6/1/09.

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Presentation transcript:

6/1/09

What to Include Coordinator Toolbox: Presented by: Derita Bran, RN, CCRC Manager, Clinical Trials Operations Office of Clinical Research UT Medical Group, Inc. 6/1/09

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 6/1/09

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 6/1/09

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 6/1/09

What to Include in Your Toolbox Resources Feasibility Checklist Conversion Tables Logs/Tracking Forms Checklists Created Documents 6/1/09

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 6/1/09

Feasibility Checklist 6/1/09

Conversion Tables Military Time Temperature Height Weight 6/1/09

Military Time Conversion 6/1/09

Temperature Conversion 6/1/09

Height Conversion Table 6/1/09

Weight Conversion 6/1/09

Body Surface Area Conversion Tool http://www.halls.md/body-surface-area/bsa.htm 6/1/09

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 6/1/09

Screening Log 6/1/09

Subject Enrollment 6/1/09

Communication Record 6/1/09

Document Tracking Log 6/1/09

Meeting Minutes 6/1/09

Weekly Meeting Notes 6/1/09

Protocol Amendment Tracking Form 6/1/09

Temperature Log 6/1/09

Monitoring Log 6/1/09

AE/SAE Tracking Log 6/1/09

Protocol Deviation Log 6/1/09

Training Log 6/1/09

Training Documentation 6/1/09

Training Documentation 6/1/09

Delegation of Authority Other Names: Delegation of Responsibility, Study Site Signature 6/1/09

IRB Submissions 6/1/09

Subject ICF Signing 6/1/09

ICF Version Log 6/1/09

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 6/1/09

Site Source Documents 6/1/09

Site Source Documents 6/1/09

Site Source Documents 6/1/09

Tip Sheets 6/1/09

Tip Sheets 6/1/09

SOPs Institution IRB Departmental Study Site Sponsor/CRO 6/1/09

OCR Website Investigator/Research Personnel http://www.utmedicalgroup.com/ocr/OCRindex.html Investigator/Research Personnel Examples of Clinical Trial Tracking Form And Clinical Trial Tools 6/1/09

Questions 6/1/09

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