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Begrippenlijst(en) / Glossary
RDM support desks
Also: BIV classificatie. Classification of information, systems, or applications regarding confidentiality (
), integrity (
), and availability (
). Not all types of information and systems have to meet the same standards for security. This classification system helps to determine the desired level of security.
A study involving human participants to investigate the efficacy and/or safety of one or more medicines or other health-related interventions.
Clinical Trial Monitors
Sponsored clinical trials have monitors who make sure that the primary data are collected and recorded properly. They meet periodically with research coordinators and review their study records. They ensure that the reporting of adverse events is complete. This very useful auditing function serves to promote Good Clinical Practices and to enhance the compulsive collection of data. It is required by the FDA, which does not like to review incomplete studies. These monitors do not relate to the subjects. Within the framework of Workspace, the Data Cleansing Zone provides the support for the Monitors.
Data and Safety Monitoring Boards
A type of Internet-based computing that provides shared computer processing resources and data to computers and other devices on demand. It is a model for enabling ubiquitous, on-demand access to a shared pool of configurable computing resources (e.g., computer networks, servers, storage, applications and services), which can be rapidly provisioned and released with minimal management effort. Cloud computing and storage solutions provide users and enterprises with various capabilities to store and process their data in third-party data centers that may be located far from the user–ranging in distance from across a city to across the world. Cloud computing relies on sharing of resources to achieve coherence and economy of scale.
Coding or Pseudonymisation
Pseudonymisation or Coding
A group of individuals identified by common characteristic(s) (e.g., demographic, exposure, illness) or studied over time using a common protocol.
This is a collaboration management platform (funded by NSF and Internet2) that allows collaboration members to share IT services in a secure environment. By using federated identity management services, the authentication and authorization of members can be handled by a single predefined process. For instance, it can automatically set access control for (scientific) IT services available for the collaboration.
Common denominators extraction
Comparisons between SOLL architectures to extract common denominators -working towards (an update of the) RDM Reference Architecture.
facilitates common denominator extraction.
The cloud infrastructure is provisioned for exclusive use by a specific community of consumers from organizations that have shared concerns (e.g., mission, security requirements, policy, and compliance considerations). It may be owned, managed, and operated by one or more of the organizations in the community, a third party, or some combination of them, and it may exist on or off premises.
The ethical and legal obligation of an individual or organization to safeguard data or information by controlling access as authorized by law or by the data donor.
Conflict of Interest
One or more connections or interests (personal, social, financial or professional) that influence, or could be perceived to influence, professional integrity and independence.
Voluntary and informed expression of the will of a person, or if incompetent, his/her legal representative.
Controlled or Restricted Access
Access to data that is subject to conditions and an approval process.
Current Research Information System (CRIS)
A database or other information system to store and manage data about research conducted at an institution. A standard for current research information system is the CERIF (Common European Research Information Format) standard, proposed by the EU and developed and maintained by euroCRIS.
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