RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 3 )

• 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.

• Due diligence: Researching and evaluating a third party before entering or continuing a business relationship.
• Internal audit: Evaluates controls within the organization itself.
• Penetration testing: Actively tests systems for exploitable vulnerabilities.
• Attestation: A formal statement or report—such as a SOC 2 report—provided by an independent party about an organization’s controls.

• Disable default accounts: Default or unused accounts may have known usernames or predictable settings, making them targets. They should be disabled, removed, or securely configured.
• Remove unnecessary services: Every running service creates potential vulnerabilities. Removing services the server does not need reduces exploitable entry points.

• Add the server to the asset inventory: Important for asset management, but not a hardening step.
• Document default passwords: Default passwords should be changed or eliminated—not documented for continued use.
• Send server logs to the SIEM: Valuable for monitoring and detection, but generally performed as part of logging/monitoring configuration.
• Join the server to the corporate domain: May be necessary operationally, but does not itself harden the server.

• Blue team: Defends systems, monitors activity, and responds to attacks.
• Purple team: Coordinates red- and blue-team activities to improve defenses.
• White team: Oversees or manages the exercise, including rules and scope.

• Training data for potential bias before model training
• Trained models for bias in predictions
• Model features to help explain how they influence predictions

• A: RAG workflows are typically built using services such as Amazon Bedrock, knowledge bases, and data sources.
• B: Monitoring model quality in production is primarily associated with SageMaker Model Monitor.
• C: Documenting model details is handled by capabilities such as SageMaker Model Cards.

• Distinct values = 69

• Unique values = 4

• Amazon EC2 instances — ???????? ?? ?? ??????? CPU, memory ??? instance size ???????? ???????
• AWS Lambda functions — memory configuration ?????????? ???????
• Amazon EBS volumes — volume type ?? size optimize ???? ???????
• ??????? ECS workloads — resource configuration ? cost optimization-?? ???????

• Memory ? compute usage ?????????? ???? custom code ????? ???? development ? maintenance ??????
• Cost allocation tags ???? ????? ??? ?????? ???? ??????? ???; inefficient resource ??????? ?? recommendation ???? ???
• CloudTrail resource ???? ?? API activity ??????, resource utilization ????

• The Intune device limit restriction does not apply in the normal way; DEM enrollment supports up to 1,000 devices.
• However, the Microsoft Entra maximum number of devices per user setting can still impose a limit when the enrollment creates an Entra device object.
• Therefore, a DEM account is not automatically unlimited. The effective limit depends on the Entra device setting and the enrollment/join type.

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

• The message came from the claimed sender (authentication)
• The message was not altered (integrity)
• The sender cannot easily deny sending it (non-repudiation)

• Attackers can send unsigned phishing emails.
• Attackers may compromise a legitimate account and send signed malicious emails.
• Users may still be tricked by a validly signed message.

• Tokens: Individual units of text processed by a model, such as words, subwords, or characters.
• Models: Systems that learn patterns and generate predictions or outputs.
• Binaries: Data represented using the binary number system, not semantic representations.

• 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.

• 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.

1. Clear principles and boundaries — Employees have freedom, but decisions must remain within clear organizational values, policies and limits.
2. High degree of freedom — Managers are trusted to make decisions rather than seeking continual approval from senior management.
3. Frontline customer responsibility — Customer-facing managers should be empowered to manage customer relationships and respond quickly to needs.
4. Transparent and ethical information — Information should be openly available and used honestly, supporting trust and informed decision-making.

• Share files with the wrong people
• Use public links unnecessarily
• Fail to classify sensitive data
• Upload data to unauthorized services
• Misunderstand company sharing policies

• A — Step-up authentication: Helps protect administrator accounts, but does not directly address improper file sharing by users.
• C — Password complexity: Helps reduce password attacks, not accidental data disclosure.
• D — Mobile device management: Secures managed mobile devices, but does not directly control file-sharing behavior across the organization.

• Owner, Contributor, and Network Contributor provide sufficient management permissions.
• Reader can view Traffic Analytics data but cannot enable or configure it.

