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

Data protection and confidentiality

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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2007
CRA 2007; 193:2 ABPI issues guidelines on secondary use of data for research.
CRA 2007; 193:8 Data protection breaches in UK.
2006
CRA 2006; 163:7 Clinical research and the HIPAA Privacy Rule.
CRA 2006; 163:10 Privacy rights in Italy a hot topic.
CRA 2006; 167:2 Standard clauses for data transfer are underused says EC report.
CRA 2006; 167:8 Model wording for consent forms.
CRA 2006; 178:1 Good storage practice for specialised biological samples.
CRA 2006; 180:7 UK Information Commissioner offers 'good data protection practice' advice.
CRA 2006; 182:10 Good storage practice for specialised biological samples.
2005
CRA 2005  144:8 New FOI Act in the UK.
CRA 2005  145:4 Is the Swedish Act on biobanks in medical care applicable to clinical trials?
CRA 2005  148:1 US 'Privacy Rule' becomes legally enforceable.
2003
CRA 2003: 102:3 Transfer of personal data without specific subject consent.
CRA 2003  109:1 New US medical privacy regulations have come into force: HHS statement.
CRA 2003  110:4 Guidance issued to researchers on the US Privacy Rule (HIPAA).
CRA 2003  110:4 Privacy legislation lags behind science.
CRA 2003  120:7 Misinformation still surrounds HIPAA.
CRA 2003  121:2 The challenge of complying with US data privacy requirements.
2002
CRA 2002  83:1 Data transfer contracts.
CRA 2002  83:2 Sponsor staff may risk prosecution for non-compliance with data transfer requirements.
CRA 2002  85:4 Just what or who is a Data Processor?
CRA 2002  88:2 Transfers of data outside Europe.
CRA 2002  94:2 Guidance for Ethics Committee applications.
CRA 2002  96:1 New final version of US 'Privacy Rule'.
CRA 2002  96:2 How US 'Privacy Rule' affects industry sponsors.
CRA 2002  96:6 Health and Social Care Act raises concern over patient confidentiality.
CRA 2002  100:4 Current status of key European clinical research guidelines.
2001
CRA 2001  60:2 Implementation of the Data Protection Directive.
CRA 2001  67:2 Proposal to extend data transfer outside the EU.
CRA 2001  67:6 ABPI oppose Government Health and Social Care Bill.
CRA 2001  71:3 EU Data Protection Directive and its implementation in Italy.
CRA 2001  71:4 Data protection inadequately addressed in UK's new patient information guidelines.
CRA 2001  72:8 EU data protection: approved countries.
CRA 2001  73:1 Standard clauses for data protection.
CRA 2001  73:6 Luxembourg face EU action for lack of data protection.
CRA 2001  75:2 Data protection - still unresolved issues.
CRA 2001  75:3 Draft Guidance: use and disclosure of medical data.
CRA 2001  75:6 Denmark requires data protection approval for trials.
CRA 2001  78:4 Data protection - are you ready for the new law?
CRA 2001  79:2 Information Commissioner's guidance on uses and disclosure of medical data: report on Commissioner's 'Consultation Day'.
2000
CRA 2000  40:6 New data protection law.
CRA 2000  41:1 Can trial data be sent to the FDA?
CRA 2000  41:3 Explicit consent may avoid data problems.
CRA 2000  41:6 High court ruling allows industry access to anonymised data.
CRA 2000  44:1 Data transfer to US will breach law.
CRA 2000  49:2 What you need to know about data protection and clinical research (part 1).
CRA 2000  49:6 Protection of product data to be harmonised.
CRA 2000  50:2 Data protection in clinical research (part 2).
CRA 2000  51:2 Data protection in clinical research (part 3).
CRA 2000  52:3 Data protection in clinical research (part 4).
CRA 2000  54:1 ‘Safe harbor’ principle agreed.
CRA 2000  54:1 Data transfer to Switzerland and Hungary acceptable.
1999
CRA 1999  24:3 Proposed database for completed trials only?
CRA 1999  30:5 Exchange of information.
CRA 1999  35:1 Data protection Directive does effect clinical research.
CRA 1999  35:4 Personal identity numbers?
CRA 1999  39:1 New data protection law may affect PMS studies.
1998
CRA 1998  7:1 Dire consequences of breaching confidentiality.
CRA 1998  8:5 Concern about patient confidentiality in France.
CRA 1998  11:1 Are you ready for the Data Privacy Directive?

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