RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 7 )

• 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.

• terraform init is normally required first, especially for a new or changed working directory. It installs providers/modules and configures the backend.
• terraform plan previews the proposed changes.
• terraform apply applies those changes. It also creates a plan internally if you have not supplied a saved plan.

text 
terraform init 
terraform validate       # optional but recommended 
terraform plan 
terraform apply

• Third-party attestation: Provides independent validation, but is typically periodic and performed by an external party.
• Penetration testing: Simulates attacks to identify exploitable vulnerabilities; it does not primarily track compliance.
• Vulnerability scans: Identify technical weaknesses, but do not provide a detailed review of procedures or compliance activities.

• Constrained VMs: VMs whose workloads are experiencing resource pressure, such as insufficient CPU or memory. They may need additional resources or optimization.
• Overprovisioned VMs: VMs allocated more CPU, memory, or storage than their workloads require. Their resources may be reclaimed or reduced.

• Underprovisioned VMs: This is not the predefined view identified for this report question.
• Zombie VMs: These are typically inactive or unused VMs and are useful for cleanup, but they are not the two views specifically intended here to identify inefficient resource allocation.

• Design Studio > Emails ? create an email-template folder
• Design Studio > Landing Pages ? create a landing-page-template folder
• Add the relevant assets to each folder
• Right-click the folder and choose Share Folder
• Select the destination workspaces

• A — Securing information assets: This is the responsibility of management and operational/security teams.
• B — Validating protection: Correct. The auditor checks whether controls—such as access restrictions, encryption, retention, and handling procedures—match the asset’s classification.
• C — Ensuring alignment with regulations: Management and legal/compliance functions typically establish classification requirements; the auditor may assess compliance but does not primarily define alignment.
• D — Defining classification levels: This is a management responsibility based on business needs, risk, and regulatory obligations.

• Domain controllers, because the requirement specifically excludes them. However, note that both member servers and domain controllers run Windows Server, so OS targeting alone cannot distinguish them unless the targeting option allows selecting the relevant server role/version. In the usual exam interpretation, target the applicable server OS category.
• Client computers, because they run a client Windows operating system.

• Domain: Targets membership in a domain, not the computer’s operating-system type.
• Security Group: Would require creating and maintaining a group containing all member servers, increasing administrative effort.
• Environment Variable: Not designed to reliably identify member servers.

• MFA adds an additional authentication factor, such as a phone notification or verification code.
• It helps prevent unauthorized sign-ins, even if a password is compromised.
• It does not encrypt, store, or protect credentials used by deployment processes.

• Leaf switches provide access ports for servers, users, and other devices.
• Spine switches provide the backbone between leaf switches.
• Every leaf switch connects to every spine switch, creating a predictable, full-mesh fabric between the two layers.
• Leaf switches do not connect directly to other leaf switches, and spine switches do not connect directly to other spine switches.

• A: Adding both a spine and leaf is unnecessary for simply adding access ports.
• B: It focuses on uplink speed, not the scalable topology.
• D: A single spine connection creates a bottleneck and a single point of failure.

• Atomicity: a write fully succeeds or does not appear.
• Consistency: table state remains valid.
• Isolation: concurrent operations do not corrupt one another.
• Durability: committed changes persist.

• Flexible schemas: common data lakes often support flexible or schema-on-read data.
• Open-source formats: common data lakes commonly use open formats such as Parquet.
• Scalable storage: cloud data lakes already provide scalable storage.

• D — Value analysis: Correct. It examines an existing product to identify ways of reducing its cost while still providing the required functions, quality and reliability.
• E — Kaizen costing: Correct. It involves making continuous, small improvements and cost reductions while the product is already in production.

• Functional analysis: It is not limited to minimizing the cost of the originally defined functions. It examines what functions are required and how they can be provided at the lowest overall cost.
• Value engineering: Usually applies to the design and development of a new product, rather than being a fundamental redesign of existing organisational processes. That description is closer to business process re-engineering.
• Target costing: The target cost is generally established during the product development stage, before production begins. It is not continuously reset while the product is in production.

• JDBC
• SnowSQL
• Snowflake Web Interface (UI)
• ODBC
• Python connector

• Bronze: Raw ingested data
• Silver: Cleaned, validated, and transformed data
• Gold: Business-level data for analytics, dashboards, and reporting

• Group1 — security-enabled: Eligible.
• Group2 — mail-enabled and security-enabled: Eligible because it is still a security group.
• Group3 — Microsoft 365 group: Not eligible for group-based licensing.
• Group4 — Microsoft 365 group, not security-enabled: Not eligible.

• B. Versioned configuration files — Infrastructure is defined in machine-readable files and tracked in version control, allowing repeatable provisioning and change history.
• D. Docker files — Assuming “Doctor files” is a typo for Dockerfiles, a Dockerfile declaratively defines how to build a container image and is commonly considered infrastructure/configuration as code.

