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

Monitoring and monitors

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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2007  
CRA 2007; 188:4 Temporary employment in clinical research - is the German experience a model for the rest of Europe?
CRA 2007: 190:2 US sponsor fails in trial conduct responsibilities.
CRA 2007; 194:7 Observant monitor spots signs of fraud leading to investigator prosecution.
CRA 2007; 195:5 Florida-based sponsor violates device regulations.
   
2006  
CRA 2006; 165:6 Essential document management and field-based clinical research staff.
CRA 2006; 176:12 US PhRMA responds on BIMO.
   
2005  
CRA 2005; 158:3 Sponsors fail to meet regulatory obligations.
   
2004  
CRA 2004; 125:2 New employment trends in European clinical research.
CRA 2004; 129:5 Making your sites suitable for trials: documents and filing.
   
2003  
CRA 2003; 110:6 New publications from BARQA.
CRA 2003; 115:1 The monitor's role in 21 CFR Part 11 compliance.
   
2002  
CRA 2002; 93:7 Rationale for interim monitoring of clinical trials.
CRA 2002; 98:3 Spotting fraud in clinical trials. 
   
2001  
CRA 2001; 69:5 How to improve subject compliance in trials.
   
2000  
CRA 2000; 40:1 Do monitors break the law by collecting trial materials from the study site? 
CRA 2000; 40:4 Planning to minimise failure. 
CRA 2000; 40:4 The best way to get started. 
CRA 2000; 47:3 Deficiencies in site selection and study initiation should be avoided. 
CRA 2000; 50:5 Complex protocol cause problems. 
CRA 2000; 56:2 Problems of drug-herb interactions in clinical trials. 
CRA 2000; 59:3 Managing megatrials.
   
1999  
CRA 1999; 22:1 Inadequate monitoring will precipitate warning letters! 
CRA 1999; 22:4 Is the monitor always right? 
CRA 1999; 25:2 Electronic communications and clinical trials. 
CRA 1999; 28:2 CRA salaries surveyed in the USA. 
CRA 1999; 29:4 SOPs for use of yellow stickers. 
CRA 1999; 29:4 Monitors must avoid losing credibility. 
CRA 1999; 32:1 FDA intolerant of poor monitoring. 
   
1998  
CRA 1998; 3:4 Are trial nurses more important than monitors? 
CRA 1998; 4:1 Sponsors’ CRAs less productive than those of CROs!  
CRA 1998; 4:4 Good monitoring practice. 
CRA 1998; 9:5 Strategies for the training and management of CRAs. 
CRA 1998; 11:3 Strategies for the training and management of CRAs. 
CRA 1998; 16:2 Beware of the hazards of fast-track recruitment. 
CRA 1998; 16:4 A time limit for data queries? 
CRA 1998; 16:5 Tips on patient recruitment and study management. 

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