1. Pediatric Terminology Harmonization Initiative Introduction October2014 National Cancer Institute EVS

2. Project Goal NICHD and the National Children’s Study Goal: Improve the health of children by gaining a better understanding of the influence of various factors on child health and disease. Pediatric Research Terminology Project Goal: Establish a set of harmonized pediatric terms that will help to standardize variables and datasets in pediatric clinical research, safety and quality reporting.

3. Pediatric Terminology Collaboration

4. Collaboration Overview (link)link

5. The Team Working Group Lead: Dr. Charmian Quigley Subject Matter Experts : Individuals knowledgeable in the area of interest willing to share their knowledge, experiences and working group meetings. Terminology Experts : Individuals with a clinical or biomedical background and experience in developing and modeling terminologies for clinical/biomedical research.

6. Working Group Lead Responsibilities Working Group Lead Query associations or professional groups to solicit for subject matter expert candidates Query associates that may be interested in participating Query NICHD Governance for any SME candidates Sends out letter of invitation to SME candidates (EVS can provide a draft) Directs flow of conversation during meetings, facilitates consensus regarding terms and definitions

7. Subject Matter Expert Responsibilities SMEs Review material for weekly web conferences Contribute their expertise to term and definition development Participate in one hour weekly teleconferences OR Review material weekly and submit comments via email

8. Terminology Experts Responsibilities EVS Track SME acceptances, send introduction packages Poll WG members for common working group time Send meeting invites, arrange web & teleconferences Prepare starter set of terminology, research and draft definitions Scribe during meetings, maintain terminology worksheet

9. Working Group Meeting Define scope of work Evaluate Terms and Definitions Think about any potential gaps or other sources of terms Review placement of terms in Hierarchy

10. Brief Process Input Analysis -Gather lists, forms, suggestions Terminology Gap Analysis -Map potential candidates against existing terminologies New Subset/Term Development/Add Metadata -Develop and define unmapped terms Review -Review data for public release Publication -Publish data Ongoing QA Processes -Address Change Requests

11. Contact Information Dr. Charmian Quigley Volunteer Associate Professor Indiana University School of Medicine CharmianQ@gmail.com Margaret Haber Program Manager Enterprise Vocabulary Services National Cancer Institute mhaber@mail.nih.gov Theresa Quinn Biomedical/Clinical Research Information Specialist (C) Enterprise Vocabulary Services National Cancer Institute quinnt@mail.nih.gov