Irb approval Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about Irb approval? On this page you'll find 1576 study documents about Irb approval.
All 1.576 results
Sort by
-
ACRP Practice Exam 2023 Questions and Answers
- Exam (elaborations) • 8 pages • 2023
-
- $10.00
- 2x sold
- + learn more
A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% 
 
To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: 
AST 5-65 ALT 5-35 BUN 4-25 
Creat 0.5-1.2...
-
CCRP Exam answered 2023/24 100% verified GRADED A
- Exam (elaborations) • 32 pages • 2023 Popular
-
- $3.99
- 2x sold
- + learn more
CCRP Exam Questions Bank | 273 Questions with 100% Correct Answers 
How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answer 5 working days 
How many members must sit on an IRB? - correct answer 5 
How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research 
What are the criteria for IRB approval of research? (7) - correct answer 1. Risks to subjects are minimized 
2. Risks are reasonable in relation t...
-
SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
- Exam (elaborations) • 356 pages • 2023
-
- $13.99
- 2x sold
- + learn more
SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide 
 
Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? 
 
Answer: 
1) Progress of investigations under IND 
2) Secure compliance or discontinue investigators that are not compliant and notify FDA 
3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 
4) Notify FDA, all IRBs and all investigators if drug presen...
-
MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) | Latest 2023/2024
- Exam (elaborations) • 127 pages • 2023
- Available in package deal
-
- $13.29
- 1x sold
- + learn more
MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) | Latest 2023/2024 
5 ️ The minimum number of IRB members 
Subjects cannot be enrolled until IRB/IEC approval has been obtained 
️ In a non-emergency situation, under which of the following 
conditions, if any, may subjects be enrolled into a study prior to IRB/IEC 
approval? 
The Sponsor ️ The responsibility for ensuring that the investigator 
understands a clinical trial lies with: 
A subject has been enrolled on a s...
-
CCRP Exam Questions Bank | 273 Questions with 100% Correct Answers
- Exam (elaborations) • 31 pages • 2022
-
- $12.49
- 11x sold
- + learn more
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. Informed ...
Get paid weekly? You can!
-
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...
-
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...
-
NAPSR/CNPR Exam 2023 with 100% correct answers
- Exam (elaborations) • 22 pages • 2023
- Available in package deal
-
- $15.49
- 1x sold
- + learn more
Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for sale. 
True 
 
 
 
Average review time for a new drug 
18 months 
 
 
 
Sales Team 
Pg 7 
 
 
 
The "engine of innovation," focused on discovering or inventing promising new product. 
Research & Development 
 
 
 
This includes supply chain, manufacturing, trade, and distribution functions of the business. 
Manufacturing & Operations 
 
 
 
In 2012, FDA r...
-
Certification for IRB Professionals (CIP) Exam Questions and Answers (100% Correct Answers)
- Exam (elaborations) • 9 pages • 2023
-
- $12.49
- 1x sold
- + learn more
According to the Belmont Report, respect for persons usually demands that subjects... enter into research voluntarily & with adequate information According to the Belmont Report, the moral requi rement that there be fair outcomes in the selection of research subjects, expresses the principle of: Justice A poorly designed protocol is considered unethical because... research subjects may be put at risk or inconvenienced for insufficient reason When should an IRB suspend or terminate approval of re...
-
MEGA SOCRA CCRP EXAM CONTENT| 790 QUESTIONS (100 PAGES)| WITH COMPLETE SOLUTION
- Exam (elaborations) • 100 pages • 2022
- Available in package deal
-
- $13.99
- 2x sold
- + learn more
5 Correct Answer: The minimum number of IRB members 
 
Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
 
The Sponsor Correct Answer: The responsibility for ensuring that the investigator understands a clinical trial lies with: 
 
A subject has been enrolled on a study and was randomized to the non-treatment arm. T...
-
ICH GCP for CCRC Exam Prep|543 Questions and Answers 2023 Graded A+.
- Exam (elaborations) • 53 pages • 2023
-
- $10.99
- 2x sold
- + learn more
ICH GCP for CCRC Exam Prep|543 Questions and Answers 2023 Graded A+. 
Adverse Drug Reaction (ADR) Correct Answer: All noxious and unintended responses to a 
medicinal product related to any dose 
E6(R1) 1 Correct Answer: Glossary of terms 
Adverse Event (AE) Correct Answer: Any untoward medical occurrence in a patient or clinical 
investigation subject administered a pharmaceutical product and which does not necessarily have 
a causal relationship with this treatment--any unfavorable and uninten...
That summary you just bought made someone very happy. Also get paid weekly? Sell your study resources on Stuvia! Discover all about earning on Stuvia