45 cfr part 46 Study guides, Class notes & Summaries
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SOCRA CCRP Exam Questions and Answers 100% Solved
- Exam (elaborations) • 17 pages • 2024
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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 CCRP Exam Prep Questions with Approved Answers | Latest 2023/2024
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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 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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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 Test practice Questions and Answers 2024
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SOCRA Test practice Questions and Answers 2024 
The Purpose of the IRB is to: -Answer-Protect the rights and welfare of human subjects 
in research 
What is the minimum number of members required by an IRB -Answer-5 
Which of the following are necessary to waive consent? 
A.Subject is unable to give consent 
B.No time or unable to contact next of kin 
C.Life-Threatening Condition 
D.No other treatment available 
E.All of the above -Answer-all of the above 
This form is used for the mandatory rep...
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CCRP SOCRA Exam 2024 With Correct Solutions
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CCRP SOCRA Exam 2024 With Correct Solutions 
April 30 1996 - Answer -ICH GCP Development Date 
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 Con...
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SOCRA CCRP Exam Review questions and answers, VERIFIED// LATEST EXAM PREDICTIONS UPDATES, APPROVED.
- Exam (elaborations) • 24 pages • 2024
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SOCRA CCRP Exam Review questions 
and answers, VERIFIED/ 
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 - -...
-
SOCRA Test practice Questions and Answers 2024
- Exam (elaborations) • 22 pages • 2024
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- $13.49
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SOCRA Test practice Questions and Answers 2024 
The Purpose of the IRB is to: -Answer-Protect the rights and welfare of human subjects 
in research 
What is the minimum number of members required by an IRB -Answer-5 
Which of the following are necessary to waive consent? 
A.Subject is unable to give consent 
B.No time or unable to contact next of kin 
C.Life-Threatening Condition 
D.No other treatment available 
E.All of the above -Answer-all of the above 
This form is used for the mandatory rep...
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CCRP SOCRA FINAL EXAM STUDY GUIDE.
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CCRP SOCRA FINAL EXAM STUDY GUIDE. 
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 Investigations 
 
21 CF...
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SOCRA - CCRP (high level) Questions and Answers (100% Correct Solutions)
- Exam (elaborations) • 68 pages • 2023
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Nuremberg Code (1947) 
A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. 
 
 
The Nuremberg Code - 10 points 
1. voluntary 
2. necessary for results 
3. logical design and results 
4. avoid unnecessary harm 
5. cannot result in death or disablement 
6. risk assessment 
7. protect subjects against harm 
8. qualified investigators 
9. right to withdrawal 
10. right to end trial if needed 
 ...
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