Data and ResourcesRegistry Next-Generation-Sequencing (NGS) tests for oncologyjson Download FieldValue Modified2019-02-14 Release Date2018-05-08 Identifier68f53c1a-6109-4e8b-b7a5-a7f7484f6e8b LicenseCreative Commons Attribution Public Access LevelPublic Protocol Protocol Full title of the projectRegistry Next-Generation-Sequencing (NGS) tests for oncology Name or abbreviated title of the project where availableNGS Commissioner(s) Organisation (1) that commissioned this project Name of organisation (1)National Institute for Health and Disability Insurance Website(s) of organisation (1)Website Organisation (2) that commissioned this project Name of organisation (2)Federal Public Service Health, Food Chain Safety and Environment Website(s) of organisation (2)Website Source(s) of Monetary or Material Support Organisation (1) providing support Name of organisation (1)National Institute for Health and Disability Insurance Website(s) of organisation (1)Website Organisation (2) providing support Name of organisation (2)Federal Public Service Health, Food Chain Safety and Environment Website(s) of organisation (2)Website Governance Governance Is there a Steering / Accompanying committee?No information available General information Objective of the project Main objective of the projectThe general aim of the pilot project NGS is to facilitate the stepwise introduction of the NGS technology within the oncological routine for a total period of 5 years. The collection of the NGS data represents an important added value of this new technology for quality guarantee, HTA evaluations, optimal reimbursement and future research, for clinical and public health applications. Specific aims for the data collection via healthdata.be are: The verification of the scope of the performed tests (within the framework as defined by RIZIV, e.g. art. 33bis). The storage of different types of supplied data. In a later phase, a ‘work space’ can be created where all NGS results will be gathered in a molecular registry which will be accessible to resolve research questions. Additional informationNo additional information available Scope ScopeDiagnosis Legal basis Type of legal basis Type of legal basisUnknown Design of the project Principal inclusion and exclusion criteria Principal inclusion criteriaCancer patients who are entitled to receive molecular profiling by NGS as outlined in the technical parts of the clinical guidelines of the College of Oncology and in line with the recommendations of the “ComPerMed”. Data transfer frequency Data transfer frequencyAd hoc (event based) Method of data transfer Data transfer method(s)eHealthbox of eHealth Platform Sites involved in the project Type of site(s) Care ProviderLaboratories: anatomical pathology Laboratories: clinical biology Laboratories: human genetics Health professionals involved (encoding) in the project Health professionals involved (encoding) in the project Care GiverLaboratory Workers Physicians Specialty of physicians involved (encoding) in the projectPathological anatomy Unknown Type of paramedical professionals involved (encoding) in the projectUnknown Informed consent Informed consent Are subjects informed?Yes Do subjects have to give their consent?Yes How do subjects give their consent?Yes Is there a procedure to provide subjects the ability to consult their registered information?No information available Is there a procedure to provide subjects the ability to correct their registered information?No information available Additional informationNo additional information available Review Ethics Committee Authorization by an Ethics Committee?Not applicable Sectoral Committee National Registry (Privacy Commission) Authorization by the sectorial committee Health / Social affairs of the Privacy CommissionNot applicable Sectoral Committee Health / Social affairs (Privacy Commission) Authorization by the sectorial committee Health / Social affairs of the Privacy CommissionYes Sectoral Committee Crossroads Bank of Enterprises (Privacy Commission) Authorization by the sectorial committee Crossroads Bank of Enterprises of the Privacy Commission (Y/N)Not applicable Data dictionary Classifications and Terminology NameUnknown Data quality Data quality First year for which data is availableNo information available Procedures for checking and validating the source dataNo information available Data compilation processNo information available Punctuality for the most recent completed data collection: the data collection was completedNo information available Participation rate of the health institutionsNo information available Participation rate of the health professionalsNo information available Extent of unit non-responseNo information available Extent of the item non-responseThe rate of item non-response is not known or unacceptably high (>50%) Extend to which the collected data are comparable across the Belgian regionsComparability across the Belgian areas is unknown Comparable or reconcilable over timeComparability over time is unknown Additional informationNo additional information available Extent of problems with the misclassification of statistical units for their key variablesNo information available Can records belonging to same entity be matched?No information available Additional informationNo additional information available Data storage Data storage The organisation in charge of storage of the collected data, is certified as being compliant with the international standards on information security management system (eg. ISO27001)?Yes Additional informationNo additional information available Data access Data access Written Data sharing policy?No information available Request data
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