RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 2 )

• 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.

• A: Daily involvement is unnecessary and may not solve the availability problem.
• C: Clarifying all requirements at the start conflicts with agile’s iterative refinement.
• D: Simply reviewing based on availability leaves the problem unresolved and allows rework to continue.

• Permanent table (E): Correct. A dropped permanent table can be restored with UNDROP TABLE during its Time Travel retention period. Permanent tables also have Fail-safe protection.
• Transient table: It can also generally be restored during its shorter Time Travel period, although it has no Fail-safe. Therefore, excluding it makes the question questionable.
• Temporary table: Usually cannot be recovered after it is dropped; its lifecycle is limited to the session.
• Materialized view (D): The answer key treats it as recoverable, but recovery behavior depends on the specific Snowflake object/version capabilities. It should not be confused with an ordinary view.

• Answer: False. Agents and managers CAN create knowledge articles from Community questions.

• Why: In ServiceNow, a Community question can be converted into a Knowledge article using the Create Knowledge (or Convert to Knowledge) action. This allows what customers asked to become a reusable article for others.

• How it works (high level):

• Permissions: This ability depends on having the right roles/permissions (e.g., agents or knowledge managers). If you don’t see the option, check your role assignments or the knowledge-management configuration.

• Quick take: If a question in Community is valuable for others, a trained agent can turn it into a Knowledge article, making it available for self-service.

• Correct answer: C: Amazon Comprehend.

• Why: The library wants to classify books based on their text content. This is an NLP (natural language processing) task. Amazon Comprehend is AWS’s managed NLP service that can perform content classification (including creating custom classifiers) and extract meaningful information from text. The other services are not focused on text classification:

• Quick note: In practice, you’d store the books in S3, extract text if needed (e.g., from PDFs with Textract), and then use Comprehend to classify the documents into topics or genres.

• Replace the keyboard: More expensive and unnecessary before simpler causes are ruled out.
• Replace the key switch: Laptop keyboards generally aren’t designed for individual switch replacement.
• Replace the circuit board: Excessive for a single nonworking key and not a cost-effective first step.

• B — AWS DataSync: Transfers data between storage systems, such as S3, file systems, and on-premises storage. It is not a marketplace or catalog for third-party datasets.
• C — Kinesis Data Streams and CodeCommit: CodeCommit is a source-code repository, not a third-party data provider. Kinesis is for streaming data ingestion.
• D — Kinesis Data Streams and ECR: ECR stores container images, not datasets. Kinesis does not provide access to ECR data as an external dataset source.

• Reusing features across different models and teams
• Consistent feature definitions
• Managing feature versions and metadata
• Using features for both training and inference

• SageMaker Data Wrangler: Prepares and transforms data; it is not primarily a shared feature repository.
• SageMaker Clarify: Helps detect bias and explain model predictions.
• SageMaker Model Cards: Documents models, including intended use, risks, and evaluation results.

• vSmart controls the overlay control plane. It uses OMP to exchange routing information, distribute policies, and determine how WAN Edge devices reach one another.
• vManage is the centralized management and configuration platform.
• vBond is the orchestrator. It helps devices authenticate, discover controllers, and traverse NAT during onboarding.
• APIC-EM is not the SD-WAN control-plane component described here.

• Multiple AWS accounts: Create a separate account for each department or workload. This provides clear isolation and makes it easier to track each department’s usage and costs for chargeback.
• Consolidated billing: AWS Organizations can combine billing for multiple accounts into one central payer account. The company can still view costs by account while managing payment centrally.

• Placement groups: Control how EC2 instances are physically placed for networking or performance; they do not provide departmental billing separation.
• Edge locations: Infrastructure used by services such as Amazon CloudFront; unrelated to chargeback.
• AWS Config: Records and evaluates resource configurations and compliance; it is not a billing-separation mechanism.

Simple explanation

• The Azure VPN gateway to connect to
• Authentication settings
• Routes for networks that the client can access

1. Ensure BOMs can include subcomponents ? Configure an entity relationship

1. Report changes made by engineers ? Enable auditing

• Configure entity relationship
• Configure auditing

• Correct choices: A and D.

