Process

A. Selection of topic    AEFI Prioritization   Based on severity, frequency of reporting, enhanced public interest and emerging scientific needs.   Methodological topic   Based on priority of methodological questions from Case Definition development and evaluation.   B. Formation of Working Groups *   Call for volunteers   Announcement for formation of Working Groups via publications, presentations, «Brighton» website and email list, and referrals.   Composition of groups   Based on interest of volunteers and balanced composition of professional expertise and geographical location.   C. Exploratory review    Inventory   Systematic search and compilation of published and unpublished definitions and guidelines.   Assessment    Evaluation of inventory through discussions by the Working Group.   D. Development of draft Case Definition document   Consensus   A draft document is developed based on the exploratory review and group consensus.   E. Formation of Reference Group  * Identification and enlistment of participants   Organizations and individuals with experience in immunization safety assessment and medical expertise are contacted to participate in evaluation and implementation of «Brighton» Case Definitions and Guidelines. Survey   Draft documents are posted on the «Brighton» website together with a survey. Reference Group participants are alerted to the survey via the «Brighton» email list (brightonlist@brightoncollaboration.org).   F. Revision   Survey analysis   Survey data are compiled and discussed by the Working Groups.   Adjustment   Draft documents are adjusted taking survey data into account.    G. Finalization of «Brighton» documents   Consensus   «Brighton» documents are finalized based on consensus in the respective Working Groups, and in harmonization with other «Brighton» documents.   H. Maintenance    Cyclical revision   Cyclical revision will occur based on new information from implementation of «Brighton» documents in clinical pre-licensure and post-licensure vaccine safety trials, surveillance systems, and from other sources including a formal review by the WHO|CIOMS Vaccine Pharmacovigilance Working Group.     Footnote* Footnote*: At these steps, members of the WHO|Council for International Organisations of Medical Sciences (CIOMS) Vaccine Pharmacovigilance Working Group are particularly encouraged to participate. Click here for more information on the CIOMS Vaccine Working Group

A. Identification and enlistment of users  Organizations and individuals with use for case definition documents are contacted to create a global implementation network.  B. Information  Users are informed about the benefit of using «Brighton» documents.  C. Dissemination  All «Brighton» documents will be made easily accessible via this website and other means of distribution.  D. Implementation  Endorsement and global acceptance of «Brighton» documents will be sought.  E. Monitoring  The extent of use of «Brighton» documents worldwide will be monitored.

Evaluation Studies Assessment of applicability, reliability, sensitivity and specificity of case definitions, and applicability and usefulness of guidelines in clinical pre- and post-licensure vaccine safety trials and post-marketing surveillance systems. Field use Assessment of day-to-day applicability and usefulness of «Brighton» documents in different settings. Outcome evaluation Monitoring and assessment of impact of standardization of case definitions and guidelines