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.

• 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.

• Authentication — verifies who the user is.
• Authorization — determines what the authenticated user is allowed to access.
• Accounting — records session activity, such as login time and resource usage.

• CIA — confidentiality, integrity, and availability; core security objectives.
• ACL — access control list; rules that permit or deny traffic or access.
• PEM — Privacy Enhanced Mail, an older email security standard.

• A: It allows for branching and merging...

• C: It allows multiple engineers to work against the same code and configuration files and manage differences and conflicts.

• B: Build automation and infrastructure provisioning are handled by CI/CD and automation tools, not by version control alone.
• D: User Stories and backlogs are managed by project-management tools.
• E: Version control stores and tracks code, but it does not itself ensure that developers write effective unit tests.

• User preferences change, so the model must learn from recent data.
• Keeping the existing data helps preserve knowledge of older patterns and provides a broader training distribution.
• Training only on new data can cause catastrophic forgetting and may overfit if the new dataset is small.
• The new data should not automatically be used as the test set, because it is needed for training and the model must still be evaluated on separate, representative data.

• vBond — orchestration plane: Authenticates devices, helps them discover each other, and assists with NAT traversal and initial control-connection setup.
• vSmart — control plane: Distributes routing and policy information to WAN Edge devices using the overlay control plane.
• vManage — management plane: Provides centralized configuration, monitoring, and orchestration through its GUI/API.
• WAN Edge — data plane: Forwards user traffic across the SD-WAN fabric.

• Identified risks
• Risk owners or responsible parties
• Likelihood and impact
• Risk response plans
• Current status
• Risk thresholds or trigger conditions

• Risk tolerance: The amount and type of risk an organization is willing to accept; it is not primarily a tracking document.
• Risk transfer: Moving the financial or operational impact of a risk to another party, such as through insurance or outsourcing.
• Risk analysis: The process of evaluating a risk’s likelihood and impact.

• CCTV system — Detective control: Cameras monitor and record activity, helping identify or investigate security incidents after—or while—they occur.
• Signs about being filmed — Deterrent control: The signs discourage people from attempting unauthorized or criminal activity because they know surveillance is present.

• Preventive: Stops an incident from occurring, such as a lock or access-control system.
• Corrective: Restores systems after an incident.
• Directive: Instructs people to behave in a certain way, such as a security policy.
• Compensating: Provides an alternative control when the preferred control cannot be implemented.

• Microsoft Teams: Connects to Teams-related data, but it isn’t the primary connector for the Power Apps data tables.
• Personal Analytics: Provides personal productivity insights, not application data.
• SQL Server database: Only applies if the app explicitly uses SQL Server as its data source.
• Dataflows: Used for preparing and centralizing data, not as the normal direct connection to a Power Apps app.

• Reviewing security objectives to ensure they support business goals.
• Ensuring security requirements are integrated consistently across business units.
• Coordinating security policies, risk management, controls, and awareness activities.

• Executive management: Provides direction, funding, and support, but usually does not manage day-to-day security integration.
• Board of directors: Provides governance and oversight, not operational security coordination.
• Steering committee: Helps coordinate and prioritize initiatives, but the CISO typically owns the overall security program and ensures its integration.

• Confirm the required columns and data types
• Identify the target/label column
• Handle missing or duplicate records if present
• Transform data into a suitable format
• Split it into training and validation/test datasets

1. Prepare the training data
2. Select an algorithm or configure AutoML
3. Train the model
4. Evaluate its performance
5. Tune hyperparameters if needed
6. Deploy the model

• Transfer — przeniesienie skutków lub kosztów ryzyka na inna organizacje, np. przez ubezpieczenie lub umowe.
• Akceptacja — firma swiadomie przyjmuje ryzyko bez dodatkowych dzialan.
• Mitigacja — zmniejszenie prawdopodobienstwa wystapienia ryzyka lub jego wplywu, np. przez wdrozenie kontroli bezpieczenstwa.
• Unikanie — calkowite wyeliminowanie ryzykownej dzialalnosci.

• Advanced Persistent Threat (APT): A sustained, targeted attack campaign or attacker group—not a vulnerability.
• Trojan: Malware disguised as legitimate software.
• Stealthware: A general term for malware designed to avoid detection; it does not specifically mean an unknown vulnerability.

