Investigators brochure - Study guides, Class notes & Summaries
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ACRP CP Practice Questions and Answers (2023 - 2024) With Complete Solution
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What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - Try to obtain the subject's reason for withdrawal. 
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - Validation, accuracy, reliability, completeness 
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - maintain an audit trail, data trail, and edit trail. 
A research subje...
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Certified Clinical Research Professional (CCRP) Exam 100% Pass
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Certified Clinical Research Professional (CCRP) Exam 100% Pass 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 informa...
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Certified Clinical Research Professional (CCRP) Exam Already Passed
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Certified Clinical Research Professional (CCRP) Exam Already Passed 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 in...
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Certified Clinical Research Professional (CCRP) Exam Study Guide.
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Certified Clinical Research Professional (CCRP) Exam Study Guide. 
When isn't an IND application needed? - correct answer 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) - correct 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 res...
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CITI Good Clinical Practice (US only Drug or Device Research) Exam Questions with Correct Answers
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Which of the following are the three principles included in the Belmont Report? Correct Answer Respect for Persons, Beneficence, Justice. 
 
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Correct Answer Determining that the study has maximized benefits and minimized risks. 
 
Which of the following best describes the principle of informed consent as described in the Belmont Report? Correct Answer Information, comprehen...
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ACRP CP PRACTICE QUESTIONS WITH ANSWERS 2023
- Exam (elaborations) • 2 pages • 2024
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What would be the first priority for an investigator when a subject wishes to withdraw 
prematurely from the trial? - Answer Try to obtain the subject's reason for withdrawal. 
CRO recently switched from paper CRF to an EDC system. The EDC system must 
conform to the established requirements for: - Answer Validation, accuracy, 
reliability, completeness 
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - 
Answer maintain an audit trail, data trail, and edit...
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SoCRA Certification Exam 2023 with complete answers
- Exam (elaborations) • 12 pages • 2023
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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...
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RAC Exam Prep - EU MDD-AIMDD & MDR
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RAC Exam Prep - EU MDD-AIMDD & MDR 
Similar but more detailed than the Essential Requirements - ANS-General Safety and Performance 
Requirements 
This ISO standard includes the most recent update to specific medical device companies quality 
management system? - ANS-13485:2016 
Which entity affixes it's identification number near the CE Mark? - ANS-Notified Body, if involved in the 
conformity assessment 
Un-classified devices not requiring CE mark - ANS-Custom-made, Investigational, 
Compa...
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CCRC EXAM SOLVED 100% CORRECT!!
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CCRC EXAM SOLVED 100% CORRECT!! 
 
Protocols 
1) General Information 
2) Background info 
3) Trial objectives and purpose 
4) Trial design 
5) Selection and withdrawal of subjects 
6) Treatment of Subjects 
7) Assessment of Efficacy 
8) Assessment of Safety 
9) Statistics 
10) Source Data/Docs 
11) Quality control/assurance 
12) ethics 
13) data handling and record keeping 
14) financing and insurance 
15) publication policy 
16) supplements 
Phase 1 
-intro of new drug/investigational product i...
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ACRP CP PRACTICE QUESTIONS And ANSWERS 2023/2024 100% CORRECT!
- Exam (elaborations) • 3 pages • 2023
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ACRP CP PRACTICE QUESTIONS And ANSWERS 2023/2024 100% CORRECT! 
 
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER-Try to obtain the subject's reason for withdrawal. 
 
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - ANSWER-Validation, accuracy, reliability, completeness 
 
Part of a sponsor's responsibility pertaining to electronic trial data ha...
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