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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdGCP compliance and implementation
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:
Back to index |
| 2007 |
|
| CRA 2007; 187:4 |
BARQA to pilot a GCP inspection database. |
| CRA 2007; 192:6 |
Coordination of pre-approval GxP inspections. |
|
CRA 2007: 192:7 |
CDER issues new warnings to investigators. |
|
CRA 2007: 195:3 |
New MHRA guidance on responding to inspection findings. |
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| 2006 |
|
| CRA 2006; 169:1 |
Grey areas at GCP/GMP interface. |
| CRA 2006; 174:1 |
Russian GCP now in force. |
| CRA 2006; 175:3 |
Draft GCP guidelines published for Pan American region. |
| CRA 2006; 176:11 |
UK's GCP Consultative Committee meeting addresses concerns. |
| CRA 2006; 178:4 |
GCP principles: comparison between UK regulations and ICH GCP
guidelines. |
| CRA 2006; 179:7 |
Whistleblowing triggers for-cause inspections. |
| CRA 2006; 180:3 |
Protocol waivers in common use: is this wise? |
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| 2005 |
|
| CRA 2005; 144:4 |
European Directives affecting clinical trials in 2005: an overview. |
| CRA 2005; 145:1 |
European Commission issues Q&A document on implementing GCP
requirements in Europe. |
| CRA 2005; 149:1 |
European Commission Directive on GCP 2005/28/EC now published. |
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| 2004 |
|
| CRA 2004; 123:7 |
Further guidance to support Directive 2001/20/EC implementation. |
| CRA 2004; 123:7 |
UK Department of Health enters into joint project with MRC to meet
needs of Directive 2001/20/EC. |
| CRA 2004; 129:5 |
Making your sites suitable for trials: documents and filing. |
| CRA 2004; 133:6 |
FDA to revise regulations on foreign studies. |
| CRA 2004; 135:1 |
Long-awaited Commission Directive on GCP released for consultation. |
| CRA 2004; 141:6 |
India announces legislation to make GCP compliance mandatory. |
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| 2003 |
|
| CRA 2003; 103:1 |
Scope of WHO GCP Guidelines widened in new revision. |
| CRA 2003; 105:4 |
GCP guidelines: a new Directive. |
| CRA 2003; 107:1 |
UK releases proposals for new clinical trial regulations. |
| CRA 2003; 108:2 |
Industry warns European Parliament of major concerns with GCP
Directive. |
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| 2002 |
|
| CRA 2002; 82:5 |
The impact and consequences of protocol violations. |
| CRA 2002; 89:4 |
Version control vital to ensure GCP compliance. |
| CRA 2002; 92:5 |
Procedures for the verification of GCP compliance. |
| CRA 2002; 93:8 |
MCA not to inspect Ethics Committees. |
| CRA 2002; 94:1 |
New guidance on the principles of GCP in the conduct in the European
clinical trials. |
| CRA 2002; 97:5 |
Adhere to ICH GCP and make it plain! |
| CRA 2002; 100:4 |
Current status of key European clinical research guidelines. |
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| 2001 |
|
| CRA 2001; 67:4 |
Solutions to common GCP problems? |
| CRA 2001; 75:4 |
Sponsor or not a sponsor? |
| CRA 2001; 76:3 |
WHO guidelines on good clinical practice reviewed. |
| CRA 2001; 77:4 |
Archiving on CD-ROM. |
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| 2000 |
|
| CRA 2000; 43:5 |
GCP question on code breaking. |
| CRA 2000; 48:1 |
Poor GCP compliance by investigator is still major source of concern.
|
| CRA 2000; 49:6 |
Research law in Finland. |
| CRA 2000; 53:6 |
GCP in Australia. |
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| 1999 |
|
| CRA 1999; 20:2 |
New clinical research legislation in the Slovak Republic. |
| CRA 1999; 25:4 |
GCP implementation problems. |
| CRA 1999; 26:4 |
GCP implementation problems. |
| CRA 1999; 28:3 |
GCP implementation problems. |
| CRA 1999; 29:2 |
GCP and the use of electronic communications. |
| CRA 1999; 30:2 |
Compliance with GCP. |
| CRA 1999; 32:6 |
ICH GCP complicates trials in Japan. |
| CRA 1999; 35:2 |
Is full GCP necessary in Phase IV? |
| CRA 1999; 36:5 |
Trials to be conducted to ICH GCP in Poland. |
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| 1998 |
|
| CRA 1998; 3:1 |
Retrospective GCP compliance dangerous. |
| CRA 1998; 4:5 |
GCP compliance begins in Japan. |
| CRA 1998; 5:3 |
GCP compliance problems in the Netherlands. |
| CRA 1998; 6:1 |
ICH GCP becomes a legal requirement in the Netherlands. |
| CRA 1998; 7:5 |
GCP in Argentina. |
| CRA 1998; 8:1 |
Adoption of EU GCP Directive hindered by delays. |
| CRA 1998; 8:2 |
Academic units may have problems with EU GCP Directive. |
| CRA 1998; 8:6 |
MRC introduces more guidelines on GCP. |
| CRA 1998; 12:1 |
Poor levels of GCP compliance by investigators. |
| CRA 1998; 13:6 |
ICH GCP now law in Italy. |
| CRA 1998; 15:4 |
Multinational, multicentre studies: the pros and cons. |
| CRA 1998; 18:3 |
GCP deficiencies in CEE and Western Europe. |
| CRA 1998; 18:4 |
Detecting consent problems in the Slovak Republic. |
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| 1997 |
|
| CRA 1997; 1:1 |
Draft EU Directive on GCP now with European Parliament. |