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A newsletter for those involved in clinical trials. Published 20 times a year by Canary Ltd
Informed consent
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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2007 |
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CRA 2007; 183:1 |
UK Clinical Trials Regulations amended for emergency research. |
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CRA 2007; 184:8 |
Consent in emergency research. |
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CRA 2007; 185:6 |
Guidance on consent and information sheets. |
| CRA 2007; 193:2 |
ABPI issues guidelines on secondary use of data for
research. |
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2006 |
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CRA 2006; 166:5 |
Warning letters pick up more consent violations. |
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CRA 2006; 167:2 |
Standard clauses for data transfer are underused says EC report. |
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CRA 2006; 167:5 |
Do subjects really understand consent forms? |
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CRA 2006; 167:8 |
Model wording for consent forms. |
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CRA 2006; 169:2 |
EC issues revised Detailed Guidance on ethics committee applications. |
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CRA 2006; 170:6 |
Focusing on the subject in informed consent. |
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CRA 2006; 171:5 |
IRBs violate FDA regulations. |
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CRA 2006; 171:8 |
Parents and paediatric research. |
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CRA 2006; 172:3 |
FDA uncovers violations of regulations: consent deficiencies predominate. |
| CRA 2006; 172:8 |
FDA enforcement discretion. |
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CRA 2006; 179:5 |
A positive approach to paediatric informed consent. |
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CRA 2006; 180:4 |
CDRH inspections lead to new investigator warning letters. |
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CRA 2006; 181:8 |
Consent in emergency research. |
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2005 |
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CRA 2005; 146:7 |
Readability of trial documents. |
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CRA 2005; 148:3 |
Violation of consent puts patients at risk. |
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CRA 2005; 148:4 |
Amendment to UK trials legislation to enable studies in emergency
medicine. |
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CRA 2005; 150:6 |
Investigator fails to impress inspectors. |
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CRA 2005; 152:5 |
Warning letter criticises consent documents. |
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CRA 2005; 155:2 |
Inspection reveals trial commenced without IND. |
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CRA 2005; 156:1 |
UK proposes amendment to clinical trials regulations. |
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CRA 2005; 160:4 |
Identifying the most frequent violations of FDA regulations. |
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CRA 2005; 161:6 |
CDRH issues more investigator warning letters. |
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2004 |
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CRA 2004; 132:3 |
Lessons to learn as jury clears cancer centre. |
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CRA 2004; 133:1 |
What is the impact of EU Directive 2001/20/EC on clinical research? |
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2003 |
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CRA 2003; 109:2 |
UK Department of Health seeks comments on procedures for informed
consent. |
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CRA 2003; 112:7 |
Can technology enhance the consent process? |
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CRA 2003; 113:8 |
UK plans for legal representative. |
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CRA 2003; 114:1 |
UK publishes draft proposals on consent from legal representatives. |
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2002 |
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CRA 2002; 84:1 |
Warning of increase in law suits from subjects. |
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CRA 2002; 86:2 |
Consent by legally authorised representative must be lawful. |
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CRA 2002; 86:2
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ICH GCP has improved trial quality in Europe - but safety reporting in
the US is a cause for concern. |
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CRA 2002; 94:2 |
Guidance for Ethics Committee applications. |
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CRA 2002; 95:1
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Call for amendment of Directive 2001/20/EC over emergency research. |
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CRA 2002; 98:1 |
Cancer centre damages. |
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2001 |
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CRA 2001; 65:4 |
Directive makes consent an important process. |
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CRA 2001; 66:5 |
Do consenting subjects really understand? |
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CRA 2001; 67:6 |
Consent forms and financial disclosure. |
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2000 |
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CRA 2000; 41:5 |
US guidance for research in mental disorders.
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CRA 2000; 47:1 |
Guidelines for academic trials?
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CRA 2000; 50:1 |
New Scottish Law on adults with incapacity.
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1999 |
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CRA 1999; 19:4 |
US moves towards a consent form template.
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CRA 1999; 20:1 |
Six-day consent rule is obligatory in Ireland.
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CRA 1999; 20:1 |
Do your informed consent forms pass the NCI test?
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CRA 1999; 24:3 |
Informed consent defined.
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CRA 1999; 24:4 |
Consent elements tightened up in amended Directive?
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CRA 1999; 24:5 |
Member States must define protection for vulnerable subjects.
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CRA 1999; 26:4 |
Written informed consent now required in Japan.
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CRA 1999; 27:3
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Guidelines for researchers – patient information sheet and consent form.
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CRA 1999; 29:4 |
Declaration of Ottawa protects children.
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CRA 1999; 30:5 |
Additional requirements for informed consent.
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CRA 1999; 31:6 |
Six-day consent rule in Ireland.
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CRA 1999; 34:1 |
Consent forms forged?
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1998 |
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CRA 1998; 3:3 |
Is delegation of consent acceptable?
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CRA 1998; 6:2 |
Guidance on patient information and consent forms.
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CRA 1998; 6:5 |
Protecting women in trials.
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CRA 1998; 18:4 |
Detecting consent problems in the Slovak Republic.
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