Gcp 5 - Study guides, Class notes & Summaries

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

FDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFDA Time Frames (Device) RAC Exam Questions and Answers 100% VerifiedFacility Registration - Devices - within XX days of application or manufacturing - ANSWER-30 days Facility Re-Registration - Devices, Drugs & Biologics - ANSWER-Annual GLP & GCP Record Retention - ANSWER-5 Years - from...

Nuremberg Code (1947) Correct Answer A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points Correct Answer 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right...

Resource Hierarchy - Parent/Child Relationship structure - Resembles a file system - Top-down policy inheritance with policy controlled by IAM - Each child object can only have one parent - Org -> Folders (Optional) -> Projects -> Resources Organization - Root node - Organization Admin Role created - Full power to efit any/all resources Notable Organization Roles - Org. Policy Admin: Broad control over all cloud resources - Project Creator: Find-grained control of project cr...

SOCRA - CCRP (high level)Exam Review Questions. Nuremberg Code (1947) - correct answer A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - correct answer 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. quali...

SOCRA CCRP (High Level) Exam with Verified Answers | Latest 2023/2024 Nuremberg Code (1947) ️ A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points ️ 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified...

Declaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of a clinical trial. Covers human rights, standards on trial conduct, roles and responsibilities (IRB, PI, sponsor, monitors). GCP v Declaration of Helinski - ANSWER -GCP lacks moral principles an...

CCRC Exam Prep Questions With 100% Correct Answers. What is an Adverse Event (AE) ? 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. (ICH GCP E6 1.2) What is an Adverse Drug Reaction (ADR)? All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) What is the definition of Severity? intensity What are t...

You are performing a semi-annual capacity planning exercise for your flagship service. You expect a service user growth rate of 10% month-over-month over the next six months. Your service is fully containerized and runs on Google Cloud Platform (GCP), using a Google Kubernetes Engine (GKE) Standard regional cluster on three zones with cluster autoscaler enabled. You currently consume about 30% of your total deployed CPU capacity, and you require resilience against the failure of a zone. You want...

Google Associate Cloud Engineer Exam Questions and Answers 2024 What is the purpose of a VPC ? -Answer-Connects resources to each other and the internet. networks are ___ , subnets are ___ -Answer-global,regional How would you increase the size of a subnet? -Answer-expanding IP addresses What is the purpose of a pre-emptible VM? -Answer-permission to terminate if resources are needed elsewhere. Also very cheap What is cloud DNS -Answer-translates hosts name to address using google edge ...