GpCRC Gastroparesis Clinical Research Consortium Pilot Study of the Safety, Feasibility and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG) Standard Operating Procedures Part I: Clinical Center Operations 31 March 2011 i GLUMIT-DG SOP Part I: Clinical Center Operations Contents 1. Design overview. 1 1.1. Design synopsis.. 2 1.2. Data collection schedule. 6 1.3. Whole blood draw schedule. 7 2. Eligibility and enrollment. 8 2.1. Inclusion and exclusion criteria. 9 2.2. Run-in period. 10 2.3. Calculation of Gastroparesis Cardinal Symptom Index (GCSI) . 11 2.4. Guidelines for repeat determinations of eligibility.. 12 2.5. Co-enrollment in Gastroparesis Registry. 13 2.6. Enrollment and eligibility checking. 14 3. Certification. 15 3.1. Certification overview of GLUMIT-DG.. 16 3.2. Clinical center certification.. 17 3.3. Personnel certification . 18 4. Human subjects.. 19 4.1. Background. 20 4.2. Institutional Review Board process. 21 4.3. Consent administration. 22 4.4. Time considerations for obtaining consent.. 23 4.5. Consent handling.. 24 4.6. Informing participants of changes to consent statement after enrollment. 25 4.7. HIPAA considerations. 26 5. Study visits. 27 5.1. Overview of visit schedule. 28 5.2. Visits, data forms, and procedures. 32 5.3. Guide for screening visits. 34 5.4. Guide for run-in visits with insulin pump training. 36 5.5. Visit window: enrollment and follow-up. 37 5.6. Interim (unscheduled) visits or telephone contacts.. 38 6. Study procedures.. 39 6.1. Assignment of study identifiers. 40 6.2. Screening Contact Log (SL Form). 41 GPCRC/GLUMIT-DG/GLUMIT-DG_10SOPI\Manall_7 GLUMIT-DG SOP – Part I March 31, 2011 (2:05pm)hll Confidential, not for citation ToC.Pg ii GLUMIT-DG SOP Part I: Clinical Center Operations 6.3. Upper Endoscopy Documentation (EG form).. 42 6.4. Gastric Emptying Scintigraphy Documentation (GE form). 43 6.5. Electrogastrogram water load and caloric satiety testing (WL and ST form). 45 6.6. Baseline Medical History (BH form). 58 6.7. Follow-up Medical History (FH form). 59 6.8. Physical Examination (PE form).. 60 6.9. Height and weight measurements. 62 6.10. Waist and hip circumference measurement. 63 6.11. Neuropathy foot exam.. 65 6.12. Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) (GD form).. 68 6.13. Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) (UG form). 69 6.14. Laboratory Results (LR form).. 70 6.15. Plasma Collection for Biosample Repository (BP form). 71 6.16. Training Documentation (TD Form).. 77 6.17. Adverse Event Reporting (IE form). 78 6.18. Procedures for downloading medtronic CGMS iPro data. 82 6.19. Procedures for Carelink downloading of data. 90 6.20. Procedures for Re-screen in GLUMIT-DG (RC form).. 99 6.21. Procedures for Missed or Incomplete Visits (MV form). 100 6.22. Procedures for patients lost to follow-up. 101 6.23. Procedures for mortality closeout (DR form). 102 6.24. Medical management of patients. 103 6.25. Study Closeout (CO form). 107 7. Forms management.. 108 7.1. Clinical center ID codes. 109 7.2. Patient identifiers. 110 7.3. Visit ID code. 111 7.4. General guidelines for forms completion. 112 7.5. Instruction box. 113 7.6. Form skips, stops, caution ineligibility symbols.. 114 7.7. Headers and footers.. 115 7.8. Key fields. 116 7.9. Missing data. 117 7.10. Administrative sign off. 118 7.11. Handling forms. 119 7.12. Data rounding rules.. 120 7.13. Data audits and edits. 121 8. Quality assurance. 122 8.1. Site visits.. 123 8.2. Performance monitoring. 126 8.3. Data quality surveillance.. ..