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Which of the following is a disclosure of financial interests form? - CORRECT ANSWER-FDA Form 3455 Which of the following is a certification of financial interest form? - CORRECT ANSWER-FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - CORRECT ANSWER-FDA Form 3455 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - CORRECT ANSWER-Investigational New Drug Application (1571) In...

Biometrics - CORRECT ANSWER-A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - CORRECT ANSWER-An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - CORRECT...

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - CORRECT ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - CORRECT ANSWER-Yes Open system (FDA term) - CORRECT ANSWER-System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (...

Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - CORRECT ANSWER-informed consent (autonomy, choose for themselves) Application of Beneficence - CORRECT ANSWER-risk/benefit analysis Application of Justice - CORRECT ANSWER-appropriate selection of patients (equality) Language Level ...

Electronic Records - CORRECT ANSWER-Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine Electronic Records - Audit Trail - CORRECT ANSWER-Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date and time of entries and actions that create, modify or delete record...

How is the F Migration tool different than change sets? - CORRECT ANSWER-The F Migration Tool allows you to migrate metadata between unrelated organizations, so in that sense it's more powerful than change sets. Unlike the F IDE, the F Migration Tool has no graphical user interface. You choose the components you want to deploy, the server address, and other deployment details by editing control files in a text editor and using command-line arguments. What is the Production Typical De...

What method(s) can be used to develop in one environment and deploy to multiple related Prod environments? Sandbox and change sets Sandbox and managed package Dev Edition org and managed package Dev Edition org and unmanaged package - CORRECT ANSWER-Dev Edition org and managed package Dev Edition org and unmanaged package A sandbox is built from Prod, so anything in a sandbox can only be deployed to that Prod and not some other Prod. Managed packages cannot be built in sandboxes. I ...

Center of Excellence (CoE) - CORRECT ANSWER-A few stakeholders from different functional groups work together to ensure that changes support business goals and follow IT best practices and processes. Release Management Team - CORRECT ANSWER-Responsible for planning, scheduling, and controlling the build, in addition to testing and deploying Releases Governance Framework - CORRECT ANSWER-Improves coordination by ensuring all members of your team are working together to achieve project d...

Center of Excellence (CoE) - CORRECT ANSWER-A few stakeholders from different functional groups work together to ensure that changes support business goals and follow IT best practices and processes. Release Management Team - CORRECT ANSWER-Responsible for planning, scheduling, and controlling the build, in addition to testing and deploying Releases Governance Framework - CORRECT ANSWER-Improves coordination by ensuring all members of your team are working together to achieve project d...

Northern Trail Outfitters (NTO) has acquired a competitor. The agreement is to migrate the acquired company into NTG's Technological Platforms. One of its challenges is to offer a unified customer experience while strengthening the relationship with its customers. The business analyst (BA) has been asked to translate the business objectives and assemble an improved and standard customer experience. Which strategy should the BA use to accomplish the goal? A. Understand business objec...