Protocol Representation HL7 RCRIM Technical Committee Project

Project Scope Statement: Project Description Protocol Representation will identify standard elements of a clinical trial protocol that can be further elucidated and codified to facilitate study design, regulatory compliance, project management, trial conduct and data interchange among consumers and systems. This work will be based upon the needs of protocol consumers, which may include regulatory authorities, IRBs, statisticians, project managers, site personnel and users of any downstream systems for the management of clinical trial information.

Project Scope Statement: Objective, Leaders Project Objective(s): Publication of a standard model for protocol representation that will facilitate interchange of this data among systems and stakeholders Co-Leaders: Katherine Hollinger, Carol Broverman, Rebecca Kush

Interim Objectives (Tasks) – Develop an initial list (SDS team, PR group, KH) – 3 May – Sort and organize into logical headings (eliminate redundancy and include informal input) – end May – Harmonize with SDS on protocol elements section – end May – Revise, integrate into exhaustive list; headers –10 June – Develop form to enlist interested parties – 10 June – Recruit additional DIA – June – Obtain more formal input from consumers – end July – Identify core/non-core elements,define and propose choice lists – Propose initial model – September 17 (DIA Standards Workshop) – Propose next iteration of model in October (HL7 WGM)

Communications List server through HL7 Notify of existence (CDISC, RCRIM website) Conference calls Interim meeting and recruitment of additional participants (June DIA and TACTICS SIAC) Meeting prior to Sept. DIA Standards Workshop in Bethesda Baltimore HL7 Working Group Meetings