learning clinical

Clinical data is data pertaining to actual observation and treatment of patients.

http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc :

http://www.xml4pharma.com/CDISC/index.html

http://www.d-wise.com/blog/2012/04/26/keep-pace-with-cdisc/

http://cdiscguru.blogspot.com/

 

http://www.jiangtanghu.com/blog/2012/05/04/cdisc-blog/

http://info.bioclinica.com/author-bio-jennifer-price

http://www.lexjansen.com/pharmasug/

SDTM Basics :

CDISC SDTM : Model

CDSIC Define XML : Metadata

General classes of observations on subjects I,E,F : Interventions, Events, Findings

General structures : Identifiers, Topic variables, Timing variables, qualifiers

Model : wraps the observations

Domain : series of observations

Role:

  • Identifier variables – identify the study, the subject. domain, sequence number
  • topic variables (name of the test)
  • timing variables (start and end date)
  • qualifier variables (numeric units)
  • rule variables (algorithim)

Clinical Trials

SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM.

http://support.sas.com/documentation/cdl/en/cdisc/60755/PDF/default/cdisc.pdf

http://www.lexjansen.com/cdisc/

http://www.dataroundtable.com/

http://www.phusewiki.org/wiki/index.php?title=Annual_Conference

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