Ccrp written exam Study guides, Class notes & Summaries
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SOCRA CCRP Exam Questions with all Correct Answers
- Exam (elaborations) • 17 pages • 2024
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SOCRA CCRP Exam Questions with all Correct Answers. 
>$25,000 - ANSWER-What is the $ reported amount for a financial disclosure for significant payments? 
 
.>$50,000 - ANSWER-What is the $ reported amount for a financial disclosure for equity interest in a publicly traded company? 
 
.1) A Short form Consent document 
2) An oral presentati...
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CCRP SOCRA CFR, ICH FDA Practice Exam Questions with Guaranteed Answers 2023/2024
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CCRP SOCRA CFR, ICH FDA Practice Exam Questions with Guaranteed Answers 2023/2024 
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 p...
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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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Certified Clinical Research Professional (CCRP) Exam Study Guide.
- Exam (elaborations) • 8 pages • 2024
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Certified Clinical Research Professional (CCRP) Exam Study Guide. 
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 res...
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Certified Clinical Research Professional (CCRP) Exam | 100% Correct Answers | Verified | Latest 2024 Version
- Exam (elaborations) • 8 pages • 2024
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Certified Clinical Research Professional 
(CCRP) Exam | 100% Correct Answers | 
 
Verified | Latest 2024 Version 
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 ...
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Certified Clinical Research Professional (CCRP) FDA- IND Application Exam practice Questions and Answers 2023/2024
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Certified Clinical Research Professional (CCRP) FDA- IND Application Exam practice Questions and Answers 2023/2024 
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 informati...
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Certified Clinical Research Professional (CCRP) /SOCRA Exam 2024
- Exam (elaborations) • 6 pages • 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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CCRP IDE, IRB and FDA Duration Requirement Exam Practice Guide Questions and Answers 2023/2024
- Exam (elaborations) • 8 pages • 2024
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CCRP IDE, IRB and FDA Duration Requirement Exam Practice Guide Questions and Answers 2023/2024 
Notice of change to the IDE - correct answer 5 Working Days Report to FDA 
 
Investigator to notify sponsor regarding IRB withdrawal of approval - correct answer 5 working days 
 
Investigator to report to sponsor and IRB use of a device without informed consent (emergency use) - correct answer 5 working days to Sponsor and IRB 
 
Sponsor to notify of IRB withdrawal of approval - correct answer 5 Work...
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Certified Clinical Research Professional (CCRP) Exam Already Passed
- Exam (elaborations) • 13 pages • 2023
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Certified Clinical Research Professional (CCRP) Exam Already Passed 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 in...
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Certified Clinical Research Professional (CCRP) Exam 100% Pass
- Exam (elaborations) • 13 pages • 2023
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Certified Clinical Research Professional (CCRP) Exam 100% Pass 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 informa...
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