CDISC Clinical Data Acquisition Standards Harmonization
Abbreviation: CDISC CDASH
Countries that developed this resource United States
How to cite this record FAIRsharing.org: CDISC CDASH; CDISC Clinical Data Acquisition Standards Harmonization; DOI: https://doi.org/10.25504/FAIRsharing.r87bgr; Last edited: Jan. 8, 2019, 1:33 p.m.; Last accessed: Jul 06 2020 5:35 a.m.
Record updated: Nov. 21, 2018, 7:29 p.m. by awhite.
Edits to 'https://fairsharing.org/FAIRsharing.r87bgr' by 'awhite' at 19:29, 21 Nov 2018 (approved): 'supportLinks' has been modified: Before: After: training|https://www.cdisc.org/education/course/cdash-implementation Added: training|https://www.cdisc.org/education/course/cdash-implementation Removed: 'homepage' has been modified: Before: http://www.cdisc.org/cdash After: https://www.cdisc.org/standards/foundational/cdash 'organizations' has been modified: Before: CDISC|https://www.cdisc.org/|Maintains After: CDISC|https://www.cdisc.org/|Maintains Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined Added: Innovative Medicines Initiative (IMI), Europe|http://www.imi.europa.eu|Undefined Removed:
Edits to 'https://fairsharing.org/FAIRsharing.r87bgr' by 'awhite' at 15:43, 09 Nov 2018 (approved): 'miriam_id' has been modified: Before: None After: 'contact' has been modified: Before: After: Ann White 'type' has been modified: Before: reporting guideline After: model/format 'description' has been modified: Before: CDISC open data standards have been developed collaboratively by global volunteers to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting., CDASH V 1.1 includes implementation guidelines and best practice recommendations, regulatory references and other information on the CDASH project. The CDASH Team is currently working on publishing CDASH Model v1.0 and CDASHIG v2.0, which will include major updates to the format and content of the CDASH standard. CDASHIG v2.0 will replace CDASH v1.1 and CDASH UG v1.0. After: CDASH establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review. 'supportLinks' has been modified: Before: help|http://www.cdisc.org/cdash-v1-1 online documentation|http://www.cdisc.org/system/files/members/standard/application/pdf/cdash_std_1_1_2011_01_18.pdf After: Added: Removed: help|http://www.cdisc.org/cdash-v1-1 online documentation|http://www.cdisc.org/system/files/members/standard/application/pdf/cdash_std_1_1_2011_01_18.pdf
No XSD schemas defined
Conditions of Use
No publications available
No guidelines defined
Models and Formats
No identifier schema standards defined
No metrics standards defined
MDM-Portal (Medical Data-Models) is a meta-data registry for creating, analysing, sharing and reusing medical forms, developed by the Institute of Medical Informatics, University of Muenster in Germany. see also http://www.ncbi.nlm.nih.gov/pubmed/26868052 Electronic forms for documentation of patient data are an integral part within the workflow of physicians. A huge amount of data is collected either through routine documentation forms (EHRs) for electronic health records or as case report forms (CRFs) for clinical trials. This raises major scientific challenges for health care, since different health information systems are not necessarily compatible with each other and thus information exchange of structured data is hampered. Software vendors provide a variety of individual documentation forms according to their standard contracts, which function as isolated applications. Furthermore, free availability of those forms is rarely the case. Currently less than 5 % of medical forms are freely accessible. Based on this lack of transparency harmonization of data models in health care is extremely cumbersome, thus work and know-how of completed clinical trials and routine documentation in hospitals are hard to be re-used. The MDM-Portal serves as an infrastructure for academic (non-commercial) medical research to contribute a solution to this problem. It already contains more than 6,000 system-independent forms (CDISC ODM Format, www.cdisc.org, Operational Data Model) with more than 470,000 data-elements. This enables researchers to view, discuss, download and export forms in most common technical formats such as PDF, CSV, Excel, SQL, SPSS, R, etc. A growing user community will lead to a growing database of medical forms. In this matter, we would like to encourage all medical researchers to register and add forms and discuss existing forms.
This record is not implemented by any policy.