 11 - CORRECT ANSWER-Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B - CORRECT ANSWER-Electronic Records 
21 CFR Part 11 Subpart C - CORRECT ANSWER-Electronic Signatures 
21 CFR Part 50 - CORRECT ANSWER-Protection of Human Subjects 
21 CFR Part 50 Subpart B - CORRECT ANSWER-Informed Consent of Human 
Subjects 
21 CFR Part 50 Subpart D - CORRECT ANSWER-Additional Safeguards for Children in 
Clinical ...
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SOCRA Certification Exam Questions and Answers 2024 100% Correct
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SOCRA Certification Exam Questions 
and Answers 2024 100% Correct 
Biometrics - CORRECT ANSWER-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 - CORRECT ANSWER-An environment in which system access is 
controlled by persons who are responsible for the content of electronic records that a...
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