1. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Special Diabetes Program for Indians Competitive Grant Program SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Orientation for New Staff Day 2 Data Submission Process

2. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program DATA SUBMISSION PROCESS  Program file organization  Data Submission Reference Card  Electronic submission/package submission  Tracking Logsheet  Avoiding PHI  Error Notification Letters  The Forum

3. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Program File Organization

4. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program SDPI Competitive Grant Program Program File Organization File folders for participant files –Classification file folder (3 dividers) File cabinet –Eligible: Consented, Waiting to consent –Not Eligible or refused –Project Forms: separate Participant file –Labeling file tabs –Participant Record Form (R2 – not submitted to CC) SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program

5. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Data Submission Reference Card

6. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program DP Data Submission Reference Card

7. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program DP Data Submission Reference Card Step 1 –Check completeness of each form you are submitting. Make sure to have NDPID #, Site #, and Participant ID # on each form. For scannable forms, check that all bubble are correctly filled in and keep forms intact. Double-check there is no PHI (Protected Health Information) on any of the forms. Make a copy of each form to be submitted for your records. Step 2 –Fill out the Tracking Log Sheet. Name your file like the following: 55101.1 – CC – DP Tracking Logsheet phase 2 – 04.27.2006. Only include IDs/information of those participants for whom you are submitting forms. Print one copy of the Tracking Log Sheet for your own record. If you have forms to submit, print another copy of it to include in the package. Step 3 –Prepare the Excel Registry (Detailed instructions can be found on the website). Back up your working copy of the Excel Registry. Name your file like the following: 55101.1 – CC – DP Excel Registry ver 3 – 04.27.2006. Remove Protected Health Information (PHI) from your Excel Registry copy using the Macro. Step 4 –Prepare the submission email. Name your e-mail subject line like the following: 55101.1 registry_log 04.27.2006. Attach both the Tracking Log Sheet and the de-identified Excel Registry files to your e-mail. Ask another staff member of your program to open the attached Excel Registry and double-check that it is de-identified. If it is de-identified, ask her/him to type a sentence in the submission email certifying that s/he has double-checked the Excel Registry. Send the submission email with the certification to the CC on your scheduled dates. Step 5 –Prepare the package. Only send a package in the mail if you have new completed participant forms to submit! Double-check that the forms to be submitted match those listed on the printed Tracking Log Sheet. Double-check that there is no PHI on the forms being submitted. Print a copy of the Tracking Logsheet that you e-mailed to the Coordinating Center and include it in the package. Mail the package to the Data Coordinator at the Coordinating Center. Sample mailing labels are available on the website: http://www.uchsc.edu/ai/sdpi/dp/data/dp_data.htm. (Formatted for Avery labels 5163)http://www.uchsc.edu/ai/sdpi/dp/data/dp_data.htm Note: On your scheduled submission dates you are required to submit the Tracking Logsheet and de identified Excel Registry via e-mail to the Coordinating Center, even when you have no completed forms or questionnaires to submit.

8. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program HH Data Submission Reference Card Step 1: –Check completeness of each form you are submitting. Make sure to have NDPID #, Site #, and Participant ID # on each form. For scannable forms, check that all the bubbles are correctly filled in and keep forms intact. Double-check there is no PHI (Protected Health Information) on any of the forms. Make a copy of each form to be submitted for your records. Step 2: –Fill out the Tracking Log Sheet. Name your file like the following: 55201.1 – CC – HH Tracking Logsheet phase 1 – 04.27.2006. Only include IDs/information of those participants for whom you are submitting forms. Print one copy of the Tracking Logsheet for your own record. If you have forms to submit, print another copy of it to include in the package. Step 3: –Prepare the Excel Registry (Detailed instructions can be found on the website). Back up your working copy of the Excel Registry. Name your file like the following: 55201.1 – CC – HH Excel Registry ver 3 – 04.27.2006. Remove Protected Health Information (PHI) from your Excel Registry copy using the Macro. Step 4: –Prepare the submission email. Name your e-mail subject line like the following: 55201.1 registry_log 04.27.2006. Attach both the Tracking Log Sheet and the de-identified Excel Registry files to your e-mail. Ask another staff member of your program to open the attached Excel Registry and double-check that it is de-identified. If it is de-identified, ask her/him to type a sentence in the submission email certifying that s/he has double-checked the Excel Registry. Send the submission email with the certification to the Coordinating Center on your scheduled dates (see your submission calendar). Step 5: –Prepare the package. Only send a package in the mail if you have new completed participant forms to submit! Double-check that the forms to be submitted match those listed on the printed Tracking Log Sheet. Double-check that there is no PHI on the forms being submitted. Mail the package to the Data Coordinator at the Coordinating Center. Sample mailing labels are available on the website: http://www.uchsc.edu/ai/sdpi/hh/data/hh_data.htm. (Formatted for Avery labels 5163)http://www.uchsc.edu/ai/sdpi/hh/data/hh_data.htm Note: On your scheduled submission dates you are required to submit the Tracking Log Sheet and de-identified Excel Registry via e-mail to the Coordinating Center, even when you have no completed forms or questionnaires to submit.

9. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Excel Registry Tracking Logsheet

10. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Excel Registry (DP)

11. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Excel Registry (HH)

12. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program DP Tracking Log Sheet Phase 2 Data Submission Reference Card: Step 2

13. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program DP Tracking Log Sheet Phase 2 Data Submission Reference Card: Step 2

14. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program HH Tracking Log Sheet Phase 1 Data Submission Reference Card: Step 2

15. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program HH Tracking Log Sheet Phase 1 Data Submission Reference Card: Step 2

16. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Excel Registry and Tracking Log Sheet E-mail convention Data Submission Reference Card: Step 4 Always 2 attachments: Tracking Log Sheet and Excel Registry

17. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Excel Registry and Tracking Log Sheet E-mail convention Data Submission Reference Card: Step 4 Always 2 attachments: Tracking Log Sheet and Excel Registry

18. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Avoid sending Protected Health Information (PHI) to the Coordinating Center

19. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Protected Health Information (PHI) List of identifiers that must be removed before forwarding documents to the Coordinating Center Data sent to the Coordinating Center cannot include any of the following 18 fields of information: names, geographic subdivisions smaller than a state (tribe is ok), date of birth and date of death, telephone numbers, fax numbers, electronic mail addresses, social security numbers, medical record numbers, health plan beneficiary numbers, account numbers, certificate/license numbers, vehicle identifiers and serial numbers (including license plate numbers), device identifiers and serial numbers, URLs, IP address numbers, biometric identifiers (including finger and voice prints), full face photographic images and any comparable images and any other unique identifying number, characteristic or code. * for all subjects over 89 years of age, all elements of dates including year indicative of their age cannot be used, however, age can be aggregated into a category of age 90 or older. None of these identifiers should be forwarded to the Coordinating Center. These should be removed from all data collection documents and e-mail correspondence. They should also be removed from all other forms submitted to the coordinating center such as Serious Adverse Event Forms (date of death is ok on this form); and Incident Report Forms.

20. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Error Notification Letters (ENL)

21. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Error Notification Letters (ENL) Sent out monthly via e-mail to Data Coordinator and Program Coordinator. Sent from CGP e-mail: SDPI.CGP.CC@UCHSC.edu (do not respond directly to Jeanne or Karen)SDPI.CGP.CC@UCHSC.edu Corrections should be made directly on the letter and reply directly to CGP e-mail with the letter attached.

22. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program ENL (continued) Instructions are on the website: “How to Respond to ENL”. If there are additional questions on participant forms, you may see it subsequent times on ENL. Please read the ENL carefully before you send it back to make sure all corrections have been made.

23. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program ENL Common issues Baseline: –If request is for baseline, then data must be from baseline. For example, meds at baseline (name, dose, frequency) and hip & waist at baseline. Ditto for follow-up & annual. Minutes of physical activity ECG & cardiac clearance required.

24. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program The Forum

25. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program The Forum Purpose: ► Discussion board for program sites. To share ideas and information among grantees. Questions – data or program: ► If you have questions, ask the Coordinating Center staff directly. Do not go through the forum for program or data questions. Please contact directly:DP – Alisa or Karen HH – Sandra or Jeanne Registration: ► Registration to use the Forum is easy.

26. SDPI Competitive Grant Program SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Karen Wilde Rogers DP Data Coordinator CGP Coordinating Center karen.rogers@uchsc.edu karen.rogers@uchsc.edu 303.724.1422 Jeanne M. Amos HH Data Coordinator CGP Coordinating Center jeanne.amos@uchsc.edu jeanne.amos@uchsc.edu 303.724.0423