2. Coordinator Toolbox: What to Include Presented by: Derita Bran, RN, CCRC Manager, Clinical Trials Operations Office of Clinical Research UT Medical Group, Inc.

3. Objectives • Propose rules for a successful coordinator • Discuss the need for tools by the coordinator/study team during the conduct of a clinical trial • Present examples of logs/documents to assist the study team

4. Successful Coordinator Get and Stay Organized Keep Up-to-Date There Is Always Room for Improvement Network, Get ideas from others Rule # 1 Rule # 2 Rule # 3 Rule #4

5. Getting Organized • Start getting organized and collecting documents upon notification of potential trial • Make lists of tasks to complete • Create logs/checklists • Do not procrastinate • Set up your own systems • Keep up to date: • Filing • Notifying PI, others of study matters

6. What to Include in Your Toolbox • Resources • Feasibility Checklist • Conversion Tables • Logs/Tracking Forms • Checklists • Created Documents

7. Resources • UT Medical Group Office of Clinical Research (OCR) Website • FDA regulations and guidances • ICH GCP Guidelines • Belmont report • Nuremburg Code • Clinical Research Definitions • SOPs • IRB SOPs and Policies • Contact information for experienced CRC • FDA Warning letters • Abbreviations/Accronyms • Glossary • Research related Terms

8. Feasibility Checklist

9. Conversion Tables • Military Time • Temperature • Height • Weight

10. Military Time Conversion

11. Temperature Conversion

12. Height Conversion Table

13. Weight Conversion

14. Body Surface Area Conversion Tool • http://www.halls.md/body-surface-area/bsa.htm

15. Logs/Tracking Forms • Screening • Enrollment • Communication • Document Tracking • Meeting Record • Weekly Meeting Notes • Protocol Amendment • Temperature • Monitoring • AE/SAE • Protocol Deviation • Training Documentation • Delegation of Authority • IRB Submissions • ICF

16. Screening Log

17. Subject Enrollment

18. Communication Record

19. Document Tracking Log

20. Meeting Minutes

21. Weekly Meeting Notes

22. Protocol Amendment Tracking Form

23. Temperature Log

24. Monitoring Log

25. AE/SAE Tracking Log

26. Protocol Deviation Log

27. Training Log

28. Training Documentation

29. Training Documentation

30. Delegation of Authority

31. IRB Submissions

32. Subject ICF Signing

33. ICF Version Log

34. Documents to Create • Site Source Documents • Visit Work sheets • IC Process • Inclusion/Exclusion Criteria • Educational/Training Materials • Subjects • Study Team • Clinic/Hospital Personnel • Tip Sheets • SOPs • Summary of Protocol • Pre-printed Physician Orders • Budget Worksheet • Billing Grid • Cost Analysis Grid

35. Site Source Documents

36. Site Source Documents

37. Site Source Documents

38. Tip Sheets

39. Tip Sheets

40. SOPs • Institution • IRB • Departmental • Study Site • Sponsor/CRO

41. OCR Website • http://www.utmedicalgroup.com/ocr/OCRindex.html • Investigator/Research Personnel • Examples of Clinical Trial Tracking Form • And • Clinical Trial Tools

42. Questions