• Why not B, C, or E?

• R-squared (R²): mede quanto da variação dos valores reais é explicada pelo modelo. É mais usado em regressão, não em classificação.

• Accuracy (acurácia): mede a proporção de previsões corretas em relação ao total. É adequada para a classificação de imagens da questão.

• RMSE (Root Mean Squared Error): mede o tamanho médio dos erros entre valores previstos e reais, penalizando erros maiores. É usado principalmente em regressão.

• Learning rate (taxa de aprendizado): controla o tamanho dos ajustes feitos pelo modelo durante o treinamento. Não é uma métrica de avaliação; é um hiperparâmetro.

• Why: Table.Profile returns a per-column profile that includes statistics such as count, null count, distinct count, and standard deviation. It also provides min/max and average where applicable, which matches the requested metrics (Count, Average, Null count, Distinct count, Standard deviation).
• Syntax: Table.Profile(table as table, optional additionalAggregates as nullable list) as table
• How it helps: After running Table.Profile on your table, you can extract the per-column stats you need and display them in your semantic model or report.

• Cross-account access is typically implemented with an IAM role. You create a role in the target account (where the resources live) and configure a trust policy that allows principals from the source account to assume that role.
• Users in the source account then assume the role (via Switch Role in the console or STS:AssumeRole) and receive temporary credentials with the role’s permissions to access the resources.

• IAM group: Groups exist inside a single account; they don’t grant cross-account access.
• IAM tag: Tags are metadata and do not grant access.
• IAM Access Analyzer: It analyzes and identifies public or cross-account access but does not grant access itself.

• IaaS: You deploy and manage virtual machines, operating systems, disks, and networking. Azure manages the physical datacenter and host infrastructure.
• PaaS: Azure manages the operating system and runtime so you can focus on deploying applications, such as with Azure App Service or Azure Functions.
• SaaS: You consume a complete, provider-managed application.

• BCP: Maintains essential business operations during and after disruption. It is broader than IT recovery, but the question focuses on restoring the destroyed data center.
• Communication plan: Defines how the organization communicates with staff, the public, and other stakeholders.
• IRP: Handles security incidents such as malware, unauthorized access, or data breaches—not physical disaster recovery.

• Generates a syslog message
• Shuts down the PoE port
• Places the port into error-disabled (err-disabled) state
• Frees the power allocation

• A device starting to draw power does not necessarily generate a syslog message.
• Monitoring does not pause data traffic while checking power.
• Drawing less than the configured minimum does not automatically mean the device has failed and should be disconnected.

• Modelo de embeddings de texto: trabalha principalmente com texto, não sendo adequado para imagens.
• Modelo generativo multimodal: pode interpretar ou gerar conteúdo de vários tipos, mas não é a opção específica para busca por similaridade.
• Modelo de geração de imagens: cria imagens a partir de entradas, não realiza busca multimodal.

• The correct answer: B) Synthetic identity theft.

• Synthetic identity theft involves creating a new, forged identity by combining information from multiple real people (e.g., names, dates of birth, SSNs) to commit fraud.
• In the scenario, Adam “created a new identity by obtaining information from different victims,” which matches the idea of synthesizing data to form a fake person.

• Medical identity theft: using someone’s medical information to obtain care or services.
• Tax identity theft: using someone’s personal info to file fraudulent tax returns.
• Social identity theft: impersonating someone to deceive others socially or publicly.

• Look for phrases like “create a new identity” or “combine information from multiple people” to identify synthetic identity theft.

1. Ingestion Lambda receives requests from API Gateway and places messages in an SQS queue.
2. Processing Lambda is triggered by the queue and loads records into Aurora PostgreSQL.

