RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 4 )

• Correct answer: D — Promote off-label use to a carefully selected patient population.

• Conditional approval means confirmatory studies are still required. To minimize risk during this period, you should implement risk minimization actions that keep use within approved terms.
• Labeling for appropriate populations ensures clinicians and patients know exactly who the product is intended for.
• Educating patients and healthcare providers reduces misuse and misinterpretation of how to use the product.
• Delaying product launch limits patient exposure to potential unknown risks until safety/efficacy are confirmed.
• Promoting off-label use is least effective (and inappropriate): it increases risk, bypasses approved indications, and undermines regulatory commitments. Off-label use lacks the evidentiary basis and regulatory safeguards of approved indications.

• Highly polished, organization-wide presentations
• Advanced dashboard design and customization
• Broader business-user distribution and interaction
• Specialized BI governance and modeling features

• Accept terms of use
• Enter a temporary code or credentials
• Provide basic registration information

• Enterprise authentication — Authenticates organizational users, often with centralized identity services; it is not specifically designed for temporary guest access.
• Ad hoc network — A temporary device-to-device network, not an authentication process.
• WPA3 — A wireless security standard. It protects Wi-Fi access but does not provide the web-based temporary access workflow described here.

• Products ? OrderHistory: Products is 1, OrderHistory is many (1:*)

• Date ? OrderHistory: Date is 1, OrderHistory is many (1:*)

Statement 1 — Correct

Statement 2 — Correct

• Espionage: Stealing information for intelligence or competitive purposes.
• Data exfiltration: Unauthorized removal or transfer of data.
• Nation-state attack: A sophisticated attack sponsored by a government.
• Shadow IT: Unapproved technology or access methods used by employees.

• No servers or database infrastructure to provision.
• Uses standard SQL.
• Supports formats such as JSON, CSV, Parquet, and ORC.
• You typically define the table structure with AWS Glue Data Catalog or Athena’s own schema definitions.
• Charges are generally based on the amount of data scanned, so partitioning and columnar formats can reduce cost.
• It does not copy the data into a separate database; it reads the files in S3 when you run a query.

• The vulnerability scan identifies a vulnerability.
• The administrator verifies that the vulnerability is not present.
• Therefore, the scan produced a false positive.

• True positive: A vulnerability is reported and genuinely exists.
• False negative: A vulnerability exists, but the scan fails to detect it.
• True negative: No vulnerability exists, and the scan correctly reports no issue.

• VPC: A logically isolated virtual network within a cloud provider; it describes network design, not the user-access model.
• NFV: Runs network services as software instead of on dedicated hardware.
• SaaS: Delivers software over the internet. Although the application may be delivered as SaaS, the question emphasizes its availability to multiple user groups, which points to multitenancy.

• You can configure different pre-shared keys for different device groups.
• All cameras could use one key.
• All scanners could use another key.
• Each key can be associated with an appropriate role or access policy.

• Azure DevOps Analytics views are accessed through the Power BI Azure DevOps (Boards only) connector.
• This connector authenticates directly to Azure DevOps Services and lets you select an Analytics view.
• Analytics views allow filtering and shaping data in the cloud before Power BI loads it.
• Azure DevOps Server (Boards only) is for an on-premises Azure DevOps Server instance, not Azure DevOps cloud.
• A generic OData Feed connection can access OData endpoints, but it is not the purpose-built connector for Azure DevOps Analytics views.
• “OData queries” describes the underlying technology or query approach, not the most appropriate Azure DevOps connector choice here.

• CHAP: Uses a challenge-response exchange, so the password is not directly transmitted.
• IPsec: Provides authentication, integrity, and encryption for IP communications.
• EAP: An authentication framework that supports stronger methods, such as certificates or token-based authentication.

• C — Create a form extension and implement validation

• D — Use Chain of Command (CoC) with a form extension class

text 
user<TAB>action<TAB>status

text 
user|action|status

• Colons: Although colons commonly appear in log data, they are not a supported delimiter choice in the FX workflow described by this exam question.
• Spaces: Spaces are not treated as a supported delimiter for this extraction method; ordinary text often contains variable spacing.

