Pma 2 review - Study guides, Class notes & Summaries
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US RAC Review Questions RAPS Modules 2024 with complete solution
- Exam (elaborations) • 29 pages • 2024
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US RAC Review Questions RAPS Modules 
2024 with complete solution 
In which situation is an IND not required? 
A) You intend to conduct a clinical trial with an investigational new drug 
B) You intend to conduct a clinical trial with an approved drug to support a marketing 
application for a new indication 
C) You intend to collect blood samples from subjects to look for biomarkers or pharmacogenetic 
information 
D) You intend to conduct a clinical trial using 2 of your approved drugs in a new ...
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RAC Practice Exam 1 Questions and Answers New Version 2024 Complete
- Exam (elaborations) • 22 pages • 2024
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RAC Practice Exam 1 Questions and Answers 
New Version 2024 Complete 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic re...
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FDA Time Frames (Device) RAC Exam Questions and Answers 100% Solved
- Exam (elaborations) • 7 pages • 2023
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FDA Time Frames (Device) RAC Exam Questions and Answers 100% Solved Facility Registration - Devices - within XX days of application or manufacturing 30 days 
Facility Re-Registration - Devices, Drugs & Biologics Annual 
GLP & GCP Record Retention 5 Years - from application or 2 Years - from approval or termination date 
IND/IDE (GCP) - Progress Report - Reporting requirements 
Sponsor report to FDA & IRB Investigator reports to Sponsor & IRB Annual - 60 days from anniversary 
IND & IDE - time al...
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SOCRA CCRP Exam Questions and Answers Rated A
- Exam (elaborations) • 13 pages • 2024
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SOCRA CCRP Exam Questions and Answers Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 
The Three Principles of the Belmont Report respect for persons, beneficence, justice 
Application of Respect for Persons informed consent (autonomy, choose for themselves) 
Application of Beneficence risk/benefit analysis 
Application of Justice appropriate selection of patients (equality) 
Language Level ICF 6th-8th grade 
8 basic elements of ICF 1....
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RAC Practice Exam Latest Updated 2024 With Complete Solutions
- Exam (elaborations) • 23 pages • 2024
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RAC Practice Exam Latest Updated 2024 With Complete Solutions 
 
You have modified your 510(k)-cleared device with a Special 510(k). In which case 
would a Special 510(k) not be appropriate for the device? -You have changed the 
primary mechanism of action. 
Which Premarket Approval Application (PMA) supplements are NOT subject to user 
fee exemption? - Real Time Supplement 
A medical device company allows its sales force to maintain a product inventory in 
the field. The device has an expir...
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2014 US RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed
- Exam (elaborations) • 141 pages • 2024
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2014 US RAC Practice Exam Questions 
and Answers | Latest Update | 2024/2025 
| Already Passed 
Which regulatory pathway allows for faster approval of drugs that address unmet medical needs 
in serious conditions? 
A) Priority Review 
B) Orphan Drug Designation 
C) Accelerated Approval 
D) Fast Track Designation 
Which document must be provided to participants to ensure they understand the risks and 
benefits of a clinical trial? 
A) Investigator’s Brochure 
B) Informed Consent Form 
C) Clinic...
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RAC Practice Exam 1 Questions and Answers New Version 2024 Complete
- Exam (elaborations) • 22 pages • 2024
- Available in package deal
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- $13.49
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RAC Practice Exam 1 Questions and Answers 
New Version 2024 Complete 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic re...
-
RAC Practice Exam 1 Latest 2024 with complete solution
- Exam (elaborations) • 22 pages • 2024
- Available in package deal
-
- $12.49
- + learn more
RAC Practice Exam 1 Latest 2024 with 
complete solution 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic records. 
D Est...
-
RAC Practice Exam 1 Latest 2024 with complete solution
- Exam (elaborations) • 22 pages • 2024
- Available in package deal
-
- $13.49
- + learn more
RAC Practice Exam 1 Latest 2024 with 
complete solution 
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic 
records and electronic signatures)? 
A Manually generated timestamped audit trails to record the date and time of operator entries 
and actions that create, modify or delete electronic records. 
B Validation of systems to ensure accuracy 
C Authority checks to ensure that only authorized personell can create, modify or delete 
electronic records. 
D Est...
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RAC Devices Practice Exam 2023/2024 with Complete Solutions
- Exam (elaborations) • 6 pages • 2023
- Available in package deal
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- $10.49
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A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 
0 A PMA 
1 A Special 510(k), 
2 An Individual Device Exemption (IDE), 
3 An Annual Report for a PMA - ANSWER-A Special 510(k) 
 
A company wishes to expand existing labeling for a medical device to include a new indication for use. What action should the regulatory professional take FIRST? - ...
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