• 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.

• Filtering harmful or inappropriate content
• Blocking specified topics
• Detecting and masking sensitive information
• Enforcing content policies suitable for children

• Amazon Rekognition analyzes images and videos; it does not control text generated by a language model.
• Amazon Bedrock playgrounds are for testing models and prompts, not enforcing production safety policies.
• Agents for Amazon Bedrock help models complete tasks and use tools; they do not primarily provide content-safety controls.

• Create the field in the CRM on the relevant person records—typically Lead and Contact in Salesforce.
• Give the Marketo Sync User read/write access to the field.

• C — Some risks cannot be eliminated.

• D — Accepting residual risk does not imply recklessness.

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

1. The specific table — for example, incident
2. The parent table — for example, task
3. The wildcard table — *, which applies broadly

• # Development
• # Testing
• # Production

• Separate endpoints: relate to compute or connectivity, not dashboard labels.
• Separate queries: retrieve or transform data but do not designate visual sections.
• Direct text written into the dashboard in editing mode: dashboards use text boxes, typically with Markdown formatting, rather than arbitrary text placed directly on the canvas.

• Liability accounts (2000–2999) would incorrectly require dimensions, although they should have none.
• Expense accounts (6000–6998) would incorrectly require Customer, which should be optional.
• Account 6999 needs a separate rule because it requires all four dimensions, including Customer.

• 2000–2999: no dimensions
• 4000–4999: Department and Division required; Project and Customer optional
• 6000–6998: Department, Division, and Project required; Customer optional
• 6999: Department, Division, Project, and Customer required

• Active-active routers: Provide redundant Internet connections/devices. Both can operate, so traffic can fail over or be load-balanced.
• Active-active firewalls: Avoid a single firewall becoming a failure point while maintaining security inspection.
• Load balancers: Distribute requests across multiple web servers. If one server fails, traffic can go to the other.
• Redundant power supplies: A server with separate power supplies should connect to independent power sources or circuits.
• UPS A and UPS B: Provide backup power and redundancy. Ideally, each power supply is connected to a different UPS.
• SONET ring: A ring topology provides alternate paths if a fiber link or segment fails.

• IaaS: You deploy and manage virtual machines, including the operating system and installed software. Azure manages the physical datacenter, hosts, and networking infrastructure.
• PaaS: Azure manages the infrastructure and operating system, while you deploy and manage your application code. Examples include Azure App Service and Azure Functions.

• 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.

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

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

1. Wireless AP

1. Router

1. Firewall

1. Device placement

CIMA P3 topics

• IT governance and systems strategy
• Systems development and implementation
• Change and project governance
• Strategic and business risk

• A — Plan for new systems: The committee should help identify and prioritise systems requirements and ensure planned systems support organisational needs.
• D — Consider competitive issues: New information systems may affect Y’s competitive position, service quality and efficiency. These strategic implications should be considered.
• E — Ensure the system meets company goals: This is a key governance responsibility. The committee should ensure the project remains aligned with Y’s objectives and delivers business value.

• B — Develop new systems: Detailed system development should be performed by IT specialists and project teams, not the steering committee.
• C — Manage the project: The project manager should handle day-to-day project management. The steering committee should provide oversight, challenge and key decisions, rather than manage daily activities.

• Access controls — ensuring only authorized users can access it.
• Encryption — protecting the data if it is intercepted or exposed.

DAX 
Blue Sales = 
CALCULATE( 
    [Total Sales], 
    KEEPFILTERS('Product'[Color] = "Blue") 
)

• CALCULATE evaluates [Total Sales] after applying an additional filter.
• 'Product'[Color] = "Blue" restricts the calculation to blue products.
• KEEPFILTERS ensures the existing filter context is preserved. For example, filters for year, region, or customer remain active. If Color is already filtered, the blue condition is applied as an intersection rather than replacing the existing filter.
• Avoid ALL, because it removes filters and would not maintain the existing context.