• Microservices: An application-design approach that divides an application into smaller services. It does not inherently reduce the number of operating systems.
• Virtualization: Creates virtual machines, but each VM generally requires its own complete operating system. This improves isolation but does not minimize OS instances as effectively.
• Infrastructure as code: Uses code to automate infrastructure deployment and configuration. It improves consistency but does not determine how many operating systems are used.

json 
{ 
  "Effect": "Deny", 
  "NotAction": [ 
    "iam:*", 
    "route53:*", 
    "cloudfront:*", 
    "support:*" 
  ], 
  "Resource": "*", 
  "Condition": { 
    "StringNotEquals": { 
      "aws:RequestedRegion": "eu-west-1" 
    } 
  } 
}

• SCPs set maximum permissions; they do not grant permissions. The default SCP allows actions, so the restriction must be an explicit Deny.
• aws:RequestedRegion checks the Region targeted by an API request.
• StringNotEquals: eu-west-1 denies requests directed to every other Region.
• NotAction allows designated global services to remain usable because they do not operate in a single AWS Region.
• Attaching the SCP to the OU makes it apply to existing accounts and accounts later added to that OU.

• Tactics: The attacker’s overall goal, such as gaining persistence or exfiltrating data
• Techniques: The methods used to achieve that goal
• Procedures: The specific implementation or sequence of actions

• IP addresses and hash values: Useful indicators, but they can change quickly.
• Indicators of compromise: TTPs may help identify IOCs, but their main value is describing behavior.
• Tools: Attackers can replace tools or use legitimate administrative utilities.

• Secret scope: A named container that groups related secrets and defines access permissions. Example: finance-prod.
• Secret key: The name of an individual secret stored inside that scope. Example: db-password.

text 
Scope: finance-prod 
  Key: db-username 
  Key: db-password

python 
dbutils.secrets.get( 
    scope="finance-prod", 
    key="db-password" 
)

• C — Some risks cannot be eliminated.

• D — Accepting residual risk does not imply recklessness.

• E — Most companies in this industry will say something similar.

• Limiting the number of MAC addresses allowed on a switch port
• Restricting ports to specific known MAC addresses
• Taking an action—such as dropping frames or shutting down the port—when the limit is exceeded

• Load balancer: Distributes application traffic; it does not protect switch MAC tables.
• IPS: May detect some attack traffic, but is not the primary control for switch-port MAC limits.
• NGFW: Filters network traffic at the firewall, but does not directly control MAC addresses learned by a switch.

• The S3 bucket as an origin for static content
• The Application Load Balancer (ALB) as an origin for dynamic content
• An Amazon Route 53 alias record pointing the application domain to CloudFront

Why this works

• Static data: CloudFront caches objects from S3 at edge locations, reducing latency for users worldwide.
• Dynamic data: CloudFront forwards requests that require application processing to the ALB. It can also maintain persistent connections and use the AWS global edge network to improve delivery performance.
• One domain: CloudFront behaviors can route different path patterns to different origins—for example, /static/* to S3 and other paths to the ALB.

Why the other options are incorrect

• Global Accelerator is designed primarily for accelerating traffic to applications with endpoints such as ALBs, not for caching S3 content.
• Using separate domains or splitting static and dynamic traffic adds unnecessary complexity.
• CloudFront already provides the required global edge distribution and caching, so combining it with Global Accelerator is unnecessary here.

• Crash cart: Provides local physical access, not remote access.
• Jump box: A secured intermediary used to reach devices over the normal network; it may be inaccessible if the appliance has not booted.
• Secure Shell (SSH): Requires the device’s operating system and network services to be running properly.

• 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.

• Separate accounts/domains create a strong administrative boundary between non-production and production.
• Separate projects provide distinct IAM boundaries, billing, quotas, service accounts, and resources.
• Developers can receive permissions in the development project without automatically gaining access to production.
• Production administrators can be restricted from development resources, supporting separation of duties and least privilege.

• A: Creates excessive project fragmentation without being required by the stated requirement.
• C: Keeps development and production under one account and does not clearly separate administrative duties.
• D: Uses one account and only two projects; it provides some project isolation but weaker organizational separation.

• A: My Domain is required for many SSO configurations, but if SSO works, it is unlikely to be the cause of losing the target record.
• B: HTTP-POST is a valid SAML binding and does not inherently prevent redirection.
• D: An incorrect Federation ID generally causes authentication or user-matching failure—not successful login to the home page.

• BIOS language support: Useful for usability, but not whether the PC can operate electrically.
• Supply chain security: Concerns procurement and hardware trust, not deployment across countries.
• Power efficiency: Important for energy usage, but it does not ensure compatibility with local power systems.

