Schema References
Link | Type | Description | Date of Upload (Version) | Source |
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SDC Schema and Instances | XSD XML PDF HTML | SDC Schema and Sample Instances Open for Comments | 3/14/2014 | Denise Warzel (NCI) |
Link | Type | Description | Date of Upload (Version) | Source |
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SDC Forms | HTML & XML | Various Instances of SDC Forms Closed For Comments | 1/7/2014 | Denise Warzel (NCI) |
Archive | NA | NA | NA | NA |
Other References
Link | Type | Description | Source |
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CAP eCC Reference Implementation | CDE Requirements Reference | CAP eCC Reference Implementation uses a set of design principles to produce a group of related modular components. | Richard Moldwin M.D., Ph.D. |
CDE Attributes and Form Requirement | CDE and Form Reference | Minimum necessary requirements that should be considered for CDE Metadata and Forms. | Stephen Beller Ph.D |
CaDSR Minimum CDE Criteria | CDE Requirements Reference | Minimum set of caDSR criteria that it needs and uses to specify data elements (common data elements) on its forms. | Denise Warzel (NCI) |
Standards SWG References
Link | Type | Description | File | Source |
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Link | Type | Description | Instructions |
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FDA Adverse Event Reporting Requirements | PDF | Updated requiremetns on FDA Adverse Event Reporting, including Center for Tobacco Products(CTP) | N/A |
ISO/IEC 16262:2011 | Web Site / PDF | Information technology - Programming languages, their environments and system software interfaces. | To view the Standard please click on the link and acknowledge the copyright agreement. Once the copyright agreement is selected the document will be downloaded to your computer for viewing. |
FDA Guidance | Web Site / PDF | Guidance for Industry: Electronic Source Data in Clinical Investigations (Sept 2013) | N/A |