• Decoupling: API request handling is separated from database loading.
• Buffering: SQS absorbs bursts when incoming traffic exceeds the database’s processing capacity.
• Controlled concurrency: Configure the SQS-triggered Lambda’s concurrency and batch size to avoid overwhelming Aurora or exhausting database connections.
• Automatic retries: Messages that fail processing can return to the queue and be retried. A dead-letter queue can capture persistent failures.
• Lower operational effort: The solution remains serverless and avoids managing EC2 servers or Kubernetes clusters.

• A: EC2 and Tomcat add server-management overhead.
• B: DynamoDB/DAX would require changing the database model and does not solve the Aurora ingestion design.
• C: SNS is useful for notifications and fanout, but SQS is better for durable buffering and backpressure in this producer-consumer workflow.

• Drop violating frames
• Log or alert on the violation
• Shut down or restrict the port

• Load balancer: Distributes application traffic; it does not control switch MAC learning.
• IPS: May detect some network attacks but is not the primary control for switch MAC-table exhaustion.
• NGFW: Protects traffic crossing network boundaries, while MAC flooding occurs at the switching/LAN layer.

• Writing with Apache Spark, typically as Delta tables.
• Reading with Apache Spark for processing and analysis.
• Reading with T-SQL through the lakehouse’s automatically generated SQL analytics endpoint.
• Reading with KQL through Fabric’s query capabilities that can access lakehouse data.

• Eventhouse: Optimized for real-time and KQL workloads, but it is not the natural destination for Spark-based writes or general lakehouse storage.
• Datamart: Intended mainly for relational analytics and Power BI; it is not designed for Spark-based data ingestion.
• Warehouse: Primarily T-SQL-based and structured. It does not provide the same native Spark write experience or flexibility for semi-structured data.

• Options:

• Answer: The correct choice is A (800-61r3).

• NIST SP 800-61 Rev. 3 is the dedicated guide for incident handling/response and reflects the latest guidance on the incident response lifecycle (preparation, detection/analysis, containment, eradication, recovery, post-incident activity).
• 800-61r2 is an older revision of the same incident response guide.
• 800-53 covers security and privacy controls, not a specific incident response standard.
• 800-171 focuses on protecting CUI in non-federal systems and networks, not incident response guidance.

• A recipient who already has a Microsoft account or an organizational account can authenticate by signing in.
• A recipient without a usable Microsoft identity may receive a one-time passcode by email.
• The passcode is sent to the same email address that was invited and is used to verify ownership of that address.

• A limited lifetime
• Permissions defined by an IAM role or policy
• The ability to access AWS APIs without using long-term IAM user credentials

• Amazon API Gateway — Builds and manages APIs; it does not generally issue AWS credentials for applications.
• IAM users — Usually use long-term credentials, which are less suitable for applications.
• IAM instance profiles — Provide temporary role credentials to applications running on EC2 instances, but are specifically tied to EC2. The broader requirement described is best met by AWS STS.

• Workspace: Stores notebooks, libraries, jobs, and other project resources.
• Notebooks: Interactive documents containing code, queries, visualizations, and explanations. Common languages include Python, SQL, Scala, and R.
• Clusters: Groups of virtual machines that run Spark workloads. Clusters can be started, stopped, and automatically scaled.
• Data access: Databricks can read from services such as Azure Data Lake Storage, Azure Blob Storage, and Azure SQL.
• Jobs: Automate notebooks or data-processing workflows on a schedule or in response to events.

• Date: 2018-12-31
• Time: 08:59

• B: The original value contains the text at, so it cannot be converted directly to a date.
• A: The last characters contain the time, not the date.
• D: Extracting the first 11 characters can leave an unwanted space and does not properly separate the time component.

• Ablauf: Er wird in der gleichen Transaktion ausgeführt, bei der z. B. ein Datensatz erstellt oder aktualisiert wird. Der Benutzer wartet, bis der Workflow abgeschlossen ist.
• Stufen: Kann vor dem Vorgang (pre-operation) oder nach dem Vorgang (post-operation) laufen.
• Zweck: Sofortige Validierung oder Anpassung von Daten, ggf. auch das Verhindern eines Vorgangs, wenn Bedingungen nicht erfüllt sind.

