This Technical Report is structured around four review areas: — stakeholder groups concerned with the work of TC 215; — potential benefits/outcomes of clinical stakeholder participation; — current nature of stakeholder participation; — recommendations for improving clinical stakeholder participation. The review is limited to clinical stakeholder groups. Stakeholders from industry, consumer groups and other non-clinical groups are outside the scope of this Technical Report, as are the specific issues related to participation of clinical stakeholders in developing countries. The content of this Technical Report is based on informal consultation among delegates attending TC 215 meetings and e-mail communication with interested individuals. Opportunities to comment on the draft report were provided prior to and during the 2007 Montreal plenary meeting in accordance with the TC Resolution at the 2006 Jeju plenary. The purposes of this Technical Report are: a) to clarify and confirm TC 215 support for clinical stakeholder participation; b) to make recommendations to the TC and to national member organizations on approaches to improving clinical stakeholder participation based on examples of existing effective participation models.