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What to Include

Presented by:Presented by:

Derita Bran, RN, CCRCDerita Bran, RN, CCRCManager, Clinical Trials OperationsManager, Clinical Trials Operations

Office of Clinical ResearchOffice of Clinical ResearchUT Medical Group, Inc.UT Medical Group, Inc.

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ObjectivesObjectives

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

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Successful Successful CoordinatorCoordinator

Get and Stay Organized

Keep Up-to-DateThere Is Always Room for

Improvement

Network, Get ideas from others

Rule # 1

Rule # 2

Rule # 3

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Rule #4

Getting OrganizedStart getting organized and collecting

documents upon notification of potential trialMake lists of tasks to completeCreate logs/checklistsDo not procrastinateSet up your own systems Keep up to date:

FilingNotifying PI, others of study matters

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What to Include in Your Toolbox

ResourcesFeasibility ChecklistConversion TablesLogs/Tracking FormsChecklistsCreated Documents

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ResourcesResources 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

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Feasibility Checklist

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Conversion Tables

Military TimeTemperatureHeightWeight

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Military Time Conversion

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Temperature Conversion

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Height Conversion Table

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Weight Conversion

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Body Surface Area Conversion Tool

http://www.halls.md/body-surface-area/bsa.htm

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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

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Screening Log

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Subject Enrollment

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Communication Record

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Document Tracking Log

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Meeting Minutes

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Weekly Meeting Notes

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Protocol Amendment Tracking Form

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Temperature Log

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Monitoring Log

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AE/SAE Tracking Log

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Protocol Deviation Log

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Training Log

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Training Documentation

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Training Documentation

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Delegation of AuthorityDelegation of Authority

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IRB Submissions

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Subject ICF Signing

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ICF Version LogICF Version Log

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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

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Site Source Documents

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Site Source Documents

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Site Source Documents

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Tip Sheets

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Tip Sheets

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SOPsInstitutionIRBDepartmentalStudy SiteSponsor/CRO

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OCR Website

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http://www.utmedicalgroup.com/ocr/OCRindex.html

Investigator/Research Personnel

Examples of Clinical Trial Tracking Form

And

Clinical Trial Tools

Questions

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