• Automatisierte Flows (Power Automate, automatisierte/ Background Flows) laufen asynchron im Hintergrund, nachdem der Trigger erkannt wurde, und blockieren den Benutzer nicht.

• A — VARIANT "null" values are not the same as SQL NULL: Correct.

• B — Frequent, single-row DMLs: Incorrect.

• C — Validate data before loading into the target table: Correct.

• D — Use staging tables to manage MERGE statements: Correct.

• Correct answer: D – Do not enable default administrative accounts to ensure accountability.

• A – Do not use encryption methods … backups and sensitive information: Encryption helps protect data; not using it increases risk, not reduces insider threats.
• B – Do not allow administrators to use unique accounts during installation: We actually want unique admin accounts, not the opposite.
• C – Do not control the access to administrators and privileged users: Failing to control access directly enables misuse.

• Mesh: WAPs communicate wirelessly with one another, often to extend coverage without wired connections. It does not specifically describe centralized WLC management.
• Point-to-point: Connects two specific devices or locations.
• Ad hoc: Wireless devices communicate directly with one another without an access point.

• Business
• People
• Governance
• Platform
• Security
• Operations

• Cloud financial management
• Portfolio and program management
• Risk management
• Data governance
• Compliance and oversight

• Startup scripts run at computer startup, before any user logs on, making them ideal for machine-wide configuration on each new VM.
• They execute under the Local System account, which is appropriate for initial setup tasks.
• Linking a GPO to the OU ensures every new VM in that domain automatically receives the configuration—great for scalability.

• A) SetupComplete.cmd runs only once, right after Windows Setup, not on every boot, so it isn’t ideal for provisioning multiple VMs consistently.
• B) Logon scripts run per user, not per machine, so they aren’t reliable for initial VM configuration before a user signs in.
• D) Placing scripts in a VHD doesn’t automatically execute them.

• The correct answer is A: CCTV recordings are not regularly reviewed.

• CCTV is a monitoring/control mechanism. If recordings aren’t reviewed, security events (break-ins, policy violations, equipment tampering) can go undetected and unaddressed.
• Regular review is essential for deterrence, incident response, and forensic evidence. Without it, the entire CCTV control provides little value.

• B (records deleted after one year) affects forensic availability, but it’s a data-retention issue rather than the ongoing effectiveness of the surveillance program.
• C (footage not recorded 24x7) creates gaps in coverage, which is a concern, but regular review of available footage still supports detection; 24x7 coverage is a separate policy/perimeter issue.
• D (cameras not in break rooms) is more about privacy and space planning than core data-center security monitoring.

sql 
GRANT ALTER ON SCHEMA::schemaA TO User1;

• TRUNCATE TABLE is a DDL operation, not a normal DELETE.
• Having DELETE permission on a table is not sufficient to truncate it.
• The minimum relevant permission is ALTER on the table.
• Granting ALTER on SCHEMA::schemaA allows the user to truncate tables within schemaA.
• It does not grant equivalent permissions on schemaB or schemaC, satisfying least privilege.

• Azure Cosmos DB is a globally distributed NoSQL database service. It stores and retrieves application data, but it does not provide the tools needed to build, test, and deploy predictive analytics models.
• Azure Machine Learning—including the historical Azure Machine Learning Studio—is designed for the machine-learning lifecycle:

• Context: You’re configuring a Windows Autopilot deployment profile (Profile1) for Windows 11 devices. The hotspot asks you to pick the correct behavior for two statements based on the profile’s settings.

• Box 1: “can modify the desktop settings only for themselves”

• Box 2: “Cortana settings” with options like computer name, keyboard layout, etc.

• A. Implement retries with exponential backoff

• C. Reduce the frequency and/or size of requests

• B. Use PutRecord instead of PutRecords — PutRecord sends one record per call and does not remove the underlying throughput limitation. It may increase request overhead.
• D. Use Amazon SNS instead — SNS is not a direct fix for Kinesis shard throttling and changes the required streaming architecture.
• E. Reduce KCL consumers — KCL consumers read from Kinesis; they do not solve producer-side PutRecords throttling.

