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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdPatient protection
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 |
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CRA 2007; 187:6 |
CDER warning letters highlight investigator failings. |
|
CRA 2007; 188:6 |
Prisoner research in the USA. |
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CRA 2007; 188:7 |
IRB fails to provide adequate subject protection. |
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CRA 2007; 190:8 |
New report on protecting subjects. |
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| 2006 |
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CRA 2006; 168:2 |
TeGenero monoclonal antibody causes shock side-effects in UK trial. |
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CRA 2006; 174:2 |
No compensation for injured research subjects in the USA? |
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CRA 2006; 174:3 |
New FDA initiative aims to modernise clinical trial regulation and
bioresearch monitoring. |
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| 2005 |
|
| CRA 2005; 144:7 |
Problems with Cox-2s cause public alarm. |
| CRA 2005; 151:1 |
FDA inspector unimpressed by explanation for serious trial violations. |
| CRA 2005; 155:2 |
Inspection reveals trial commenced without IND. |
| CRA 2005; 156:8 |
Common rule amendments. |
|
CRA 2005; 160:4 |
Identifying the most frequent violations of FDA regulations. |
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| 2004 |
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| CRA 2004; 123:3 |
Improving best practices: FDA warnings to sponsors reveal significant
defects. |
| CRA 2004; 132:3 |
New guidance to protect trial subjects from financial conflicts of
interest. |
| CRA 2004; 133:1 |
What is the impact of EU Directive 2001/20/EC on clinical research? |
| CRA 2004; 137:11 |
WMA supports smoke-free public places. |
| CRA 2004; 138:1 |
US guidance on the use of clinical holds following misconduct at site. |
| CRA 2004; 138:2 |
How to comply with the 'Common Rule' - or not as the case may be! |
| CRA 2004; 138:8 |
DIA identifies key issues for subject protection. |
| CRA 2004; 140:3 |
The use of clinical holds following investigator misconduct. |
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| 2003 |
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| CRA 2003; 108:1 |
US proposes new guidance for financial conflicts of interest in human
subject research. |
| CRA 2003; 113:2 |
Shake up for Veterans Affairs research. |
| CRA 2003; 117:6 |
Veterans Affairs developments. |
| CRA 2003; 119:2 |
Human subject protection regulations and the 'Common Rule'. |
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| 2002 |
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| CRA 2002; 82:1 |
FDA detachment may harm subjects in foreign trials. |
| CRA 2002; 85:6 |
Consortium for subject protection. |
| CRA 2002; 96:1 |
New final version of US 'Privacy Rule'. |
| CRA 2002; 96:2 |
How US 'Privacy Rule' affects industry sponsors. |
| CRA 2002; 99:2 |
New approaches to subject protection in USA. |
| CRA 2002; 99:6 |
Crisis management. |
| CRA 2002; 100:6 |
An overview of US regulations contained in the Code of Federal
Regulations. |
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| 2001 |
|
| CRA 2001; 62:1 |
Does a patient always get the best proven treatment? |
| CRA 2001; 63:4 |
Patient protection procedures to be revised. |
| CRA 2001; 67:3 |
Early termination of studies may harm subjects. |
| CRA 2001; 68:2 |
Helsinki article 30 caused problems for trial sponsors. |
| CRA 2001; 80:8 |
National award program to promote subject protection. |
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| 2000 |
|
| CRA 2000; 51:6 |
New patient protection strategies in USA. |
| CRA 2000; 53:2 |
Content of the latest draft of the Directive on GCP in Clinical
Trials. |
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| 1999 |
|
| CRA 1999; 24:5 |
Member States must define protection for vulnerable subjects. |
| CRA 1999; 24:6 |
Extension for Ethics Committee review to be reduced from 30 to 15
days? (Subject protection in trials stopped early.) |
| CRA 1999; 32:1 |
Compensation rights - are patients aware? |
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| 1998 |
|
| CRA 1998; 8:1 |
Patients will need independent trial information. |