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

• A: Allow SAN certificates — SANs are used to identify valid hostnames in a certificate. They do not bypass trust validation.
• C: Open the secure LDAP port — A blocked port would normally cause a timeout or connection-refused error, not certificate errors.
• D: Increase the TLS version on the RA — The issue concerns certificate trust, not the organization’s registration authority.

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

• Authentication: Verifies a user’s identity, such as username and password.
• Authorization: Determines what the authenticated user is allowed to access.
• Accounting: Records connection and usage details, such as login time or session duration.

• CIA: Confidentiality, integrity, and availability are broad security objectives, not a specific RADIUS function.
• ACL: An access control list contains permit/deny rules on systems or network devices. RADIUS can support access decisions but is not itself an ACL.
• PEM: Privacy-Enhanced Mail is also associated with certificate and key encoding formats; it is unrelated to RADIUS’s primary purpose.

• Users logging in more frequently than average
• Logins occurring during non-business hours
• Patterns that may indicate compromised credentials or suspicious access

• Login History: Shows individual login attempts and basic details, but does not provide behavioral analysis or averages.
• Login Inspector: Used to troubleshoot or inspect a specific login attempt, rather than analyze organization-wide patterns.
• Login Report: May provide reportable login information, but it is not the specialized tool for forensic behavioral analysis.

• Compensating control: The server is end-of-life, so it may no longer receive security patches or support. Placing it on a restricted VLAN provides an alternative layer of protection by reducing who can access it and limiting its exposure.
• Technical control: VLAN segmentation and access control lists (ACLs) are technology-based mechanisms that enforce network access restrictions automatically.

• Managerial: Policies, procedures, and governance—not network configuration.
• Physical: Locks, guards, or barriers.
• Corrective: Restores systems after an incident.
• Detective: Identifies suspicious activity rather than restricting access.
• Deterrent: Discourages behavior but does not enforce access rules.

• Azure Resource Manager (ARM) templates
• Or, in newer Azure terminology, Bicep files

• A. Microsoft 365 group with Assigned membership
• C. Microsoft 365 group with Dynamic User membership

Why?

• Assigned membership: You explicitly add User1, User2, and User3.
• Dynamic User membership: Membership is automatically determined by a rule based on user attributes.

Why the other options are incorrect

• B and D: Security groups do not support the Microsoft 365 group expiration policy.
• E: Dynamic Device groups are intended for devices, not these users, and are also security groups.

• Identifying the communication strategy: Usually part of a business continuity or incident response plan.
• Evaluating the risk management plan: Part of risk assessment and risk management activities.
• Establishing backup and recovery procedures: Usually part of disaster recovery planning.
• Developing the incident response plan: Part of incident response planning.

• Un AG puede tener réplicas en Windows y Linux desde SQL Server 2017; por tanto, una réplica Windows y otra Linux es posible.
• Sin embargo, las réplicas de un AG deben utilizar normalmente la misma versión principal de SQL Server. Una instancia SQL Server 2017 no puede tener directamente una réplica secundaria SQL Server 2019 como configuración normal y permanente.
• En tu escenario, SQL Server 2017 en Windows y SQL Server 2019 en Linux no se pueden añadir directamente como réplicas equivalentes de AG1. Primero habría que realizar un proceso de actualización/migración compatible, por ejemplo mediante una actualización gradual o una tecnología de migración como log shipping o distributed availability groups, según el diseño.

• Tipo de clúster y mecanismo de quorum.
• Failover normalmente manual en configuraciones multiplataforma.
• Edición y características compatibles.
• Configuración de endpoints y permisos.
• Limitaciones específicas de SQL Server en Linux.

• Documented and formally requested
• Analyzed for security, cost, and operational impact
• Reviewed and approved by the appropriate personnel
• Tested before implementation
• Tracked and reversible if problems occur

• Risk management process: Identifies and evaluates risk, but does not directly authorize design changes.
• Product design process: Applies primarily while creating or developing the product.
• Design review process: May have identified the issues, but the next step for changing an already released design is controlled change management.

• Additional running costs: $800
• Less depreciation: $300

• The $100 reduction in fixed production overhead absorbed is only an accounting reallocation. It does not represent an actual saving in total fixed overhead.

• Create a CodeCommit repository in the secondary Region.
• Use CodeBuild to run a Git mirror operation from the primary repository to the secondary repository.
• Use EventBridge to detect relevant repository events, such as a pull request being merged.
• Invoke a Lambda function, which starts the CodeBuild project.

