FDA SDS - Study Data Standards Resources Homepage
https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources
Provides access to...
- eCTD Resources
- FDA Study Technical Conformance Guide (check always SDS Homepage for latest Version)
- FDA Data Standards Catalogue (check always SDS Homepage for latest Version)
- FDA Guidances (requirements for electronic submission of clinical and non-clinical data under section 745A(a))
- FDA Business and Validator Rules (check always SDS Homepage for latest Version)
and more.
FDA - Portable Document Formats (PDF) Specifications
https://www.fda.gov/files/drugs/published/Portable-Document-Format-Specifications.pdf
(current Version: v4.1 - Sep'2016)
NCI EVS - National Cancer Institute Enterprise Vocabulary Service
Provides access to...
- FDA Terminology
- Med-RT (previous NDF-RT)
- MeSH
- SNOMED
- CDISC Terminology
and a lot more...
CDISC "Standards" Homepage
https://www.cdisc.org/standards
provides access to ...
- Foundational Standards (PRM, SEND, CDASH, SDTM, SDTMIG, ADaM, QRS, Controlled Terminology, SDTM/ADaM Supplements)
- Data Exchange Standards (CTR-XML, ODM-XML, SDM-XML, Define-XML, Dataset,-XML, CDISC RDF, CDISC ODM-LAB)
- Therapeutic Area (TA) Standards
- CT Standards (NCI Subpage)
Direct links to other useful standards...
PhUSE Homepage
Archives (CAVEAT on th ePhUSE archives as there are two different one's and they seem to be NOT crosslinked! So whenever you search for something and do not find it in the one archive, it's worth to give it a try in the other archive...)
Deliverables Archive (only accessible from homepage>Working Groups>Deliverables)
https://phuse.global/Deliverables/1
Phuse Archive (different archive than above...)
https://phuse.global/Communications/PHUSE_Archive/1
UCUM Organisation Homepage (Unified Code for Units of Measure)
LOINC Organisation Homepage (Logical Observation Identifiers Names and Codes)
COSA Homepage (CDISC Open Source Alliance Initiative)
provides access to multiple instruments, here only a view...
- Smart Submission Dataset Viewer (direkt link to Sourceforge repository page)
- Define-XML Stylesheets (v2.0 and v2.1)
- Define-XML Editor
and a lot more....