Study guides, Class notes & Summaries
Looking for the best study guides, study notes and summaries about ? On this page you'll find 516 study documents about .
Page 3 out of 516 results
Sort by
-
SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers
- Exam (elaborations) • 10 pages • 2024
-
- $7.99
- + learn more
Which of the following is a disclosure of financial interests form? - CORRECT 
ANSWER-FDA Form 3455 
Which of the following is a certification of financial interest form? - CORRECT 
ANSWER-FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit 
the following form: - CORRECT ANSWER-FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - 
CORRECT ANSWER-Investigational New Drug Application (1571) 
In...
-
Socra Exam Prep Test 2024- with 100% Correct Answers ( A Graded)
- Exam (elaborations) • 25 pages • 2024
- Available in package deal
-
- $13.49
- + learn more
Laws - ANSWER passed by national legislative bodies; establish authority of national regulatory 
body 
Regulations - ANSWER Passed by regulatory authorities; controls how medical products are 
investigated and approved; have effect of law 
guidance - ANSWER "current thinking" of regulatory bodies; non-binding 
ICH - ANSWER Developed to keep people doing things the same way across the world; 
international effort to harmonize the technical requirements for product registration
-
SOCRA EXAM 2024- with 100% Correct Answers ( A Graded)
- Exam (elaborations) • 50 pages • 2024
- Available in package deal
-
- $13.49
- + learn more
SOCRA EXAM 2024- with 100% Correct Answers ( A 
Graded) 
Electronic signature are currently accepted for any and all records, paper or electronic form. 
True or False? - ANSWER False. The general provisions for electeonic signature criteria apply to 
records that are 
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form 
ii. The criteria do not apply to paper records that are or have been transmitted by electronic 
means. 
If the electronic records meet the c...
-
SOCRA Practice Test - with 100% Correct Answers ( A Guaranteed)
- Exam (elaborations) • 14 pages • 2024
- Available in package deal
-
- $12.89
- + learn more
Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 
Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit the 
following form: - ANSWER FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER 
Investigational New Drug Application (1571)
-
Socra CCRP Exam Prep Test 2024- with 100% Correct Answers ( A Graded)
- Exam (elaborations) • 6 pages • 2024
- Available in package deal
-
- $12.24
- + learn more
Contract Research Organization - ANSWER A person or an organization (commercial, academic, 
or other) contracted by the sponsor to 
perform one or more of a sponsor's trial-related duties and functions. 
When a short form is used for informed consent the witness must sign the short form or the 
summary? - ANSWER False-they must sign both 
What is FDA form 3454 - ANSWER Certification Financial Interests and Arrangements of Clinical 
Investigators
Get paid weekly? You can!
-
SoCRA Certification Exam - with 100% Correct Answers ( A Graded)
- Exam (elaborations) • 17 pages • 2024
- Available in package deal
-
- $12.99
- + learn more
Biometrics - ANSWER 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 - ANSWER 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) 
Digital Signature - ANSWER An electronic signature...
-
SOCRA CCRP EXAM 2024- with 100% Correct Answers
- Exam (elaborations) • 15 pages • 2024
- Available in package deal
-
- $12.89
- + learn more
A patient received an initial dose and had no initial reaction. The protocol says the patient 
needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - 
ANSWER 444mg^3/m 
Which countries are included in the ICH GCP? - ANSWER European Union, Japan, United States, 
Canada and Switzerland 
What is the monitor not responsible for? 
A) Patient information 
B) Sponsor SOP 
C) Protocol/ICF 
D) Reporting to IRB - ANSWER
-
SOCRA FDA timelines TEST - with 100% Correct Answers
- Exam (elaborations) • 7 pages • 2024
-
- $12.24
- + learn more
If immediate use of the test article (exception) is used to preserve the life of a subject 
and time is not sufficient to obtain IC, within X an independent physician should review 
the use of the article - ANSWER 5 days 
If an article is used in an exempt way, this should be reported to the IRB in X after the 
use of the article - ANSWER 5 days 
Emergency use of a test article must be reported to the IRB in X time. Any subsequent 
use is subject to IRB review - ANSWER 5 days
-
SOCRA (CCRP) Exam Practice Questions and Answers 2024
- Exam (elaborations) • 2 pages • 2024
-
- $7.99
- + learn more
The Belmont Report's principle of respect for persons incorporates at least two ethical 
convictions: first, that individuals should be treated as autonomous agents, and second, 
that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to 
protection. 
Which of the following is an example of how the principle of beneficence can be applied 
to a study employing human subjects? - CORRECT AND ANSWER-Determining that 
the study has a maximization of benefits and a minimization ...
-
SOCRA TEST 1 QUESTIONS AND CORRECT ANSWERS
- Exam (elaborations) • 46 pages • 2024
- Available in package deal
-
- $8.00
- + learn more
SOCRA TEST 1 QUESTIONS AND CORRECT ANSWERS
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