RAPS RAC-GS Exam Prep
Regulatory Affairs Certification (RAC) Global Scope (Page 10 )

• 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.

• Repetitive and time-consuming
• Based on measurable conditions, such as last check-in time
• Easy to automate with alerts, dashboards, or scheduled reports
• Important for ensuring scan coverage

• Assigning custom recommendations usually requires analyst judgment and context.
• Analyzing false positives can sometimes be assisted by automation, but validation often requires human review.
• Rendering an additional executive report increases reporting activity rather than reducing a core operational workload.

• 25 – Traditional SMTP server-to-server mail transfer; often blocked for client submission and not inherently secure.
• 110 – POP3 for receiving email; unencrypted by default.
• 143 – IMAP for accessing email; unencrypted by default.
• 587 – Authenticated email submission and commonly secured with TLS.

• Security controls
• Processes and procedures
• Compliance evidence
• Performance against contractual requirements

• Service-level agreement (SLA): Defines expected service performance, such as uptime and response times.
• Memorandum of agreement (MOA): Documents a general agreement between parties, but does not necessarily provide audit rights.
• Supply chain analysis: Identifies risks across suppliers and dependencies, but is not a contractual mechanism for reviewing vendor controls.

• Amazon SageMaker — charges apply for compute, storage, and other resources used.
• AWS Config — generally charges for configuration recording and rule evaluations.
• Amazon CloudWatch — has a limited free tier, but many metrics, logs, alarms, and API usage can incur charges.

• Espionage: Stealing confidential information, often for a competitor or foreign entity.
• Data exfiltration: Unauthorized removal or transfer of data.
• Nation-state attack: A cyberattack sponsored or conducted by a government.
• Shadow IT: Unapproved technology or services used outside IT oversight.

• 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.

• Accept: Acknowledging the risk and choosing not to take additional action.
• Transfer: Shifting the risk or financial consequences to another party, such as an insurer.
• Mitigate: Reducing the likelihood or impact through controls, such as patching or access restrictions.
• Avoid: Eliminating the activity that creates the risk.

• 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.

• C — Create a form extension and implement validation

• D — Use Chain of Command (CoC) with a form extension class

• 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.

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

• VLAN 10 for data
• VLAN 20 for voice

• A: Describes physical trunking or logical switch ports, not an SVI.
• B: An SVI can provide management access, but that is only one use—not the best description here.
• D: SVI use is not related to running out of physical ports.

• 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.

• Document feeder: A scratch, dirt, or debris on the feeder glass or rollers can create a line on every scanned image.
• Pickup rollers: Move paper through the printer; they would not normally create a scanner-only line.
• Corona wire: Affects toner charging and would cause defects on printed output.
• Drum assembly: Also affects printed pages, so faxes and computer print jobs would show the line too.

1. Search & Intelligence in the Microsoft 365 admin center — No

1. Audit in the Microsoft Defender portal — Yes

1. Audit in the Microsoft Purview portal — Yes

• \Pipeline1
• \Folder1\Lakehouse1

• Pipeline1 remains at the workspace root in Workspace1, so it is deployed to the root of Workspace2.
• Lakehouse1 was moved into Folder1, so its full path is preserved as \Folder1\Lakehouse1.
• Fabric deployment pipelines preserve folder paths because an item’s full path is treated as part of its name.

• 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.

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:

• Assign endpoints to a group based on the result of one policy.
• Use that group as the scope of another policy.
• This effectively passes the endpoints from one policy’s processing flow to another.

• True positive: The scan reports a vulnerability that really exists.
• False positive: The scan reports a vulnerability that does not exist.
• True negative: The scan correctly reports no vulnerability.
• False negative: The scan fails to detect a vulnerability that is actually present.

• Load balancer: Distributes application traffic; it does not protect switch MAC tables.
• IPS: May detect some attack traffic, but it is not the primary control for switch-port MAC learning.
• NGFW: Protects at network boundaries but does not directly limit MAC addresses learned on access ports.

• 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.

• Reconnaissance: Gathering information about the target.
• Weaponization: Creating or combining a malicious payload with a delivery method.
• Delivery: Sending the payload, such as through phishing.
• Exploitation: Triggering a vulnerability or weakness to gain execution or access.

• New investment: $536,500
• Resulting NPV: $0

Manager role

DAX 
Country[Manager] = USERPRINCIPALNAME()

• Sales
• Human Resources

CFO role

• See sales for all countries
• See no Human Resources data

• Do not restrict the Country table or Sales table.
• Apply a filter to Human Resources that always returns false, such as:

DAX 
FALSE()

• A — .gitignore: Controls Git tracking; it does not configure Copilot exclusions.
• B — copilot.ignore: This is not the standard GitHub Copilot Business exclusion mechanism.
• D — Renaming files: Adding _no_copilot has no recognized effect.

• Due diligence: Investigating and evaluating a third party before entering a business relationship.
• Attestation: An independent auditor’s examination and formal report—such as the SOC 2 report itself. The analyst is reviewing the attestation, not performing it.
• Internal audit: Examines the organization’s own processes and controls.
• Penetration testing: Actively tests systems for exploitable vulnerabilities.