1. Wireless AP

1. Router

1. Firewall

1. Device placement

• SQL injection
• Cross-site scripting (XSS)
• Malicious or malformed web requests
• Some application-layer attacks

• Layer 4 firewall: Filters based mainly on IP addresses, ports, and transport protocols; it cannot deeply inspect web application content.
• NGFW: Provides advanced network filtering and may include application awareness, but a WAF is more specifically designed to protect web applications.
• UTM: Combines several security functions in one appliance, but it is not the most targeted solution for a web portal.

• Wireshark captures packets and allows you to examine their contents, potentially revealing usernames and passwords sent without encryption.
• Netcat creates network connections and can send or receive data, but it is not primarily a packet-analysis tool.
• Nessus scans for known vulnerabilities and configuration issues; it generally would not prove that credentials are visible in transit.
• Nmap performs network discovery and port/service scanning, not detailed packet-content inspection.

• Determining ISP-assigned address space: Usually involves public reconnaissance, such as WHOIS or regional Internet registry information.
• Bypassing DNS sinkholing: Would require evidence that malicious domains are resolving outside the organization’s sinkhole controls.
• Achieving initial access: DNS log entries alone do not demonstrate compromise or entry.
• Exfiltrating data: DNS tunneling generally involves repeated queries containing encoded or unusually long data, not merely internal host discovery.

• Access List: controls whether a client is allowed or denied.
• Connect List: controls which wireless networks/APs a station may connect to.

• Deterrent control: The signs warning people they may be filmed discourage unauthorized or malicious behavior. They may prevent incidents by influencing behavior, but their primary purpose is to deter.
• Detective control: The CCTV system monitors and records activity so security personnel can identify suspicious or unauthorized actions.

• Preventive: Blocks or prevents an incident, such as a lock or access-control system.
• Corrective: Fixes or restores systems after an incident.
• Directive: Tells people what they must do, typically through policies or procedures.
• Compensating: Provides an alternative control when the preferred control cannot be used.

• Key-based authentication: Provides an endpoint secured with API keys.
• Real-time REST access: Supports online inference through an HTTP/REST endpoint.
• No VM vCPU quota consumption: Microsoft hosts and manages the underlying infrastructure, so your subscription’s VM quota isn’t used.

• Batch: Intended for asynchronous, large-volume processing rather than real-time requests.
• Self-hosted container: You manage the infrastructure and typically need compute resources and quota.
• Standard: This is not the clearest deployment type for the stated requirements; the specific Foundry option is serverless API.

• A — If there is no demand, there should be no production.

• B — Not all sales equal profit.

• C — Stocking up on inventory is bad for business.

• D — All costs, except materials, are considered fixed.

• E — Departments should operate at full capacity regardless of bottlenecks.

• Data only needs to be current at 7 AM each day, so scheduled refresh is sufficient.
• Import mode provides the fastest report interaction because data is stored in Power BI’s in-memory engine.
• It supports row-level security (RLS), including the USERNAME() filter.
• You can limit the imported data to the current year and previous three years to reduce model size.
• DirectQuery would generally provide slower visual response times and is unnecessary here.
• Dual is mainly useful in composite models where some tables use DirectQuery and others use Import. That is not required by this scenario.
• Live connection is not appropriate because you are creating the semantic model.

• Understating expenses and liabilities
• Overstating profit
• Misleading users of the financial information
• Potentially breaching integrity, objectivity, and professional competence and due care

• Form layout
• Related lists
• Dictionary settings
• UI policies
• Client scripts
• Views and field visibility

• Personalization usually affects only the individual user.
• System configuration can affect other users, depending on its scope and conditions.

• The product is already in production.
• The organization is examining the product’s functions and cost drivers.
• The objective is to reduce cost without reducing perceived value or required quality.

• Kaizen costing focuses on continuous, usually incremental, cost reductions during the manufacturing stage. It is not specifically the systematic examination of a product’s functions.
• Standard costing compares actual costs with predetermined standards; it is a control technique, not a product redesign method.
• Process innovation concerns developing significantly improved production processes, rather than analysing the product’s functions and value.

• Treatment one – easier to prepare: Convenience for the accounting team is not the main objective of financial reporting.
• Treatment two – fair representation: This is the correct choice because financial statements must faithfully represent the underlying transaction and its economic substance.
• Treatment three – maximises profit: Accounting policies must not be selected simply to manipulate or inflate reported profit.
• Treatment four – easier to understand: Understandability is important, but it cannot justify presenting information that is less faithfully represented.