• B: Amazon S3 is object storage, not a Git repository that developers can use as a CodeCommit remote.
• C: CodeArtifact is intended for packages and artifacts, not source-code repository mirroring.
• D: An AWS Cloud9 environment is not an appropriate automated replication mechanism and would require manual or persistent infrastructure management.

• Disaster recovery backups
• Long-term backup retention
• Data archiving that still needs occasional access

• Multi-Regional Storage: Intended for frequently accessed data needing broad geographic availability; it costs more.
• Regional Storage: Suitable for frequently accessed data within one region.
• Nearline Storage: Intended for data accessed roughly once per month, such as monthly backups.
• Coldline Storage: Better fit for backups accessed only during a disaster or occasional recovery event.

• A vulnerability scanner automates discovery of known vulnerabilities and misconfigurations across systems. It can contribute to a supply-chain assessment.
• A penetration test actively attempts exploitation and is usually limited to an agreed scope.
• SCAP standardizes vulnerability and configuration assessment data; it is not the analysis itself.
• Illumination tool is not a commonly defined CompTIA Security+ term.

• Server provisioning
• Operating systems and runtime infrastructure
• Scaling
• Much of the maintenance and patching

• Thin clients reduce endpoint hardware requirements but do not specifically streamline code deployment.
• Private cloud provides dedicated cloud infrastructure but usually requires more management and expense.
• Virtual machines improve resource utilization, but administrators still manage the VMs, operating systems, and deployments.

• Continuous deployment: Automates software releases; it does not specifically test input handling.
• Static code analysis: Examines source or compiled code without executing it. It can find coding flaws but does not directly stress the application with malformed inputs.
• Manual peer review: Developers inspect code or design manually. Useful, but not the best practice specifically for testing how a live product handles invalid input.

• Reviewing security policies and standards checks whether controls are documented, not whether they work.
• Reviewing security logs may show that monitoring is occurring, but does not directly establish that preventive controls are effective.
• Analyzing technical security practices is broad and may assess implementation, but it is less objective than an actual controlled attack.

• Design/compliance effectiveness: policies, standards, and procedures
• Operational effectiveness: logs, records, and evidence that controls operate
• Technical security effectiveness: penetration testing or vulnerability testing

1. Find the subnet-mask increment in the octet where the prefix ends.
2. Identify the network address by finding the subnet boundary at or below the given IP.
3. The first usable address is network address + 1.
4. The broadcast address is one address before the next subnet.
5. The last usable address is broadcast - 1.

• 172.28.228.144/18

• 172.28.228.144/23

• Financial performance
• Customer perspective
• Internal business processes
• Learning and growth

• Increasing the number of indicators can make the scorecard cluttered and less useful. Measures should be limited to those that are strategically important.
• The scorecard is mainly a tool for implementing and monitoring strategy, not for formulating strategy.
• It should contain both leading indicators and lagging indicators. Leading indicators predict future performance, while lagging indicators measure results already achieved.

1. Define Power Platform DLP policies

1. Add custom prompt modifications

1. Conduct adversarial testing

• Data Category Groups e categorias;
• Visibilidade dessas categorias para perfis ou permission sets.

• B e C: regras de compartilhamento não são o mecanismo apropriado para restringir resultados de busca do Knowledge por divisão.
• D: a role hierarchy não é o mecanismo principal para controlar a visibilidade de categorias do Knowledge. Além disso, a configuração correta é atribuir visibilidade a perfis ou permission sets.

• Inherent risk: Risk that exists before controls are implemented.
• Avoided risk: Risk eliminated by choosing not to perform the risky activity.
• Operational risk: Risk arising from failures in processes, people, systems, or daily operations.

• Honeypots: Deliberately vulnerable or attractive systems designed to lure attackers. Legitimate users should not access them, so activity on a honeypot is a strong indicator of compromise.
• DNS sinkholes: Redirect requests for known malicious domains to a controlled internal system instead of allowing the connection. This can identify infected hosts attempting to contact command-and-control infrastructure.

• Tokenization: Replaces sensitive data with non-sensitive tokens; it protects data but does not primarily detect attackers.
• CI/CD: Automates software development and deployment processes.
• Threat modeling: Identifies potential threats and weaknesses before or during system design.
• Data obfuscation: Makes data harder to understand, but it is not an attacker-detection method.

• 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.