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

Declaration of Helsinki

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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2006  
CRA 2006; 176:6 World Medical Association Declaration of Helsinki.
   
2005  
CRA 2005; 149:1 European Commission Directive on GCP 2005/28/EC now published.
   
2004  
CRA 2004; 126:1 WMA working group seeks further advice on Declaration of Helsinki.
CRA 2004; 133:6 No change to Helsinki - but clarification to be issued.
CRA 2004; 133:6 FDA to revise regulations on foreign studies.
CRA 2004; 136:11 FDA is changing attitude on the acceptability of foreign studies.
CRA 2004; 137:8 Declaration of Helsinki proposal likely to be accepted at WMA General Assembly.
CRA 2004; 140:1 World Medical Association endorses changes to Declaration of Helsinki.
   
2003  
CRA 2003; 103:4 Governance arrangements for RECs 'a move away from the principles of the Declaration of Helsinki'.
CRA 2003; 112:8 Trials in developing countries.
CRA 2003; 114:5 Will a new Declaration of Helsinki solve the debate on placebo-controlled trials?
CRA 2003; 117:3 Declaration of Helsinki latest.
CRA 2003; 118:1 WMA to continue debate on Declaration of Helsinki.
CRA 2003; 122:4 Your chance to influence the WMA!
   
2002  
CRA 2002; 82:1 Will Helsinki be revised in 2002?
CRA 2002; 90:1 EU Directive 2001/83/EC requires adherence to Helsinki 2000.
CRA 2002; 90:4 Declaration of Helsinki - which version?
CRA 2002; 99:1 Marketing authorisation directive already out of date.
CRA 2002; 99:6 Guidance for IRBs.
CRA 2002; 100:6 World Medical Association's Declaration of Helsinki.
   
2001  
CRA 2001; 60:6 Declaration of Helsinki conference.
CRA 2001; 62:1 Does a patient always get the best proven treatment?
CRA 2001; 62:2 Changes to the Declaration of Helsinki.
CRA 2001; 62:4 Important Helsinki conference.
CRA 2001; 63:1 Declaration of Helsinki changes need clarification.
CRA 2001; 63:5 Do you have any questions on Declaration of Helsinki interpretation.
CRA 2001; 65:6 Old Helsinki referred to in Directive.
CRA 2001; 68:1 FDA has no requirement for Helsinki 2000.
CRA 2001; 68:2 Helsinki article 30 caused problems for trial sponsors.
CRA 2001; 68:3 Special report from Pretoria 2001 - interpreting and implementing Helsinki 2000.
CRA 2001; 71:1 WMA may be forced to change Helsinki 2000.
CRA 2001; 73:1 EMEA releases opinion on placebo trials.
CRA 2001; 73:4 EMEA/CPMP Position Statement on the use of placebo in clinical trials with regard to the revised Declaration of Helsinki.
CRA 2001; 79:1 WMA clarifies Helsinki placebo problem.
   
2000  
CRA 2000; 43:1 Comments invited on the Declaration of Helsinki.
CRA 2000; 48:6 Revision of the Declaration of Helsinki.
CRA 2000; 53:1 New draft of Declaration of Helsinki.
CRA 2000; 54:4 Declaration of Helsinki, Edinburgh 2000?
CRA 2000; 55:1 Final proposed Declaration of Helsinki prepared by workgroup.
CRA 2000; 55:5 Good Publication Practice.
CRA 2000; 55:sup Declaration of Helsinki: Edinburgh 2000.
CRA 2000; 56:1 New Declaration of Helsinki approved.
CRA 2000; 56:3 Use of placebo still major cause of ethical unrest.
   
1999  
CRA 1999; 29:1 New draft of Helsinki Declaration.
CRA 1999; 30:1 Comments invited on revision to Declaration of Helsinki.
CRA 1999; 30:3 Proposed Declaration of Helsinki.
CRA 1999; 37:1 Revising the Declaration of Helsinki: a fresh start.
CRA 1999; 39:1 Comments invited on changes to Declaration of Helsinki.
   
1998  
CRA 1998; 11:1 Declaration of Helsinki: more changes to come?
   
1997  
CRA 1997; 1:1 Declaration of Helsinki changed.

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