Mandate

• To develop a code of conduct governing the responsibilities and interaction of stakeholders (industry, research centres, regulators, etc) in the conduct of PhV studies in order to ensure scientific independence and transparency, including:
  - Data ownership: raw data, analysed data
  - Centres' right/commitment to submit for publication
  - Centres' and MAHs'obligation to follow transparency rules
  - Authorships
  - Funders or sponsors' rights: observer/presence in steering groups, information and comments on reports and manuscripts, time limits for comments, etc.
  - Regulatory requirements for reporting; interventional and non-interventional studies
  - Rules for financial interactions
  - Liability issues
  - Mandatory elements for standard contracts and legal issues (e.g. legislation under which study is carried out, copyright)
  - Introduce Annex with sample/template contract
  - protocol agreement, reporting of results, etc.
  - Define milestones when information details of a PhEpi study in progress shall be made available, or public, to stakeholders
  - Elaborate approaches/ways to ensure transparency, e.g. web-publication of the research protocol and/or the study results, etc.
  - Ensure transparency translates into effective public communication (e.g. on future European Medicines Agency Safety Portal)
  - Develop training programs
  
  
• Register of non-interventional PhEpi safety studies: develop a draft paper addressing the appropriateness, feasibility, scope and framework. Start with ENCePP studies
  - Elaborate approaches for establishment of a register of initiated and conducted studies through ENCePP
  - Define rules for the access of third parties to research data in the register
  - Develop a proposal for standard forms for website publication and entries in the register.