Expertise in the CDISC ODM.  

Expertise in the CDISC ODM.

Assero Limited

  Home
  About Us

  ODM Compliance
  ODM Tools
  Consultancy
  Training

  Resources

  Contact Us

  .................................

  Resources

   Articles
   White Papers
   Presentations
   Industry Events
   Links
   Newsletter
   21 CFR 11
   CSUCT

  .................................

 

FDA Computerized System Used In Clinical Trials (CSUCT)



Below are a series of links to information about the CSUCT document.

Current (1999) Guidance (PDF) (47 Kb)

 

PDF Version of the current guidance document.

Federal Register Announcement (27 Kb)

 

FDA web page containing the FR announcement of the new draft document.

Draft Guidance (PDF) (303 Kb)

 

PDF Version of the new draft guidance document.

Draft Guidance (Word) (110 Kb)

 

Word Version of the new draft guidance document.



    Privacy Policy
Home | Compliance | Tools | Consultancy | Training | Resources | Contact Us

Last Update: 18th October 2008 (R24.0.0)
© Assero Limited: 2003 to 2008