The second Edition of Part 1 of the NIS Reports was released yesterday (24th August 2010).

The report is now more comprehensive and includes:

• Data Protection: Information on the country-specific Data Protection Agencies and data protection requirements
• Service Providers: Information about, and links to, companies and organisatopns who specialise in the conduct and management of NIS
  
• Country-Specific Information: The country-specific information has been updated to reflect the changes over the past year.  In particular, the information for Spain has been extensively updated.
  

The report has been emailed, free of charge, to all who have previoulsy purchased a copy.  If you haven't received your copy, please contact me at stuart.mccully@chcuk.co.uk as soon as possible.
 

BfArM and the PEI released the latest version of the joint "Recommendation on the Planning, Implementation and Evaluation of Observational Studies" on the 7th July 2010.

The latest document is split into the following sections:

• Preamble
• Definitions
  
• Application Observations (AWB)
• Non-Intervention
• Monitoring and Evaluation Plan
• General Requirements for Observational Studies
  
• Goals of Observational Studies
• Quality Assurance
• Patient Information and Consent
• Conflicts of Interest and Ethics
• Display and Reporting Requirements
• Reporting and Archiving
• Reimbursement and Remuneration
  

Section 1.2 provides clarification on the use of questionnaires in an observational study.

Please note that this document is in German.