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.

• Guiding principles
• Governance
• Service value chain
• Practices
• Continual improvement

• Guiding principles: Recommendations that guide decisions and actions; they do not describe the entire system.
• Four dimensions: Perspectives used to ensure a balanced approach to service management.
• Service relationship: Describes cooperation between a service provider and service consumer, rather than the whole value-creation system.

• Vulnerability scanner: Finds technical weaknesses in systems, applications, or devices. It does not usually analyze the entire supply chain.
• Penetration test: Simulates attacks against a defined target to identify exploitable weaknesses. Its scope is narrower.
• SCAP (Security Content Automation Protocol): Provides standardized formats and methods for automating security configuration and vulnerability checks, rather than mapping the full supply chain.

• Digitally signing the software: Verifies authenticity and integrity. It does not hide how the software works.
• Limiting third-party libraries: May reduce dependencies and attack surface, but does not directly prevent reverse engineering.
• Using compile flags: Some compiler options can remove debugging information or optimize code, which may provide limited protection, but this is not the primary technique identified for preventing reverse engineering.

• Espionage: Stealing information for intelligence or competitive purposes.
• Data exfiltration: Unauthorized removal or transfer of data.
• Nation-state attack: An attack sponsored or conducted by a government.
• Shadow IT: Technology or access methods used outside approved IT processes.

• 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.

Statement 1 — Correct

Statement 2 — Correct

• B. Deploy to a SageMaker endpoint: This is needed for SageMaker-hosted models, not for a model intended to be used directly in Amazon Bedrock.
• C. Register with SageMaker Model Registry: SageMaker Model Registry is unrelated to invoking custom models in Bedrock.
• D. Grant access in Bedrock: Access permissions may be necessary, but they do not replace the required provisioned capacity.

• 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.

• How quickly the vendor must respond to an incident or request
• Target resolution times
• Availability or uptime requirements
• Performance metrics and penalties for not meeting them

• SOW (Statement of Work): Describes the project’s scope, tasks, deliverables, and timeline.
• MOA (Memorandum of Agreement): Documents a formal agreement to cooperate or perform specific activities.
• MOU (Memorandum of Understanding): Records a mutual understanding or intent, often less binding than a contract.

1. Create a custom Sensitive Information Type (SIT) in the Microsoft Purview portal.
2. Use a regular expression to match the 32-character alphanumeric account number.
3. Reference that SIT in the DLP policy protecting SharePoint Online.

• Format-based data ? custom SIT with RegEx
• Built-in sensitive data ? Microsoft-provided SIT
• Document classification/protection ? sensitivity labels
• Security investigation queries ? Advanced Hunting, not DLP detection

• ARP poisoning: Redirects or intercepts local network traffic; monitoring would typically show suspicious ARP changes or man-in-the-middle behavior.
• Jamming: Interferes with wireless or radio signals. It would affect connectivity, not usually show a server-specific overload.
• Kerberoasting: Attempts to obtain and crack Kerberos service-account hashes; it does not normally cause a system outage.

• BCP (Business Continuity Plan): è più ampio e mira a mantenere le funzioni essenziali dell’organizzazione durante un’interruzione. Il DRP è una componente più specifica del BCP.
• Communication plan: stabilisce come comunicare con dipendenti, cittadini e altre parti interessate, ma non ripristina i sistemi.
• IRP (Incident Response Plan): gestisce la risposta iniziale a un incidente di sicurezza, come un attacco informatico, non principalmente il recupero da un disastro fisico.

• Data loss prevention (DLP): Helps detect or prevent sensitive data from being copied or transmitted, but it does not primarily protect a stolen laptop’s stored data.
• Operating system hardening: Reduces vulnerabilities and attack surface but does not encrypt files if the device is stolen.
• Boot security: Helps ensure that only trusted software starts, but it does not fully protect the drive if an attacker accesses it offline.

