European Clinical Research Infrastructures Network (ECRIN) - transnational working groups (TWG) - 2008 reports:

  • Deliverable 1 - Securing participant’s autonomy and interacting with ethics committees. View.
  • Deliverable 2 - Clinical Research in Europe: interaction with ethics committees before, during and after a clinical trial. View.
  • Deliverable 3 - Potential publications. View.
  • Deliverable 4 - Clinical research in Europe: national differences in legislative and regulatory frameworks. View.
  • Deliverable 5 - Meetings on the legislative and regulatory frameworks for clinical research in Europe. View.
  • Deliverable 6 - Regulatory requirements for adverse reporting in ECRIN countries. View.
  • Deliverable 7 - Establishment of network for the development of EU-wide postmarketing surveillance studies. View.
  • Deliverable 8 - A report on the computerization of adverse event reporting. View.
  • Deliverable 9 - Survey on data management, tools and procedures within ECRIN. View.
  • Deliverable 10 - GCP-compliant data management in multinational clinical trials. View.
  • Deliverable 11 - Identification, evaluation and prioritization of possible common or compatible GCP-compliant data management tools for multinational trials. View.
  • Deliverable 12 - Survey on existing strategies for monitoring and risk definition. View.
  • Deliverable 13-14 - Development of a risk assessment tool, assessment of its reliability and definition of a common monitoring strategy and report. View.
  • Deliverable 15 - Specification of quality based Standard Operating Procedures design to address the issues and needs of transnational projects. View.
  • Deliverable 16 - Standard Operating Procedure Development, review, approval and management of SOPs. View.
  • Deliverable 17 - Final report on quality assurance. View.
  • Deliverable 18 - Standard Operating Procedures on Ethics. View.
  • Deliverable 19 - Standard Operating Procedures on Regulation and interaction with competent authorities. View.
  • Deliverable 20 - Standard Operating Procedures on adverse event reporting. View.
  • Deliverable 21 - Standard Operating Procedures on monitoring. View.
  • Deliverable 22 - National reports for new networks connecting to ECRIN. View.
  • Deliverable 23 - ECRIN Website (www.ecrin.org). View.
  • Deliverable 24 - Survey on existing education programmes within the ECRIN member states. View.
  • Deliverable 25-26 - Material for European and national educational programs. View.