45 cfr part 46 Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about 45 cfr part 46? On this page you'll find 205 study documents about 45 cfr part 46.
All 205 results
Sort by
-
CCRP SoCRA Exam Latest Update Rated A
- Exam (elaborations) • 12 pages • 2024
- Available in package deal
-
- $9.99
- 1x sold
- + learn more
CCRP SoCRA Exam Latest Update Rated A 
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 Subpa...
-
UST Test Questions And Answers Latest Updated 2024/2025 (Graded A+)
- Exam (elaborations) • 46 pages • 2024 Popular
- Available in package deal
-
- $18.49
- 1x sold
- + learn more
UST Test Questions And Answers Latest Updated 2024/2025 (Graded A+) The regulations to enforce compliance of underground storage tank systems in the state 
are found in? 
a.) Code of Federal Regulations, 40 CFR Part 281 
b.) California Code of Regulations, Title 23, Chapter 16 
c.) Code of Federal Regulations, 40 CFR Part 280 
d.) California Code of Regulations, Title 23, Chapter 17 - Correct answer b.) 
California Code of Regulations; Title 23, Chapter 16 
2) By definition an "underground stora...
-
CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As
- Exam (elaborations) • 10 pages • 2024
-
- $13.99
- + learn more
CCRP SOCRA Exam - Practice Exam #1 (Practice Test #1 (Ethics, 21 CFR Parts 50, 56, 312, 812; 45 CFR Part 46) Past questions directly from SOCRA) Passed Qs & As
-
CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023
- Exam (elaborations) • 11 pages • 2023
-
Available in package deal
-
- $17.99
- 1x sold
- + learn more
CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 
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 
C) Sponsor 
 
 
 
What is the minimum number of IRB Members? 
 
A) 3 
B) 5 
C) 6 
D) 10 
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 risk to the health, s...
-
Certification for IRB Professionals (CIP) Exam Complete Q&A 2024.
- Exam (elaborations) • 5 pages • 2023
-
- $34.49
- 1x sold
- + learn more
Certification for IRB Professionals (CIP) Exam Complete Q&A 2023. 
 
According to the Belmont Report, respect for persons usually demands that subjects... 
 
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - 
A poorly designed protocol is considered unethical because... - 
 
When should an IRB suspend or terminate approval of research? - 
 
A quorum for a convened IRB meeting requires the pr...
Fear of missing out? Then don’t!
-
SoCRA Certification Exam 2023 with complete answers
- Exam (elaborations) • 12 pages • 2023
-
Available in package deal
-
- $17.99
- 1x sold
- + learn more
SoCRA Certification Exam 2023 with complete answers 
Biometrics 
A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
 
 
Closed System 
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) 
 
 
 
Digi...
-
SOCRA CCRP Exam Questions And Answers
- Exam (elaborations) • 33 pages • 2024
-
- $10.99
- + learn more
SOCRA CCRP Exam Questions And Answers 
 
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 ...
-
SOCRA CCRP Exam Questions With 100% Correct Answers.
- Exam (elaborations) • 24 pages • 2024
-
Available in package deal
-
- $11.49
- + learn more
SOCRA CCRP Exam Questions With 100% Correct Answers. 
April 30 1996 - correct answer ICH GCP Development Date 
 
Quality - correct answer ICH Q 
 
Efficacy - correct answer ICH E 
 
Safety - correct answer ICH S 
 
Multidisciplinary - correct answer ICH M 
 
guidance for industry, consolidated guideance - correct answer ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A 
 
Safety pharmacology studies for human pharmaceuticals - correct answer ICH S7A 
 ...
-
CCRP SOCRA Exam Graded A+
- Exam (elaborations) • 21 pages • 2024
- Available in package deal
-
- $11.49
- + learn more
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...
-
SOCRA CCRP Exam 2024 with Complete Solutions!
- Exam (elaborations) • 17 pages • 2024
-
- $14.49
- + learn more
April 30 1996 - ANSWERSICH GCP Development Date 
 
Quality - ANSWERSICH Q 
 
Efficacy - ANSWERSICH E 
 
Safety - ANSWERSICH S 
 
Multidisciplinary - ANSWERSICH M 
 
guidance for industry, consolidated guideance - ANSWERSICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ANSWERSICH E2A 
 
Safety pharmacology studies for human pharmaceuticals - ANSWERSICH S7A 
 
Electronic records, electronic signatures - ANSWERS21 CFR Part 11 
 
Informed Consent - ANSWERS21 CFR Part 50 
 
Fina...
Do you wonder why so many students wear nice clothes, have money to spare and enjoy tons of free time? Well, they sell on Stuvia! Imagine your study notes being downloaded a dozen times for $15 each. Every. Single. Day. Discover all about earning on Stuvia