1. x = -100
2. -100 < x < 100
3. 100 = x < 1000
4. x = 1000

• -500 ? class 1
• 0 ? class 2
• 100 ? class 3
• 1000 ? class 4

• 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.

• 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.

• Accept: Acknowledging the risk without taking additional action.
• Transfer: Shifting responsibility or financial impact to another party, such as through insurance or outsourcing.
• Mitigate: Reducing the likelihood or impact of the risk through controls.
• Avoid: Eliminating the activity or condition that creates the risk.

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

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

• Application management: Controls which apps can be installed or used; it does not remove existing data after theft.
• Full-disk encryption: Protects data when the device is powered off or locked, but it may not help if the attacker has already unlocked the device.
• Containerization: Separates corporate data from personal data, but the attacker may still access the corporate container using the stolen credentials.

• A: Configure security groups — Customers define inbound and outbound rules for resources such as Amazon EC2 instances.
• B: Classify company assets — Customers decide how their data and assets should be classified and protected.

• C: Amazon S3 is a regional service; customers select a Region, not individual Availability Zones for buckets.
• D: AWS manages the infrastructure and patching for Amazon DynamoDB.
• E: AWS manages the infrastructure used by AWS Lambda; customers do not select EC2 instances for Lambda functions.

• Suporta domínios personalizados.
• Oferece 50 GB de armazenamento — suficiente para os 10 GB de cada aplicação.
• Usa instâncias de computação dedicadas.
• Inclui balanceamento de carga entre instâncias.
• É o plano mais econômico entre as opções que atendem a todos esses requisitos.

Question 3: AWS Storage Gateway File Gateway

• A: S3 bucket per user — S3 is object storage, not a traditional shared file system; mounting it requires extra tools and is less efficient.
• B: File Gateway — Provides a local file share using standard file protocols while storing files in Amazon S3. This preserves convenient local access and extends storage capacity.
• C: WorkSpaces and WorkDocs — Designed for virtual desktops and document collaboration, not large shared file storage.
• D: EC2 with EBS — EBS is attached to one EC2 instance and is not designed for direct multi-user file sharing.

• Existing measures
• Relationships
• Calculated columns
• Tables and fields
• Existing transformations in the model

• SharePoint folder: Reconnects to the source files. You would likely need to recreate the model and measures.
• Power BI dataflows: Primarily provide reusable data preparation and storage, but they do not automatically provide the existing semantic model and measures.
• Excel workbook: Connects directly to the source file and would also require rebuilding the model and measures.

• A — Correct: Flow Builder is declarative and visual, so administrators and other non-developers can participate in designing and improving business processes without writing Apex.
• D — Correct: Flow Builder provides visual debugging tools, allowing an admin to test paths, inspect variable values, and identify where a specific business case fails.
• E — Correct: A flow’s visual structure documents the logic and makes later maintenance easier than reading and updating custom Apex code.

• B — Incorrect: Flow debugging does not attach a debugger to live customer sessions. The admin uses Flow Builder’s debug functionality with test inputs; this is not live-session debugging and should not be used to monitor real customer transactions.

• Error correction (ECC): Improves data reliability but does not maximize bandwidth.
• RAM voltage: Increasing voltage may affect stability or speed, but it is not the primary method for increasing module bandwidth.
• Physical module size: Refers to the capacity or form factor of the RAM, not its data-transfer bandwidth.

• Accept: Acknowledge the risk and choose not to take additional action.
• Transfer: Shift the risk or its financial impact to another party, such as through insurance or outsourcing.
• Mitigate: Reduce the likelihood or impact of the risk, such as by implementing security controls.
• Avoid: Eliminate the activity or condition that creates the risk.

• Existing expected ROI: 15%
• New project ROI: 14%
• Cost of capital: 12%

• Project return = 14%
• Cost of capital = 12%
• It earns 2% more than the cost of capital, so it should increase shareholder value.

