Overview Data Coordinator Training Year 2, Meeting 1 December 6-9, 2005 Yvette Roubideaux, MD, MPH

Data Coordinator Training – October Meeting Overview – Data Collection Plan Overview – Data Collection Plan Data Collection Process – detailed review Data Collection Process – detailed review Screening and Recruitment Screening and Recruitment Baseline Assessment of Core Elements Baseline Assessment of Core Elements Baseline Questionnaires (Participant, Family) Baseline Questionnaires (Participant, Family) Process Evaluation Forms (Intensive Activities) Process Evaluation Forms (Intensive Activities) Preview – Follow-up, Annual, Provider, Community Forms and Questionnaires (December Meeting) Preview – Follow-up, Annual, Provider, Community Forms and Questionnaires (December Meeting) Data Collection Procedures Data Collection Procedures Informed Consent/HIPAA Authorization Informed Consent/HIPAA Authorization Data Quality Control Data Quality Control Safety Reporting Safety Reporting Getting Organized Getting Organized

CGP Operations Manual Purpose: Reference for Data Collection Process Purpose: Reference for Data Collection Process Contents: Contents: SDPI CGP Overview SDPI CGP Overview CGP Core Elements CGP Core Elements Evaluation in AIAN Communities Evaluation in AIAN Communities Data Collection Process (Steps) Data Collection Process (Steps) Data Collection Guidelines Data Collection Guidelines Appendix Appendix Forms, Questionnaires, Instructions Forms, Questionnaires, Instructions Reference Materials Reference Materials Version 1.0 Version 1.0

Introduction to Data Core Staff Coordinating Center Data Coordinators Coordinating Center Data Coordinators Healthy Heart Project Healthy Heart Project Jeanne Amos Jeanne Amos Diabetes Prevention Program Diabetes Prevention Program Karen Rogers Karen Rogers Coordinating Center Information Technology Core Coordinating Center Information Technology Core Registry Registry Greg Schaffer, IT Manager Greg Schaffer, IT Manager Ry Mittlestadt, Web Developer Ry Mittlestadt, Web Developer IRB/HIPAA Authorization IRB/HIPAA Authorization Timothy Noe M Div Timothy Noe M Div

Since the last meeting… Reviewed input, evaluations Reviewed input, evaluations Answered questions from meeting Answered questions from meeting Revised forms, questionnaires to their final form Revised forms, questionnaires to their final form Final formatting of forms/questionnaires Final formatting of forms/questionnaires Operations Manual – Version 2.0 Operations Manual – Version 2.0 Updated with new forms, text Updated with new forms, text Developed interactive sessions for this meeting Developed interactive sessions for this meeting Includes new worksheets, reference information Includes new worksheets, reference information

Data Coordinator Training – December 2005 Focus of meeting: Focus of meeting: Develop practical skills for data collection Develop practical skills for data collection Work with final forms Work with final forms Workshops/Sessions: Interactive, hands-on Workshops/Sessions: Interactive, hands-on Registry Input Form/Excel Registry Registry Input Form/Excel Registry Baseline Assessment of Core Elements Baseline Assessment of Core Elements Participant and Family Questionnaires Participant and Family Questionnaires Orientation to New Forms you haven’t seen yet Orientation to New Forms you haven’t seen yet Provider, Organizational, Community Questionnaires Provider, Organizational, Community Questionnaires Follow-up and Annual Questionnaires Follow-up and Annual Questionnaires Data Collection Guidelines update Data Collection Guidelines update Informed Consent, HIPAA, IRB Informed Consent, HIPAA, IRB Data Quality Control Data Quality Control Submission of Forms Submission of Forms

CGP Timeline December 2005 December 2005 Year 2, Meeting 1 Year 2, Meeting 1 Part 2 of Data Coordinator Training Part 2 of Data Coordinator Training Technical Assistance Workshops Technical Assistance Workshops Transmission of final excel registry file, paper and electronic forms and questionnaires to grant programs Transmission of final excel registry file, paper and electronic forms and questionnaires to grant programs IRB approval for those still in progress IRB approval for those still in progress Final planning for start date Final planning for start date January/February 2006 January/February 2006 Being recruitment/Intensive activities/implement core elements Being recruitment/Intensive activities/implement core elements Begin data collection/submission of forms Begin data collection/submission of forms March 2006 – Year 2, Meeting 2 March 2006 – Year 2, Meeting 2 HH: March 7-8, 2006 HH: March 7-8, 2006 DP: March 9-10, 2006 DP: March 9-10, 2006

Day 1 Data Coordinator Training Day 2 Data Coordinator Training Day 2 Technical Assistance Workshops Registry Assessment of Core Elements Follow-up/Annual Questionnaires Orientation to SDPI CGP Day to Day SDPI Management Discussion - Recruitment Registry Assessment of Core Elements Informed Consent, HIPAA, IRB, Data Quality, Submission of Forms Team Building Motivational Interviewing Day to Day SDPI Management Participant and Family Questionnaires Diabetes Education Strategies Team Building Clinical Questions Data Collection Q&A Provider, Organizational, Community Questionnaires Clinical Questions Excel Registry Q&A Brochure Design 101 IRB Q&A Networking Session - Hotel