What is gcp - Study guides, Class notes & Summaries

According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site? a. CV of investigator and Clinical Trial Authorization (CTA) b. Ethics Committee Approval and signed protocol c. CTA and Ethics Committee Approval d. CTA, Ethics Committee Approval and signed protocol correct answersc. CTA and Ethics Committee Approval What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify ...

RAC Matrix Test Bank Complete Questions and Correct Answers (Verified Answers) 2024 Latest Update [Q]The following are adverse drug experience except: [A]Use of drug in professional practice [B]Drug overdose [C]Drug abuse or withdrawal [D]Birth defect - Answer- [D]Birth defect [Q]For drugs, periodic reports must be submitted to the agency: [A]monthly for the first 2 years after market approval [B]quarterly for the first 3 years after market approval [C]semi-annually for the fir...

GCP Architect Practice Exam Questions. What works with Storage Transfer Service? AWS S3 bucket, Google Cloud Storage bucket, HTTP/HTTPS location Cloud Storage class for once per 30 days access. Nearline App Engine environment for rapid scaling and scaling down to zero. App Engine standard environment Best practices for smoother application development. -Blue-green model -Split application into microservices Service for analyzing up to petabytes of data analytics usi...

What is Snowflake? (key features) correct answers Analytic data warehouse SaaS offering - No hardware/installation/patching - No ongoing maintenance/tuning - Can't run privately (on-prem/hosted) Runs completely in the Cloud (AWS, Azure, GCP) - Has its own VPC Decoupled compute and storage (scaled compute does not need scaled storage) Snowflake Pricing (what determines unit cost, pricing model, editions features) correct answers Unit costs for Credits and data storage determined ...

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 ...

GCP- Social and Behavioral Research Best Practices for Clinical Research Questions and Answers | Latest Update | 2024/2025 | Already Passed What could you say in response to someone who says Good Clinical Practice (GCP) is mostly about curbing abuses by unscrupulous researchers? a. That's correct, GCP is all about strict rules b. That's not true, GCP is more focused on participant behavior c. It's true that GCP was developed to address concerns about unethical behavior, but it'...

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...

According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site? a. CV of investigator and Clinical Trial Authorization (CTA) b. Ethics Committee Approval and signed protocol c. CTA and Ethics Committee Approval d. CTA, Ethics Committee Approval and signed protocol - Answer- c. CTA and Ethics Committee Approval What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify (lega...

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 ...

US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed Describe the purpose of a New Drug Application (NDA). The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical in the U.S. What is the purpose of a combination product in regulatory terms? It involves two or more regulated components, such as a drug and device, that work together. Explain what an Orphan Drug Designation provides to a company. It grants incentives lik...