A newsletter for those involved in clinical trials. Published 20 times a year by Canary Ltd

Common Technical Document

The following articles on this topic have been published in CRAdvisor (CRA) – the year, issue number and starting page number for each are listed below:

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2004  
CRA 2004; 132:5   Revised Q & A for Common Technical Document.
CRA 2004; 135:7   New CTD guidance.
CRA 2004; 142:12   Increase in IT spending for clinical trials.
   
2003  
CRA 2003; 104:8   Latest European regulatory activities.
CRA 2003; 105:1   ICH process continues with good progress: CTD soon mandatory.
CRA 2003; 109:7   Guidance for eCTD.
CRA 2003; 115:5   Updated Common Technical Document.
CRA 2003; 118:6   CBER guidance for eCTD.
CRA 2003; 120:5   Common Technical Document causes UK regulatory delays.
CRA 2003; 121:8   More guidance on CTD.
   
2002  
CRA 2002; 84:3   FDA encourages CTD submissions.
CRA 2002; 90:5   eCTD specification at ICH Step 3.
CRA 2002; 90:6   Common Technical Document questions and answers.
CRA 2002; 90:6   Revised version of CTD.
CRA 2002; 93:8   EU Directive 2001/83/EC revision.
CRA 2002; 98:1   ICH update: ready for electronic CTD submissions.
CRA 2002; 99:1   Marketing authorisation directive already out of date.
CRA 2002; 99:8   New regulatory documents.
   
2001  
CRA 2001; 60:1   Common Technical Document released.
CRA 2001; 60:1   Significant progress reported at ICH 5.
CRA 2001; 66:6   Guidance on CTD.
CRA 2001; 70:1   Europe prepares for Common Technical Document.
CRA 2001; 71:2   ICH Steering Committee report continued progress.
   
2000  
CRA 2000; 45:1   ICH reports remarkable progress on CTD.
CRA 2000; 54:6   ICH products latest.
   
1999  
CRA 1999; 26:1   ICH process continues to make progress. 
   
1998  
CRA 1998; 15:1   Significant progress with ICH Common Technical Document. 
CRA 1998; 16:1   Significant progress with ICH Common Technical Document.

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