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[Show more]SOCRA Practice Test Question and 
Answer 100% Correct 
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...
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Add to cartSOCRA Practice Test Question and 
Answer 100% Correct 
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...
SOCRA Question and Answer 100% 
Correct | Graded A+ 
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 
-Tabl...
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Add to cartSOCRA Question and Answer 100% 
Correct | Graded A+ 
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 
-Tabl...
SOCRA Questions and Answers 100% 
Correct 
Respect for persons, justice, beneficence - List the three ethical 
principles of the Belmont report 
Experiment that involves a test article and one or more human subjects - 
does not include experiments which are nonclinical lab studies - Define 
clinical...
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Add to cartSOCRA Questions and Answers 100% 
Correct 
Respect for persons, justice, beneficence - List the three ethical 
principles of the Belmont report 
Experiment that involves a test article and one or more human subjects - 
does not include experiments which are nonclinical lab studies - Define 
clinical...
SOCRA CCRP Exam Questions and 
Answers 100% Solved | Latest Update 
April 30 1996 - ICH GCP Development Date 
Quality - ICH Q 
Efficacy - ICH E 
Safety - ICH S 
Multidisciplinary - ICH M 
guidance for industry, consolidated guideance - ICH E 6 
Clinical Safety Data Management Definitions and Standar...
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Add to cartSOCRA CCRP Exam Questions and 
Answers 100% Solved | Latest Update 
April 30 1996 - ICH GCP Development Date 
Quality - ICH Q 
Efficacy - ICH E 
Safety - ICH S 
Multidisciplinary - ICH M 
guidance for industry, consolidated guideance - ICH E 6 
Clinical Safety Data Management Definitions and Standar...
Socra Exam Prep Exam Questions and 
Answers 100% Solved | Rated A+ 
Laws - passed by national legislative bodies; establish authority of 
national regulatory body 
Regulations - Passed by regulatory authorities; controls how medical 
products are investigated and approved; have effect of law 
guidan...
Preview 4 out of 33 pages
Add to cartSocra Exam Prep Exam Questions and 
Answers 100% Solved | Rated A+ 
Laws - passed by national legislative bodies; establish authority of 
national regulatory body 
Regulations - Passed by regulatory authorities; controls how medical 
products are investigated and approved; have effect of law 
guidan...
SOCRA Exam Questions and Answers 
100% Solved | Graded A+ 
Electronic signature are currently accepted for any and all records, paper or 
electronic form. True or False? - False. The general provisions for 
electeonic signature criteria apply to records that are 
i. Created, modified, maintained, ar...
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Add to cartSOCRA Exam Questions and Answers 
100% Solved | Graded A+ 
Electronic signature are currently accepted for any and all records, paper or 
electronic form. True or False? - False. The general provisions for 
electeonic signature criteria apply to records that are 
i. Created, modified, maintained, ar...
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