Official websites use. Share sensitive information only on official, secure websites. More than ever, organizations must balance a rapidly evolving cybersecurity and privacy threat landscape against the need to fulfill business requirements on an enterprise level. Risk management underlies everything that NIST does in cybersecurity and privacy and is part of its full suite of standards and guidelines.
To help organizations to specifically measure and manage their cybersecurity risk in a larger context, NIST has teamed with stakeholders in each of these efforts. Examples include:. The increasing frequency, creativity, and variety of cybersecurity attacks means that all enterprises should ensure cybersecurity risk receives the appropriate attention along with other risk disciplines — legal, financial, etc.
Risk occurs across the spectrum of government and its various enterprises, systems-of-systems, and individual systems. At the system level, the risk focus typically centers on development. Risk exists in operations, requirements, design, development, integration, testing, training, fielding, etc. For systems-of-systems, the dependency risks rise to the top. Working consistency across the system-of-systems, synchronizing capability development and fielding, considering whether to interface, interoperate, or integrate, and the risks associated with these paths all come to the forefront in the system-of-systems environment.
At the enterprise level, governance and complexity risks become more prominent. Governance risk of different guidance across the enterprise for the benefit of the enterprise will trickle down into the system-of-systems and individual systems, resulting in potentially unanticipated demands and perhaps suboptimal solutions at the low level that may be beneficial at the enterprise level.
System-level risk management is predominantly the responsibility of the team working to provide capabilities for a particular development effort. Within a system-level risk area, the primary responsibility falls to the system program manager and SE for working risk management, and the developers and integrators for helping identify and create approaches to reduce risk.
In addition, a key responsibility is with the user community's decision maker onwhen to accept residual risk after it and its consequences have been identified. The articles in the Risk Management topic area provide guidance for identifying risk Risk Identification , mitigating risks at the system level with options like control, transfer, and watch Risk Mitigation Planning, Implementation, and Progress Monitoring , and a program risk assessment scale and matrix Risk Impact Assessment and Prioritization.
These guidelines, together with MITRE SEs using tools such as those identified in the Risk Management Tools article, will help the program team deal with risk management and provide realism to the development and implementation of capabilities for the users.
In contrast, little exists on how risk management principles apply to a system whose functionality and performance is governed by the interaction of a set of highly interconnected, yet independent, cooperating systems.
Such systems may be referred to as systems-of-systems. A system-of-systems can be thought of as a set or arrangement of systems that are related or interconnected to provide a given capability that, otherwise, would not be possible. Get Free Test Access.
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This category only includes cookies that ensures basic functionalities and security features of the website. The monitoring plan should include trial-specific instructions for all team members, which include not just the Monitors but also Protocol and Project Managers, Data Managers, Statisticians and sometimes clinical operations groups, to monitor and proactively mitigate risk.
Instructions enable key players to make sure that the clinical trial is conducted, recorded and reported in accordance with the protocol, standard operating procedures, Good Clinical Practice GCP and applicable regulatory requirements The monitoring plan should define what activities will be conducted Off-site and Centralized, as well as those that must be performed On-site. Monitoring activities are aligned with the Overall Risk Level assigned at the protocol level; if Overall Risk Level changes at various stages of the study, the monitoring activities may change accordingly.
The pharmaceutical industry is working to improve safety and quality in clinical trials.
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