• A. Cloned virtual machine images — These are prebuilt infrastructure artifacts, but cloning an image is not itself a code-based infrastructure definition.
• C. Change management database records — A CMDB records information about infrastructure; it does not define or provision that infrastructure.

• Two-part tariff pricing: $10 per unit
• Dual pricing: $20 per unit

Two-part tariff pricing

Dual pricing

• Division X, the seller, is credited with the market price: \(\$20\)
• Division Y, the buyer, is charged the marginal cost: \(\$10\)

• 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.

• Deterministic approve/reject results
• Strict adherence to predefined rules
• Consistent, reproducible outcomes
• Auditability and regulatory compliance

• The ERSPAN source is the device or interface whose traffic is being copied.
• The ERSPAN destination is the device receiving the encapsulated copy and forwarding it to the traffic analyzer.
• The local monitor session number is locally significant. Therefore, the source and destination do not need matching session IDs such as 47 or 48.
• The erspan-id identifies the ERSPAN stream and must correspond between the source and destination configuration.

• Keep earlier prompt versions.
• Identify the last version that produced acceptable output.
• Restore it as a baseline.
• Make small, controlled changes—ideally one significant change at a time.
• Test the output after each change.

• A: Discards useful information about what worked.
• B: Large simultaneous changes make it difficult to identify the cause of problems.
• D: Accepts output that does not meet the requirements.

• Business risks
• Potential financial, operational, legal, or reputational impact
• How governance reduces risk to organizational objectives
• How much risk the organization is willing to accept

• Install unauthorized or unsupported software
• Access features blocked by the manufacturer or operating system
• Customize system behavior beyond normal settings

• Azure Cosmos DB is a globally distributed NoSQL database service. It stores and retrieves application data, but it does not provide the complete environment for building, testing, and deploying predictive analytics models.
• Azure Machine Learning is the appropriate service for this requirement. It supports creating experiments, training and testing models, and deploying them for predictions.
• Azure Machine Learning Studio provides the browser-based interface for these tasks.

• Regression predicts continuous numeric outcomes, such as house price, temperature, or sales amount.
• Linear regression assumes the target can be estimated from a linear relationship between the input features and the target.
• In Azure Machine Learning, you use a labeled dataset containing:

• Classification predicts a category or class, such as “spam” or “not spam.”
• Clustering groups similar records without a known label; it is an unsupervised learning technique.

• Sustainability
• Performance efficiency
• Reliability

• 10 TB with maximum I/O performance: Use EC2 instance store. It provides very high-throughput, low-latency local storage suitable for temporary video-processing data. The application must tolerate data loss because instance store is ephemeral.
• 300 TB of highly durable media: Use Amazon S3, which is designed for highly durable object storage and can scale to this size.
• 900 TB of inactive archival media: Use S3 Glacier, which provides lower-cost storage for data that is rarely accessed.

• A: Amazon EBS offers high performance but is not the best fit for the question’s “maximum possible I/O” requirement compared with local instance store.
• B: Amazon EFS is durable and shared, but is generally more expensive and less suitable for very large archival storage.
• C: Uses EC2 instance store for performance, but incorrectly uses EFS for the 300-TB durable tier and S3 rather than Glacier for archival data.

• A — Tables
• B — Named file formats
• C — Schemas
• E — Databases

Why these are correct

• Tables: Can be cloned using CREATE TABLE ... CLONE. The clone initially uses zero-copy cloning, so storage is shared until changes are made.
• Named file formats: Can be cloned as database objects, preserving the file-format definition.
• Schemas: A schema and its eligible objects can be cloned.
• Databases: A database and its eligible schemas and objects can be cloned.

Why the others are incorrect

• Shares: A share is an account-level data-sharing object, not a normal cloneable database object.
• Users: Users are security principals and cannot be cloned with CLONE.

• Set credit quotas for an account or individual virtual warehouses.
• Define monitoring intervals.
• Trigger actions when usage reaches thresholds, such as sending notifications or suspending a warehouse.
• Help control unexpected warehouse spending.

• Account Usage: Provides historical usage and billing data; it does not enforce credit limits.
• Warehouse Limit Parameter: Not the Snowflake object used for account-wide credit controls.
• Credit Consumption Tracker: Not a standard Snowflake object.

• transform() — modifies every element in an array
• filter() — keeps elements matching a condition
• exists() — checks whether any element matches
• aggregate() — reduces array elements to one result

sql 
SELECT transform(scores, x -> x * 2) 
FROM student_scores;

• A is incorrect because higher-order functions are mainly useful for nested or complex data.
• B is incorrect because they do not convert logic into Python.
• D is incorrect because their purpose is not to fix slow built-in functions, but to process arrays or maps with custom logic.

