50 cfr 21 Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about 50 cfr 21? On this page you'll find 547 study documents about 50 cfr 21.
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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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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 CCRP Exam Prep Questions with Approved Answers | Latest 2023/2024
- Exam (elaborations) • 20 pages • 2023
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SOCRA CCRP Exam Prep Questions with Approved Answers | Latest 2023/2024 
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 Standards ️ ICH 
E2A 
Safety pharmacology studies for human pharmaceuticals ️ ICH S7A 
Electronic records, electronic signatures ️ 21 CFR Part 11 
Informed Consent ️ 21 CFR Part 50 
...
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SOCRA CCRP Exam Questions and Answers 100% Solved
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Quality - ANSWER -ICH Q 
 
Efficacy - ANSWER -ICH E 
 
Safety - ANSWER -ICH S 
 
Multidisciplinary - ANSWER -ICH M 
 
guidance for industry, consolidated guideance - ANSWER -ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ANSWER -ICH E2A 
 
Safety pharmacology studies for human pharmaceuticals - ANSWER -ICH S7A 
 
Electronic records, electronic signatures - ANSWER -21 CFR Part 11 
 
Informed Consent - ANSWER -21 CFR Part 50 
 
Financial Disclosures - ANSWER -21 CFR Part 54...
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SOCRA Practice Test Questions and Answers Already Passed
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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 SoCRA Exam 2024 Study Guide
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21 CFR Part 11 
Electronic Records; Electronic Signatures 
21 CFR Part 11 Subpart B 
Electronic Records 
21 CFR Part 11 Subpart C 
Electronic Signatures 
21 CFR Part 50 
Protection of Human Subjects 
21 CFR Part 50 Subpart B 
Informed Consent of Human Subjects 
21 CFR Part 50 Subpart D 
Additional Safeguards for Children in Clinical Investigations 
21 CFR Part 56 
Institutional Review Board 
21 CFR Part 56 Subpart B 
Organization and Personnel 
21 CFR Part 56 Subpart C 
IRB Functions and Operati...
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CCRP Definitions Exam Questions With 100% Correct Answers.
- Exam (elaborations) • 27 pages • 2023
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21 CFR 50 - Protection of Human Subjects 
Sponsor - a person who initiates a clinical investigation, but who does not actually conduct the 
investigation 
Sponsor-investigator - an individual who both initiates and actually conducts (alone or with 
others) a clinical investigation 
Human subject - an individual who is or becomes a participant in research, either as a recipient of 
the test article or as a control 
Institution - any public or private entity or agency 
Institutional Review Board (...
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SOCRA Exam Questions With 100% Correct Answers
- Exam (elaborations) • 20 pages • 2024
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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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CCRP SOCRA Exam Graded A+
- Exam (elaborations) • 21 pages • 2024
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CCRP SOCRA Exam Graded A+ 
April 30 1996 - ANSICH GCP Development Date 
Quality - ANSICH Q 
Efficacy - ANSICH E 
Safety - ANSICH S 
Multidisciplinary - ANSICH M 
guidance for industry, consolidated guideance - ANSICH E 6 
Clinical Safety Data Management Definitions and Standards - ANSICH E2A 
Safety pharmacology studies for human pharmaceuticals - ANSICH S7A 
Electronic records, electronic signatures - ANS21 CFR Part 11 
Informed Consent - ANS21 CFR Part 50 
Financial Disclosures - ANS21 CFR Par...
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SOCRA CCRP Exam Questions with 100% Correct Answers
- Exam (elaborations) • 17 pages • 2024
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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 Standards ICH E2A 
 
Safety pharmacology studies for human pharmaceuticals ICH S7A 
 
Electronic records, electronic signatures 21 CFR Part 11 
 
Informed Consent 21 CFR Part 50 
 
Financial Disclosures 21 CFR Part 54 
 
Institutional Review Board 21 CFR Part 56 
 
IND Appli...
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