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NEW QUESTION: 1
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for
review and approval. The regulatory authority issues the company a written commitment that if the studies
are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and
safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre-specified
criteria, the company receives a letter from the regulatory authority stating that it no longer believes that
the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
A. Request a meeting with the regulatory authority to discuss the application.
B. Review the regulatory guidelines to determine how to proceed.
C. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the
application.
D. Consult with the legal department to discuss the best course of action.
Answer: A

NEW QUESTION: 2
You have written a server-side Node.Js application and a web application with an HTML/JavaScript front end that uses the Angular.js framework.
The server-side application connects to an Amazon Redshift cluster, issues queries, and then returns the results to the front end for display.
Your user base is very large and distributed, but it is important to keep the cost of running this application low.
Which deployment strategy is both technically valid and the most cost-effective?
A. Upload the HTML, CSS, images, and JavaScript for the front end to an Amazon Simple Storage Service (S3) bucket.
Create an Amazon CloudFront distribution with this bucket as its origin. Use AWS Elastic Beanstalk to deploy the Node.js application.
Launch an Amazon Redshift cluster, and point your application to its JDBC endpoint.
B. Upload the HTML, CSS, images, and JavaScript for the front end, plus the Node.js code for the server-side application, to an Amazon S3 bucket.
Create a CloudFront distribution with this bucket as its origin.
Launch an Amazon Redshift cluster, and point your application to its JDBC endpoint.
C. Deploy an AWS OpsWorks stack with three layers: a static web server layer for your front end, a Node.js app server layer for your server-side application, and a Redshift DB layer for your Amazon Redshift duster.
D. Upload the HTML, CSS, images, and JavaScript for the front end to an Amazon S3 bucket.
Use AWS Elastic Beanstalk to deploy the Node.js application.
Launch an Amazon Redshift cluster, and point your application to its JDBC endpoint.
E. Deploy an AWS Elastic Beanstalk application with two environments: one for the Node.js application and another for the web front end.
Launch an Amazon Redshift cluster, and point your application to its Java Database Connectivity (JDBC) endpoint.
Answer: A

NEW QUESTION: 3
프로젝트의 핵심 팀이 부분적으로 완료된 프로젝트에 재 할당되었습니다. 새로운 팀은 범위를 과소 평가하고 작업이 제대로 진행되고 있다고 지속적으로 보고했습니다. 주요 결과물이 마감되기 전날 프로젝트 관리자는 제품이 실제로 일정보다 10 일 늦게 배송 될 것이라는 사실을 알게 되었습니다.
이 상황을 피하기 위해 프로젝트 관리자는 무엇을 할 수 있었습니까?
A. 위험 관리 계획에 정의 된 완화를 사용하여 새 팀을 효과적으로 통합했습니다.
B. 스톰 킹 단계에서 일정을 빠르게 추적하기 위해 마감일 며칠 전에 대기 리소스를 유지했습니다.
C. 기한을 맞추기 위해 일정을 어긋나게 해야 하는 경우 팀이 추가 리소스를 확보 할 수있는 권한을 부여했습니다.
D. 범위를 과소 평가하여 복구하는 데 추가 시간을 허용하는 보다 강력한 일정을 만들었습니다.
Answer: D

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