Implementing Security in a Regulated Environment: Expectations of IRBs and Other Regulatory Groups. Frank J. Manion Fox Chase Cancer Center [email protected] Thursday October 4, 2007. Outline. Background on caBIG project and development of the current security model
Clinical Trial Management Systems (CTMS) Develops a comprehensive set of standards-based tools designed to meet the diverse clinical trials management needs of the Cancer Center community.
Integrative Cancer Research (ICR) Produces tools and interfaces for integration between biomedical informatics applications and data. This will ultimately enable translational and integrative research by providing for the integration of clinical and basic research data.
In Vivo Imaging (IMAG) Creates and validates tools and methods to extract meaning from and share imaging data.
Tissue Banks and Pathology Tools (TBPT) Develops a set of tools to inventory, track, mine, and visualize biospecimen and related annotations from geographically dispersed repositories.
Architecture (ARCH) Develops the fundamental caGRID platform that supports the analytic tools. caGRID is the underlying network architecture and platform that provides the basis for connectivity, tools deployment, and data sharing between caBIG™ participants.
Vocabularies and Common Data Elements (VCDE) Evaluates and integrates systems and standards for vocabularies and common data elements and ontology content development, as well as software systems for content delivery. They also define semantic interoperability, train and provide mentors, and provide guidelines for the adoption of standards and CDE harmonization.
Data Sharing and Intellectual Capital (DSIC) Addresses issues and develops recommendations related to data sharing, patient privacy, intellectual capital, security and other policies related to caGRID as well as other regulatory and proprietary issues.
Documentation and Training (D&T) Defines guidelines, processes, templates and tools for developing consistent software documentation and training materials and for fostering mentoring activities throughout caBIG™.
Strategic Planning (SP) Assists caBIG™ senior leadership with strategic planning and vision development activities.
Modified from https://cabig.nci.nih.gov/overview/howitworks/
Dan Steinberg JD, in https://cabig.nci.nih.gov/working_groups/DSIC_SLWG/Documents/
Requirements regarding data security
Courtesy Ulrich Sax
Additional data protection requirements when dealing with person related data
Courtesy Ulrich Sax