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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdDetailed Guidances
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 |
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2006 |
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CRA 2006; 169:2 |
EC issues revised Detailed Guidance on ethics committee applications. |
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CRA 2006; 170:1 |
Updated Detailed Guidance published on the collection and reporting of
adverse reactions. |
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CRA 2006; 170:1 |
European Commission, not EMEA. |
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CRA 2006; 171:2 |
Revised Detailed Guidance on adverse reactions. |
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2004 |
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CRA 2004; 131:1 |
Revised Detailed Guidances issued to support implementation of Directive
2001/20/EC. |
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CRA 2004; 131:2 |
Highlights of changes and new material in the April 2004 revision of the
Detailed Guidances. |
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CRA 2004; 137:1 |
The impact of EU Directive 2001/20/EC on commercial sponsors. |
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2003 |
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CRA 2003; 102:1 |
Detailed Guidances: no news yet. |
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CRA 2003; 104:1 |
Commission Directive to annex guidance. |
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CRA 2003; 110:1 |
EU releases final versions of five Detailed Guidance documents. |
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CRA 2003; 111:1 |
New SOPs required in order to comply with EU Detailed Guidance. |
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CRA 2003; 111:2 |
The Eudract database - a European register of clinical trials. |
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CRA 2003; 111:4 |
Application for Clinical Trial Authorisation. |
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CRA 2003; 111:6 |
Final Detailed Guidance on applications to Ethics Committees. |
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CRA 2003; 111:9 |
New guidance on safety reporting. |
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CRA 2003; 111:11 |
The European database of suspected unexpected serious adverse reactions
(Eudravigilance). |
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CRA 2003; 114:8 |
Commission Directive latest. |
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2002 |
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CRA 2002; 82:8 |
More on EU GCP Directive guidelines. |
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CRA 2002; 87:1 |
GCP Directive Guidelines on track for June. |
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CRA 2002; 89:66 |
First detailed guidelines to support 2001/20/EC Directive now publicly
available. |
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CRA 2002; 92:1 |
First Detailed Guidances to support implementation of GCP Directive
released. |
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CRA 2002; 92:2 |
Draft guidance on the Trial Master File and archiving. |
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CRA 2002; 92:4 |
Guidelines on the qualifications of GCP inspectors. |
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CRA 2002; 92:5 |
Procedures for the verification of GCP compliance. |
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CRA 2002; 93:1 |
New detailed guidelines from EC. |
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CRA 2002; 94:1 |
EU Detailed Guidances now publicly available. |
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CRA 2002; 94:1 |
New guidance on the principles of GCP in the conduct in the European
clinical trials. |
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CRA 2002; 94:2 |
Guidance for Ethics Committee applications. |
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CRA 2002; 94:5 |
The EUDRACT clinical trials database. |
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CRA 2002; 94:6 |
Detailed guidance on pre-trial authorisation. |
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CRA 2002; 94:7 |
Safety reporting and the SUSARs database. |
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CRA 2002; 96:1 |
EU Detailed Guidances subject to criticism. |
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CRA 2002; 97:1 |
Draft Detailed Guidance criticised. |
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CRA 2002; 97:1 |
Detailed Guidance requirements could force EU-destined research
elsewhere. |
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CRA 2002; 97:2 |
Application for Ethics Committee opinion. |
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CRA 2002; 97:3 |
The EUDRACT trials database. |
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CRA 2002; 97:4 |
Clinical trial authorisation. |
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CRA 2002; 97:5 |
Adhere to ICH GCP and make it plain!
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CRA 2002; 97:5 |
Safety reporting requirements: complications foreseen. |
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CRA 2002; 97:7 |
Three documents with the same reference number! |
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CRA 2002; 98:1 |
Serious reservations over EUDRACT. |
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CRA 2002; 99:8 |
New regulatory documents. |
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CRA 2002; 100:4 |
Current status of key European clinical research guidelines. |
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2001 |
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CRA 2001; 77:1 |
GCP Directive guidance awaited. |
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CRA 2001; 80:1 |
EU 'GCP Directive' - first draft guidance released for private
consultation. |