• A — If there is no demand, there should be no production.

• B — Not all sales equal profit.

• C — Stocking up on inventory is bad for business.

• D — All costs, except materials, are considered fixed.

• E — Departments should operate at full capacity regardless of bottlenecks.

• 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.

• 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.

• Physical: Protects facilities or equipment, such as locks and security cameras.
• Technical: Uses technology, such as firewalls, encryption, or access controls.
• Operational: Covers day-to-day actions and processes, such as training, backups, or incident response.
• Managerial: Includes policies, standards, risk assessments, and procedures.

• 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.

• 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.

• Install unauthorized or unapproved applications
• Access system areas normally restricted
• Add features unavailable in the default software
• Modify the device’s operating system

• SQL injection (SQLi): Attacks databases by inserting malicious SQL commands.
• Cross-site scripting (XSS): Injects malicious scripts into web pages viewed by users.
• Sideloading: Installs an application from outside the official app store, but it does not necessarily remove the phone’s operating-system restrictions.

Correct reasoning

• Create storage5 as a General-purpose v2 (StorageV2) account.
• Configure Blob object replication from storage5 to an existing compatible storage account.
• The destination must support object replication—typically another StorageV2 or premium block blob account.
• Blob versioning must be enabled on both accounts.
• Blob change feed must be enabled on the source account.
• The accounts must meet Azure’s object-replication requirements, including being in supported regions and having compatible configuration.

1. Create Workspace2 with Lakehouse2 — F
2. Migrate the Employee table to Lakehouse2 — E
3. Assign the data engineer the Contributor role for Workspace1 — D

Why

• Sharing Lakehouse1 would not provide the required isolation.
• Viewer access would not allow writing to Customer.
• Giving Contributor access to Workspace2 would expose the sensitive table.

• B — The most significant risks are held by SQ.

• C — SQ should recognise the cars as inventory.

• F — SQ recognises revenue when LM sells a car to a third party.

• A: LM does not hold the most significant risks.
• D: LM does not recognise the cars as inventory.
• E: SQ should not recognise revenue when cars are merely delivered to LM.

• 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.

• The job keeps 31 days of regular restore points. A backup from the week of January 1 is older than 31 days by March 20, so it is no longer expected to remain on the performance tier.
• It is also a weekly GFS full backup, retained for 14 weeks. Therefore, it is still protected and has not been deleted.
• In a Scale-out Backup Repository, older backups can be moved from the performance tier to the capacity tier—typically object storage—according to the configured offload policy.
• The archive tier is not selected because the question’s configuration does not indicate that the backup has been archived there.

• A password cracker would normally be identified by behavior such as loading password hashes or attempting dictionary/brute-force attacks.
• The question describes a routine audit, not password recovery.
• Simply encountering a protected file during an audit is characteristic of a misconfigured or insufficiently privileged FIM.

• 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.

• Three DHCP scopes: Each VLAN has its own IPv4 subnet. DHCP scopes are subnet-specific, so create one scope for:

• Two DHCP relays: DHCP client discovery begins as a broadcast, and broadcasts do not cross routers or VLAN boundaries. Therefore, configure a DHCP relay on the router or Layer 3 switch interface for each client VLAN.

• 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.

• state preserves the client’s original context, such as the specific idea URL the user requested.
• The portal sends that value in the OAuth authorization request.
• Salesforce returns it after authorization, allowing the portal to redirect the user to the original idea rather than the Ideas home page.

• What information each stakeholder needs
• When and how often it should be communicated
• Which format or channel should be used
• Who is responsible for communicating it

• A: The team should not decide stakeholder communications without first checking the established plan and CEO’s needs.
• B: An executive summary may be appropriate, but choosing a solution before reviewing the plan is premature.
• D: The stakeholder engagement plan addresses how to engage stakeholders, but this is primarily a communication planning issue.

• A static IP gives the surveillance system a predictable local address, so users can reliably reach it on the LAN.
• However, a static IP does not block internet-based login attempts. If the router exposes the device through port forwarding, attackers could still reach it.
• Port mapping normally exposes an internal service externally, so A is a poor choice as written.
• Subnetting alone also does not block traffic; it would require routing/firewall rules.

• 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.

1. insert con; ? 1
2. Database.setSavepoint(); ? 2
3. update con; ? 3
4. Database.rollback(sp_admin); ? 4

• NAT traversal: Helps WAN Edge, vSmart, and vManage devices discover how to reach one another through NAT.
• Initial orchestration: Authenticates and introduces devices when they first join the SD-WAN fabric.
• Connection brokering: Provides information that allows devices to form their required control connections, after which the vBond is generally not in the data path.

• WAN Edge: Forwards user traffic and forms secure tunnels.
• vSmart: Controls the overlay control plane and distributes routes and policies.
• vManage: Provides centralized management, configuration, and monitoring.