1. CRI Working Group Meeting Thursday, March 21, 6 p.m. to 7:30 p.m. in room Cyril Magnin I Immediately following the reception

2. Agenda Introduction and welcomeUmberto Tachinardi CRI WG activity and plans for 2013Umberto Tachinardi Topics from previous CRI meetings Additional topics, leadership, team members Should the CRI WG meeting be at TBI/CRI or the Fall meeting? Update on CRI Competency projectMeredith Nahm SCDM Draft definition of profession Meredith Nahm Nominations Umberto Tachinardi

3. CRI-wg Previous Project Topics CRI education competencies (ongoing) CRI focused policy recommendations (IT/Informatics/Data Governance Inventory?, security?) Best practices for multi-site study data coordinating centers (merge with the above?) Webinars w/ partner organizations and other opportunities for ongoing education Global directions for CRI engagement in the global public health agenda Leadership and team members – any takers ? New additions ?

4. Clinical Research Professional Competencies Project Project Team: Meredith Nahm, PhD Project Coordinator (Duke), Rachel Richesson, PhD (Duke), Renee Pridgen (Duke), Judy Logan, MD, MS (OHSU), Umberto Tachinardi, MD‎ (UW), Chris St Clair (Medstar HRI)

5. Goal & Objective Both industry and academia indicate a need for qualified CRI professionals. The CRI Working Group would like to respond to this need by performing a rigorous competency analysis of CRI groups in academia and industry. Goal: To inform position description and curriculum development in clinical research informatics Objective: To rigorously develop a set of consensus competencies for masters-level CRI professionals

6. Foundation to Build on (AMIA CRI Working Group, later augmented by Embi and Payne 2009) Evaluation and modeling of clinical and translational research workflow Social and behavioral studies involving clinical research professionals and participants Designing optimal human-computer interaction models for clinical research applications Improving information capture and data flow in clinical research Optimizing site selection, investigator and subject recruitment Knowledge engineering and standards development as applied to clinical research Development and evaluation of standardized approaches to research data management and dissemination Facilitating and improving research reporting to regulatory agencies Enhancing clinical and research data mining, integration, and analysis Integrating research findings into individual and population level health care Knowledge integration across clinical and research information systems Defining and promoting ethical standards in CRI practice Educating researchers, informaticians, and organizational leaders about CRI Driving public policy around clinical and translational research informatics

7. Initial Look-see Mapped course offerings from 4 HI programs to SCDM task list, presented at 2011 meeting Conclusions –Common BMI/HI Curriculum is a great foundation –Four main gaps Introduction to Clinical Research Clinical Research Data Management &Information Systems Clinical Research Workflow Analysis and Design

8. Design DACUM (developing a curriculum)-style set of focus groups –conducted at three institutions with active CRI (ARO, a CRO, a Pharmaceutical company) –Injected into round two of Delphi Four round Delphi process

9. Status Obtained commitment of support from Duke CTSA to handle IRB submission, software config., and Delphi administration Meeting tomorrow with AMIA leadership about project in preparation for Board review Need to cover travel for 2 DACUMs and refreshments.

10. Other Business ?

11. Thank you and Have a Great Rest of the Conference !!