1 / 5

Protocol Representation

This project aims to develop a standard model for clinical trial protocol representation to enhance study design, regulatory compliance, and data interchange among stakeholders. The project will identify and codify protocol elements based on consumer needs. Interim objectives include developing a comprehensive list, recruiting participants, and proposing initial and subsequent models. The project involves various tasks such as sorting, organizing, and harmonizing elements. Communications will be facilitated through HL7, CDISC, RCRIM website, conference calls, and meetings. Leaders: Katherine Hollinger, Carol Broverman, Rebecca Kush.

leannel
Download Presentation

Protocol Representation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Protocol Representation HL7 RCRIM Technical Committee Project

  2. 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.

  3. 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

  4. 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 participants @ DIA – 17-19 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)

  5. 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

More Related