• 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.

1. Wireless AP

1. Router

1. Firewall

1. Device placement

• Link-local — FE80::/10; valid only on the local link/subnet and not routed by routers.
• Multicast — FF00::/8; identifies a group of interfaces rather than a private address range.
• Global unicast — 2000::/3; publicly routable IPv6 addressing.

• Configure row-level security (RLS) using the sales region and the HR manager’s identity.
• Publish the reports and datasets through a Power BI app.
• Grant the HR managers permission to use the app, but do not add them as workspace members.
• App users can view and interact with reports while RLS limits them to their region.
• They cannot modify the report layout because they do not have workspace editing permissions.

• Adding them to the workspace gives them workspace permissions that may allow report or dataset changes, depending on the assigned role.
• Creating copies is unnecessary and creates maintenance and security problems.
• Hosting datasets and reports in different workspaces does not, by itself, provide the required controlled access.

• Amazon S3 as the origin for static content
• Application Load Balancer (ALB) as the origin for dynamic content
• Amazon Route 53 configured to point the company’s domain name to CloudFront

• /static/* ? S3 origin; cache content at edge locations
• Dynamic paths such as /api/* ? ALB origin; forward requests to the EC2 application

• 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.

1. Wireless AP

1. Router

1. Firewall

1. Device placement

• Transport and handling
• Storage and warehousing
• Refrigeration
• Shelf-stacking or replenishment
• Other costs directly attributable to product P

• Each Azure VM must have at least one network interface (NIC).
• A single NIC can have:

• Therefore, each of the five VMs needs only one NIC:

• Plenum: Describes a fire-resistant cable jacket rating, not a transmission medium or speed.
• Ethernet: Describes a networking technology; Ethernet can use copper or fiber, so the term alone does not identify the fastest cable type.
• DAC (Direct Attach Copper): Uses copper and is typically intended for short-distance, high-speed connections in data centers.

• HTTPS: Secure web traffic, not general command-line server administration.
• SNMPv3: Secure network monitoring and management, not interactive server login.
• RDP: Provides graphical remote desktop access. It can be secure, but it is not the direct replacement for Telnet in this scenario.
• SMTP: Used to send email.

• Static IP address: Not needed if the workstation already has network connectivity.
• Subnet mask: Incorrect subnetting would usually prevent local communication, including pinging the server.
• Default gateway: Primarily affects communication outside the local network; it does not normally prevent finding an internal domain controller.

• 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.

• 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.

• C — Custom buttons display at the top and bottom of a page: Correct. In Salesforce Classic, buttons can appear in the page’s button areas, including the top and bottom of record pages.
• D — Custom buttons are available for Person Accounts: Correct. Person Accounts use the Account object, so Account custom buttons can be available on Person Account layouts.
• E — Custom buttons can reference an external app: Correct. A URL custom button can launch or navigate to an external application or website.

• A: JavaScript custom buttons are a Salesforce Classic feature and are not supported in Lightning Experience. They do not enhance Lightning Experience.
• B: The User object does not generally support custom buttons in the same way standard business objects do.

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

• Layer 4 firewall: Filters based mainly on IP addresses, ports, and connections; it lacks detailed web-request inspection.
• NGFW: Provides broader network security, but a WAF is more specialized for protecting web applications.
• UTM: Combines multiple security functions, but it is not necessarily optimized for web-application protection.

• 25 — Traditional SMTP server-to-server mail delivery; often restricted and not the usual client submission port.
• 110 — POP3, used for retrieving email; normally unencrypted.
• 143 — IMAP, used for retrieving and synchronizing email; normally unencrypted.

1. It examines the source MAC address and learns it on the incoming port.
2. It examines the destination MAC address.
3. If the destination MAC is already in the MAC/CAM table, it forwards the frame only through the associated port.
4. If the destination MAC is unknown, it performs unknown-unicast flooding:

• A. IDS attack signatures: An IDS primarily detects suspicious network activity; it is not the best tool for scanning uploaded files.
• C. Load balancer: Improves availability and distributes traffic but does not inspect files for malware.
• D. WAF: Protects web applications against attacks such as SQL injection and command injection. It may inspect HTTP requests, but malware scanning of uploaded PDFs is the key requirement here.

• Red team: Offensive security; attempts exploitation and simulates attackers.
• Blue team: Defensive security; monitors, detects, and responds to attacks.
• Purple team: Combines red- and blue-team activities to improve defenses, but is not the best direct answer here.
• White team: Usually oversees or coordinates an exercise, including rules of engagement and scope.

• Disable high concurrency: This changes session-sharing behavior but does not provide dedicated compute or true workload separation.
• Modify the number of executors: Adjusts resources within a Spark job; it does not isolate bronze and silver processes.
• Set the default environment: Controls libraries and runtime configuration, not compute isolation.