• Accept: Acknowledges the risk without taking additional action.
• Transfer: Shifts the risk or financial impact to another party, such as an insurer.
• Mitigate: Reduces the likelihood or impact through controls like patching, MFA, or segmentation.
• Avoid: Eliminates the activity that creates the risk.

• 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.

• 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.

• Outer packet: 10.5.1.1 > 52.165.16.154
• IPv4 protocol field: 41, which indicates IPv6 encapsulation
• Inner packet: IPv6 traffic between 2001:... addresses

• MAC address spoofing: Changes Layer 2 addressing; it does not explain the IPv6-in-IPv4 structure.
• Steganography: Hides data inside files or media, not visibly in a tunneled protocol.
• Broken encryption: No evidence of encryption being cracked.
• On-path sniffing: Involves intercepting traffic, not sending data to an external host.

• 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.

• Base table — the table containing common inherited fields
• Parent table — the table directly extended by the child
• Other tables in the hierarchy

1. Create a temporary Onboarding OU.
2. Move the new account into it.
3. Move the restrictive SCPs from the organization root to the Production OU.
4. Allow the account to update AWS Config.
5. Move the account into Production after onboarding.

• An SCP attached at the organization root applies to every account and OU beneath it.
• An SCP attached to the Production OU applies only to accounts in that OU.
• Therefore, moving the restrictive SCP from the root to Production temporarily exempts the onboarding account without weakening the policies for existing production accounts.
• Once onboarding is complete, moving the account into Production subjects it to the normal restrictions.

• Deterrent control: The signs warning that people may be filmed can discourage unauthorized or malicious activity. They do not directly stop the action; they influence behavior.
• Detective control: CCTV records or monitors activity so security personnel can identify events or investigate them afterward.

• Preventive: Stops an incident from occurring, such as access control.
• Corrective: Restores systems after an incident.
• Directive: Instructs people to behave in a certain way, such as a security policy.
• Compensating: An alternative control used when the preferred control is not feasible.

• Input validation: Prevents malicious or malformed input within an application; it does not authenticate a software package.
• Secure cookies: Protect web-session cookies; they do not protect downloadable software.
• Fuzzing: Tests software by supplying unexpected input to find vulnerabilities; it does not verify software integrity.

• A is valid:

apex 
  for (Account theAccount : AccountList) { 
      // process theAccount 
  }

• D is conceptually valid, using an index:

apex 
  for (Integer i = 0; i < AccountList.size(); i++) { 
      Account theAccount = AccountList[i]; 
  }

• B is invalid because for(AccountList) is not valid loop syntax.
• C is invalid because each item is an Account, not a List.

• Each team’s Bedrock workflow uses a separate IAM service role.
• The role’s Amazon S3 permissions can be limited to only that team’s customer folder or objects.
• This enforces least privilege and prevents one team’s Bedrock application from accessing another team’s data.
• Access is enforced by AWS permissions, not by asking users to provide a customer name in each request.

• A single role with broad S3 access does not provide team-level isolation.
• Asking teams to specify a customer name is not an access-control mechanism.
• Redacting data does not prevent unauthorized access.
• A bucket policy alone is insufficient unless it explicitly enforces the required team-role restrictions.

• Customer information must not be revealed ? PII Detection
• Malicious instructions embedded in images/documents must be blocked ? Prompt Shields

• If the question allows multiple selections, choose PII Detection and Prompt Shields.
• If it requires one selection specifically for the image-based threat, choose Prompt Shields.

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.

• 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.

• 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.

• Prevention costs: Avoiding defects, such as staff training and improved product design. The company has invested in these.
• Appraisal costs: Detecting defects before products reach customers, such as inspection and testing. The planned batch sampling has not been implemented.
• Internal failure costs: Correcting defects found before delivery.
• External failure costs: Dealing with defects after delivery, such as refunds, replacements, complaints and lost sales.

• Relationship cardinality:

• Filter direction:

• Active versus inactive relationships: only active relationships automatically propagate filters.
• Blank or unmatched values: a fact-table value without a matching dimension row can create the model’s blank/unknown member.
• Uniqueness: the “one” side must contain unique values; duplicate keys generally belong on the “many” side.