• Admin access to the deployment pipeline
• Contributor access to the Development and Test workspaces
• Viewer access to the Production workspace

• Custom domain: miami.weyland.com requires a paid App Service tier; Free and Shared are unsuitable.
• Two instances: Standard supports scaling to multiple instances.
• SSL: Standard includes SSL support.
• 12 GB storage: Basic provides only about 10 GB, so it does not meet the requirement. Standard provides substantially more storage.
• Cost minimization: Standard is the lowest tier among the choices that satisfies all requirements.

• A. PsFile — Correct: Displays files opened remotely on a system. This reveals shared resources and user activity.
• B. UserInfo — Correct: Gathers information about user accounts, supporting account and privilege enumeration.
• C. PsPasswd — Answer key lists it: This is questionable. PsPasswd is primarily used to change passwords remotely, not enumerate information. The key may classify it broadly as a Windows account-management tool, but it is not a strong enumeration example.
• D. WinSSLMiM — Incorrect: Used for SSL man-in-the-middle activity, not enumeration.

• /27 (255.255.255.224)

• /26 (255.255.255.192)

• /25: Creates only 2 subnets, not 3
• /28: Provides only 14 usable hosts per subnet

• CSIRT: A Computer Security Incident Response Team that handles and coordinates incident response.
• CVSS: A scoring system used to rate the severity of vulnerabilities.
• SOAR: Security Orchestration, Automation, and Response technology used to automate security workflows.

• Third-party attestation: Provides independent confirmation, often for formal compliance reporting, but is not usually performed frequently.
• Penetration testing: Attempts to exploit vulnerabilities; it focuses on technical security, not overall compliance procedures.
• Vulnerability scans: Identify known technical weaknesses in systems, but do not evaluate whether policies and processes meet compliance requirements.

• \Pipeline1
• \Folder1\Lakehouse1

• Pipeline1 remains at the workspace root in Workspace1, so it is deployed to the root of Workspace2.
• Lakehouse1 was moved into Folder1, so its full path is preserved as \Folder1\Lakehouse1.
• Fabric deployment pipelines preserve folder paths because an item’s full path is treated as part of its name.

• Accept: Acknowledging the risk without taking additional action.
• Transfer: Moving the risk’s financial impact to a third party, such as an insurer.
• Mitigate: Reducing the likelihood or impact through controls, such as patching or employee training.
• Avoid: Eliminating the activity that creates the risk.

• If the hashes match, the software has likely not changed.
• If they differ, the software was modified or corrupted.

• Encryption: Protects confidentiality by making data unreadable; it does not primarily verify that software was unchanged.
• Baselines: Establish expected configurations or states, but hashing is the specific method for checking file integrity.
• Tokenization: Replaces sensitive data with non-sensitive tokens and is unrelated to software integrity.

• User-generated content: precisa ser coletado, filtrado, anonimizado e rotulado.
• Moderation logs: podem conter dados inconsistentes, informações pessoais e decisões que precisam ser revisadas.
• Content moderation guidelines: são regras ou orientações, não dados diretamente utilizáveis para medir o comportamento do modelo.

• Disabling a compromised account
• Blocking a malicious IP address
• Isolating an endpoint
• Creating or escalating an incident ticket

• Virus signatures: Primarily associated with antivirus or endpoint protection.
• Security agent deployment: Usually handled by endpoint-management or security-agent platforms.
• Vulnerability scanning: Typically performed by vulnerability-management tools.

• The Azure DevOps (Boards only) connector is designed specifically for Azure DevOps Analytics views.
• It authenticates directly to Azure DevOps and lets you select an existing Analytics view.
• Filters defined in the Analytics view are applied by Azure DevOps before Power BI retrieves the data, reducing the amount of data transferred.

• Azure DevOps Server (Boards only) is for on-premises Azure DevOps Server.
• OData Feed can consume OData endpoints, but it is not the dedicated Azure DevOps Analytics-view connector.
• OData queries are not the intended dedicated connector for this requirement.