• Replaces the verbal message — this describes non-verbal communication being used instead of words.
• Substitutes for verbal communication — similar; it means communicating without speech.
• Confuses the verbal message — this occurs when non-verbal signals contradict or obscure the spoken message.

• 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.

• 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.

• 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.

• Due diligence: Investigating and evaluating a third party before entering into or continuing a business relationship.
• Attestation: An independent party provides assurance about an organization’s claims or controls. A SOC 2 examination is an example of an attestation engagement, but the analyst requesting and reviewing the report is performing due diligence.
• Internal audit: Reviews the organization’s own internal controls.
• Penetration testing: Actively tests systems for exploitable vulnerabilities.

• Have a definite, clear objective (C): Know exactly what you want to communicate. A clear purpose reduces ambiguity and irrelevant information.
• Plan the communication (E): Decide what to say, who needs the information, the appropriate channel and the best timing.
• Seek feedback (F): Check that the receiver understood the message. This could involve asking for confirmation or inviting questions.

• Ask questions (A): Usually associated with the receiver checking or clarifying information, although a sender may use questions in practice.
• Give feedback (B): Feedback is generally the receiver’s response to the sender’s message. The sender’s responsibility here is to seek feedback.
• Consider their contribution (D): This is not a standard sender-focused step in the communication process. The sender should consider the receiver’s needs and perspective, but the wording is less precise than the three recognised actions above.

• C — Some risks cannot be eliminated.

• D — Accepting residual risk does not imply recklessness.

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

• 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.

Why this is correct

• Each user authenticates with their own Google account.
• Google manages the user’s SSH key association.
• IAM controls who can access instances.
• Access can be audited by user identity, so security can determine who accessed a VM.
• Granting the role to a Google group avoids managing permissions individually.

Why the others don’t apply

• A: A shared private key is difficult to distribute securely and cannot reliably identify which employee used it.
• B: Manually collecting and deploying keys on every instance is operationally inefficient and complicates auditing.
• D: A project-wide shared key has the same identity and key-management problems as option A. It also does not provide per-user accountability.

• 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.

• Virtual machine disks
• Databases
• Storage accounts
• File systems

• Site-to-site VPN: protects data moving between networks
• HTTPS: protects data moving between a client and website
• Encrypted email: generally protects the message while being transmitted

• At rest = stored data
• In transit = moving data
• In use = data currently being processed by a system

• A is correct: It establishes the revised dates and identifies the effect on the critical path.
• B is premature: Stakeholders should be informed after the impact has been assessed and the updated schedule is understood.
• C is not automatically appropriate: Fast-tracking may introduce additional risk and should be considered only after analyzing schedule options.
• D is premature: Adding resources may not resolve a dependency and could increase costs without addressing the actual constraint.

• Menerjemahkan soal ke bahasa Indonesia.
• Menyebutkan jawaban yang benar.
• Menjelaskan alasan jawaban tersebut.
• Memberi tahu jika kunci jawaban yang tersedia tampaknya keliru.
• Menjelaskan istilah teknis penting dalam soal.

• Cloud architecture
• Data architecture
• Platform engineering
• Data engineering
• Provisioning and modernization

• Data protection is associated mainly with security and risk management.
• Data governance belongs to the governance perspective.
• Data science is not an AWS CAF capability.

• 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.

• 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.

1. Define – establish the project’s objectives, scope, feasibility and requirements.
2. Design – plan how the project will be carried out, including resources, schedules and controls.
3. Deliver – execute the project and produce the required outputs.
4. Develop – close the project formally and capture learning for future projects.

• Filing documentation and records
• Closing project and accounting systems
• Settling costs
• Handing over the completed work and obtaining sign-off
• Reviewing performance and giving feedback

• Maintain head office control: Transfer pricing generally supports decentralisation rather than direct head-office control.
• Establish centralised decision making: This conflicts with divisional autonomy.
• Develop a top-down culture: Transfer pricing is intended to support empowered divisions and goal congruence, not impose purely top-down management.

• 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.