What is 21 cfr 50 - Study guides, Class notes & Summaries
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SOCRA Practice Test Questions And Answers 2022
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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 Application (1571) 
 
 
 
In the top right corner, form have OMB number. Wh...
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SOCRA Practice Test 2022/2023 with Complete Solutions
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Which of the following is a disclosure of financial interests form? - ANSWER-FDA Form 3455 
 
Which of the following is a certification of financial interest form? - ANSWER-FDA Form 3454 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER-FDA Form 3455 
 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER-Investigational New Drug Application (1571) 
 
In the top right corner, form hav...
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SOCRA exam| 168 questions and answers already graded A+| Updated & Verified | 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) 
How man...
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CCRP Exam 2024 with 100%Correct Answers.
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CCRP Exam 2024 with 100%Correct Answers. 
How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answer5 
working days 
How many members must sit on an IRB? correct answer5 
How long must an IRB retain records per 21 CFR 56? correct answer3 years after completion of research 
What are the criteria for IRB approval of research? (7) correct answer1. Risks to subjects are minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subj...
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CCRP Exam Verified Questions And Answers Graded A 2024
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How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days 
 
How many members must sit on an IRB? - 5 
 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research 
 
What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 
2. Risks are reasonable in relation to anticipated benefits 
3. Selection of subjects is equitable 
4. Informed consent will be sought from subjects or LARs 
5. Infor...
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API 1169 Study Guide With Correct Answers.
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API 1169 Study Guide With Correct Answers. 
OSHA 1910 
______ document has the largest PPE section and safety definitions 
 
 
OSHA 1926 
_______ document has construction safety, safety focused on eye and face protection, excavation safety, scaffolds, cranes riggings, use of explosives' 
 
 
33 CFR 321 
______ document covers Dams/ Dikes, very infrequently used, very short and you will quickly be able to find what you need 
 
 
49 CFR 
____ document has hazardous materials tables, hazardous sh...
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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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SOCRA Practice Test Questions and Answers Already Passed
- Exam (elaborations) • 21 pages • 2024
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SOCRA Practice Test Questions and Answers Already Passed 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 Application (1571) 
In the top right cor...
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CCRP Definitions Questions And Answers.
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CCRP Definitions Questions And Answers. 
21 CFR 50 - correct answer Protection of Human Subjects 
 
Sponsor - correct answer a person who initiates a clinical investigation, but who does not actually conduct the investigation 
 
Sponsor-investigator - correct answer an individual who both initiates and actually conducts (alone or with others) a clinical investigation 
 
Human subject - correct answer an individual who is or becomes a participant in research, either as a recipient of the test art...
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SOCRA Exam Questions With 100% Correct Answers
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SOCRA Exam Questions With 100% Correct 
Answers 
When isn't an IND application needed? - answerIND Application is not needed if 
investigation does not support change in labeling. 
What information must the general IND include? 
(21 CFR Part 312.23) - 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 research/literature information 
-Addi...
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