• Custom domains: Supported by Basic and higher tiers.
• Dedicated compute: Basic and Standard use dedicated virtual machine instances; Free and Shared use shared infrastructure.
• Load balancing between instances: Standard provides scaling across multiple instances with load balancing.
• Storage: Standard provides more storage than Basic.
• Cost: Standard is the least expensive option that satisfies all the stated requirements.

• Free/Shared: Use shared compute and have limited features; they don’t meet the dedicated-compute requirement.
• Basic: Provides dedicated compute and custom domains, but does not provide the required Standard-level multi-instance capabilities in the exam’s feature comparison.

• Proxy server: Acts as an intermediary for requests, but does not necessarily provide an encrypted connection to the corporate network.
• NGFW: A firewall with advanced inspection and filtering capabilities; it may support VPNs but is not the remote-access solution itself.
• Security zone: A logical network grouping based on trust or security requirements, not a method for remote access.

• Physical: Protects facilities or equipment, such as locks and security cameras.
• Technical: Uses technology, such as firewalls, encryption, or access controls.
• Operational: Covers day-to-day actions and processes, such as training, backups, or incident response.
• Managerial: Includes policies, standards, risk assessments, and procedures.

• Namespace: The namespace associated with the code where the checkpoint was set.
• Time: When the checkpoint was captured or executed.

• Exception: Exceptions are viewed through debug logs or execution results, not as the primary Checkpoints tab information.
• Debug Statement: System.debug() output belongs in the Logs tab. A checkpoint captures program state, such as variables and their values, at a specific point in execution.

• A. IDS attack signatures: An IDS primarily detects suspicious network activity; it is not the best control for scanning uploaded documents for malware.
• C. Load balancer: Distributes traffic among servers and improves availability, but does not inspect files for malware.
• D. WAF: Protects web applications against attacks such as SQL injection and command injection. It may help secure the upload function, but malware scanning is the key requirement here.

• Sustainability
• Performance efficiency
• Reliability

• Prevention costs – costs incurred to stop defects occurring, such as staff training, quality planning and supplier evaluation.
• Appraisal costs – costs of checking whether products meet standards, such as inspection, testing and quality audits.
• Internal failure costs – costs of defects found before delivery to customers, such as scrap, rework and retesting.
• External failure costs – costs of defects found after delivery, such as warranty claims, returns, complaints and product recalls.

• Accept: Acknowledging the risk and choosing not to take additional action.
• Transfer: Shifting the risk or financial consequences to another party, such as an insurer.
• Mitigate: Reducing the likelihood or impact through controls, such as patching or access restrictions.
• Avoid: Eliminating the activity that creates the risk.

• T?o m?t Systems Manager Automation runbook d? ch?y l?nh kh?i d?ng l?i ?ng d?ng trên các EC2 instance.
• T?o m?t Amazon EventBridge rule ph?n ?ng khi CloudWatch alarm chuy?n sang tr?ng thái ALARM.
• Ð?t Automation runbook làm target c?a EventBridge rule.

1. Log c?a ?ng d?ng du?c ghi vào CloudWatch Logs.
2. CloudWatch alarm phát hi?n nhi?u l?i liên quan d?n vi?c restart.
3. Alarm chuy?n sang tr?ng thái ALARM.
4. EventBridge nh?n s? ki?n thay d?i tr?ng thái này.
5. EventBridge g?i Systems Manager Automation runbook.
6. Runbook restart ?ng d?ng trên các EC2 instance, không restart c? instance.

• A: SNS không tr?c ti?p g?i Systems Manager Automation runbook nhu m?t target native.
• B: Lambda có th? th?c hi?n vi?c restart, nhung ph?i t? x? lý vi?c xác d?nh instance và ch?y l?nh t? xa.
• C: Lambda ch? làm trung gian d? g?i runbook, không c?n thi?t vì EventBridge có th? g?i runbook tr?c ti?p.

• Required response and resolution times
• Availability or uptime targets
• Performance standards
• Support obligations
• Remedies or penalties for failing to meet the terms

• SOW (Statement of Work): Defines the project’s scope, tasks, deliverables, and schedule.
• MOA (Memorandum of Agreement): Describes agreed responsibilities between parties, often for a specific activity.
• MOU (Memorandum of Understanding): Records a mutual understanding or intention, usually less formal than a contract.