2004N-0133 - Part 11 Public Meeting; June 11, 2004
  


  

  


  

  
FDA Comment Number : 
  

  
EC10
  



  

  

  



  

  
Submitter : 
  

  
Ms. Jennifer Duggan
  

  
Date & Time: 
  

  
05/14/2004 06:05:01
  



  

  
Organization : 
  

  
GEREQ
  



  

  
Academia
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Questions arise in the application of 21CFR11, specifically electronic signatures, with regard to web-based data capture systems and subject completed questionnaires. How do we assign electronic signatures to study participants while maintaining study participant anonymity?