BRIDG Modeling Issue Discussion Study Protocol Version attributes

BRIDG Modeling Issue Discussion: Study. Protocol. Version attributes moving to Study or Study. Protocol 07/12/2016

Introduction • It has been suggested that it would be useful to have some of the key attributes currently located in Study. Protocol. Version promoted up to the Study or Study. Protocol level. • The rationale for having the attributes in Study. Protocol. Version is that virtually any characteristic of the protocol can change and trigger a new version of the protocol during the protocol development process. • While this rationale hasn’t really be contradicted and still holds true, it may be useful to have some key attributes available at a higher level for filtering and distinguishing between studies//protocols. • Proposal: Identify a small set of key attributes and add them as DERIVED attributes in Study/Study. Protocol, with the derivation being that they are drawn from the existing attributes (unchanged) in the most recent Study. Protocol. Version. • Questions for discussion on next slide

Questions for discussion 1. Agree to the proposal of adding derived attributes and leaving existing attributes as is in support of current use cases of protocol development? 2. Is Study the right class to denormalize the derived attributes into or should we put them in Study. Protocol? 3. What attributes are needed in Study/Study. Protocol? (see next slide for quick reference) 4. Are there other characteristics needed to copy to Study/Study. Protocol from other locations in the model?

Study. Protocol. Version Attributes • • • • 4 acronym mandatory. Indicator amendment. Grace. Period phase. Code primary. Purpose. Type. Code purpose. Statement target. Anatomic. Site. Code study. Schematic design. Configuration. Code adaptive. Design. Indicator companion. Code therapeutic. Area. Code study. Subject. Type. Code population. Description planned. Study. Subject. Experience • • • • planned. Site. Number. Range planned. Duration planned. Investigational. Exposure. Quotient target. Accrual. Number. Rnage periodic. Target. Accrual. Number accrual. Reporting. Method. Code responsible. Party. Code multi. Institution. Indicator participating. Organization. Type. Code ae. Coding. System condition. Coding. System delayed. Registry. Posting. Indicator data. Cutoff. Date