312 50 exam questions Study guides, Class notes & Summaries
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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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SOCRA CCRP 2023 Exam Questions and Answers All Correct
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SOCRA CCRP 2023 Exam Questions and Answers All Correct 
FDA Part 11 - Answer-electronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer 
 
FDA Part 50 - Answer-Food and Drugs, and ICF 
 
FDA Part 56 - Answer-IRBs 
 
FDA Part 312 - Answer-investigational new drug application 
 
FDA Part 812 - Answer-investigational drug exemption 
 
FDA Form 482 - Answer-Notice of inspection 
 
FDA Form 483 - Answer-Letter of investiga...
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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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COM-312 Final Exam 50 Questions with Verified Answers,100% CORRECT
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COM-312 Final Exam 50 Questions with Verified Answers 
 
Which form of alternative dispute resolution gives parties the most control in determining their own solutions to their conflict? - CORRECT ANSWER Facilitation 
 
A person who is caught up in what has happened to her or him and uses the story to get sympathy from others may be caught up in the "eddy" of: - CORRECT ANSWER Victimization 
 
Individuals are more likely to renegotiate a relationship through forgiveness when they know which of...
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CCRP SoCRA 21 CFR PARTS Exam Questions and certified Answers 2023/2024
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CCRP SoCRA 21 CFR PARTS Exam Questions and certified Answers 2023/2024 
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...
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Final Exam: NRNP 6566/ NRNP6566 Advanced Care of Adults in Acute Settings I| Questions and Verified Answers| TOP PRIORITY EXAM 2023/ 2024 New Update- Walden UNIVERSITY
- Exam (elaborations) • 24 pages • 2023
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Final Exam: NRNP 6566/ NRNP6566 Advanced Care of Adults in Acute Settings I| Questions and Verified Answers| TOP PRIORITY EXAM 2023/ 2024 New Update- Walden UNIVERSITY 
 
Question 1 
Which antibiotics would NOT be appropriate to empirically treat an E. Coli infection? 
Penicillin VK (Pen VK) Cephalexin (Keflex) Nitrofurantoin (Macrobid) 
Trimethoprim-Sulfamethoxazole (Bactri m DS) 
 
 
Question 2 
The NP is managing a 66 year old female admitted to the ICU with a serum potassium level of 
...
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CCRP SoCRA Exam Cert Exam Questions with Verified Answers 2024
- Exam (elaborations) • 7 pages • 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 CCRP Sponsor, Investigational Drug and Device Exam Review Questions and Answers 2023/2024
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SOCRA CCRP Sponsor, Investigational Drug and Device Exam Review Questions and Answers 2023/2024 
April 30 1996 - correct answer ICH GCP Development Date 
 
Quality - correct answer ICH Q 
 
Efficacy - correct answer ICH E 
 
Safety - correct answer ICH S 
 
Multidisciplinary - correct answer ICH M 
 
guidance for industry, consolidated guideance - correct answer ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A 
 
Safety pharmacology studies for human ...
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CCRA EXAM LATEST QUESTIONS AND ANSWERS
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CCRA EXAM LATEST QUESTIONS AND ANSWERS 
 
What is 21 CFR 812? 
IDE 
What is 21 CFR 600? 
Biological Products 
What is 21 CFR 11? 
Electronic Records 
What is 21 CFR 50? 
Informed Consent 
What is ICH E6: 8 
Essential Documents 
What is the purpose of maintaining study document and records? 
Insure compliance; dealing with safety of patient, things have to be written down 
What are source document? 
First place data is written 
What are case report forms? 
Provides format for collecting protocol-...
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Fire Inspector Practice Exam Questions and Answers Already Graded A
- Exam (elaborations) • 11 pages • 2023
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Fire Inspector Practice Exam Questions and Answers Already Graded A 
Which of the following is NOT considered to be a model code orgnization? 
A. National Fire Protection Association 
B. National Fire Academy 
C. International Code Counil D. American Society of Mechanical Engineers B. National Fire Academy 
A prescriptive code does which of the following? 
A. List the specific details the installation or construction must meet 
B. Requires equipment to be installed for protection against a hazar...
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