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Coordinator Toolbox:

Coordinator Toolbox:. What to Include. Presented by: Derita Bran, RN, CCRC Manager, Clinical Trials Operations Office of Clinical Research UT Medical Group, Inc. Objectives. Propose rules for a successful coordinator

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Coordinator Toolbox:

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

  2. 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

  3. 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

  4. 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

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

  6. 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

  7. Feasibility Checklist

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

  9. Military Time Conversion

  10. Temperature Conversion

  11. Height Conversion Table

  12. Weight Conversion

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

  14. 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

  15. Screening Log

  16. Subject Enrollment

  17. Communication Record

  18. Document Tracking Log

  19. Meeting Minutes

  20. Weekly Meeting Notes

  21. Protocol Amendment Tracking Form

  22. Temperature Log

  23. Monitoring Log

  24. AE/SAE Tracking Log

  25. Protocol Deviation Log

  26. Training Log

  27. Training Documentation

  28. Training Documentation

  29. Delegation of Authority

  30. IRB Submissions

  31. Subject ICF Signing

  32. ICF Version Log

  33. 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

  34. Site Source Documents

  35. Site Source Documents

  36. Site Source Documents

  37. Tip Sheets

  38. Tip Sheets

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

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

  41. Questions

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