• Failed login attempts
• The account being targeted
• The source user or system
• Time and frequency of attempts

• Two-factor authentication: Helps prevent unauthorized access, but does not primarily detect the employee’s attempts.
• Firewall: Controls network traffic; it generally does not monitor individual login attempts.
• Intrusion prevention system (IPS): Can detect certain network attacks, but this scenario is best addressed through authentication and audit logging.

• The problem: Guest users can’t create posts in the Monthly Reports channel.
• The recommended fix (answer B): Modify the Guest access settings in the Teams admin center.

• Guest access settings control what guests are allowed to do across Teams (for example, posting, chat, and channel participation). If guests are restricted from posting, enabling the appropriate guest permissions will let them post in channels like Monthly Reports.
• The other options don’t directly change guest permissions in the way that affects posting:

• The VPN gateway is in VirtualNetworkA.
• Gateway transit is configured on the peering associated with the VNet that contains the gateway—here, VirtualNetworkA.
• A peered VNet may use the remote gateway through the appropriate peering option, but this does not automatically update an existing P2S client’s routes.
• The Windows 10 workstation’s P2S VPN client package was created before VirtualNetworkB was peered, so it may not have a route for VirtualNetworkB.

• Customers access the portal without needing a full Dynamics 365 license.
• They submit case information through portal forms.
• The submitted data is stored in Dataverse tables, such as the Case table.
• Security is controlled using web roles and table permissions, so customers can access only appropriate records.

• Dynamics 365 Connector — connects apps to Dynamics 365 data but is not the portal’s underlying data platform.
• Microsoft SharePoint — useful for documents and collaboration, not the standard case-management data source for portals.
• Microsoft Azure Storage — stores files or other data, but is not the native portal business-data platform.

• Honeypots: Decoy systems or services designed to attract attackers. Legitimate users should not access them, so activity on a honeypot is a strong indicator of unauthorized activity. Security teams can also observe attacker behavior.

• DNS sinkhole: Redirects requests for known malicious domains to a controlled internal server or blocks them. If an infected workstation attempts to contact command-and-control infrastructure, the sinkhole records the request and helps identify the compromised device.

• Tokenization: Protects sensitive data by replacing it with tokens.
• CI/CD: Automates software development and deployment.
• Threat modeling: Identifies potential risks before or during system design.
• Data obfuscation: Makes data harder to understand, but does not detect intruders.

• A — conformant: Incorrect because one explicit requirement is violated.
• B — consistent: “Consistent” is not sufficient where the implementation contradicts a mandatory specification. The RPC mechanism is covered by the architecture, and the implementation differs from it.
• C — consistent: Incorrect reasoning: the RPC mechanism does have a defined architectural requirement, so conformance must be assessed.
• D — non-conformant: Correct because the implementation fails to follow the specified RPC/threading requirement.

• Why: ADS is designed to collect information about on-premises environments to plan migrations. It inventories details like hostname, IP address, MAC address, OS, hardware, and installed software, plus dependency mappings. This data helps you understand your current environment before moving to AWS.

• How it differs from the other options:

• Practical use: Install the ADS agent on on-prem hosts to collect data, then view the inventory in Migration Hub to inform migration planning and sequencing.

• IaaS provides virtualized infrastructure, including VMs, disks, and networking. You manage the guest operating system and software installed on the VM.
• PaaS provides a managed platform for deploying applications without managing the underlying VMs or operating systems. Examples include Azure App Service and Azure Functions.

• A. IDS attack signatures: An IDS primarily detects suspicious network activity and usually alerts rather than directly scanning and blocking uploaded files.
• C. Load balancer: Distributes traffic among servers but does not inspect files for malware.
• D. WAF: Protects web applications from attacks such as SQL injection, cross-site scripting, and some malicious requests. It is not primarily a PDF-malware scanning solution.