Pma 2 review - Study guides, Class notes & Summaries

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 ...

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...

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...

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....

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...

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...

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 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 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...

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? - ...