Coordinator Toolbox

Regulatory Document Management Tools:

• 1571 Form and Instructions
• 1572 Form and Frequently Asked Questions
• Good Clinical Practice: Guidance for Industry
• 3454 Form
• 3455 Form
• 3500A Form
• Adverse Event Log
• Device Accountability Log
• Documentation of Training—Sample
• Drug Accountability Log
• Investigator Protocol Acceptance Form
• IRB Communications Log
• Monitoring Log
• Procedures Log
• Protocol Deviation Log
• Quality Management Plan Chart Audit Tool
• Quality Management Plan Regulatory Binder Review Tool
• Screening Log
• Site Recruitment Materials Tracking Log
• Study Team Signature & Delegation Log
• Subject Enrollment Log
• Training Log
• Unanticipated Problems Tracking Log

Recruitment & Prescreening Tools:

• Advertising Checklist
• Advertising Proposal Template
• Data Request Form & Instructions
• Physician Referral Letter Template
• Recruitment Letter Template

Screening Tools

• Prescreening Log
• Self-Referral Subject Log
• Subject Enrollment Log
• Subject Screening Log 

Subject Management: Enrollment Thru Close-Out Tools:

• Blinding Plan
• Clinical Lab Research Requisition - order through LLU Printing Services
• Medication Log
• Pain Scales:
  • Adult Pain Scales
  • Pediatric Pain Scales
• Patient Information Sheet
• Serious Adverse Event Report Form
• Source Document-Subject Activity
• Study Gift Card Payments
• Subject Activity Log
• Subject Log
• Treatment Schedule
• Visit Scheduler Template

References:

• 21 CFR 50 Subpart B (20, 23, 24, 25, 27)
• 45 CFR 46 (sections 116 and 117)
• CITI Research Ethics Education
• Clinical Trials.Gov Registration
• FDA Forms
• FDA Guidance for Computerized Systems
• FDA Guidance on Electronic Records
• FDA PI Responsibilities
• LLEAP Access request for Study Monitors
• LLU Research Administration
• NIDDK Generic Data and Safety Monitoring Plan for Clinical Trials requiring a Data Safety and Monitoring Board
• NIDDK Generic Data and Safety Monitoring Plan for Clinical Trials not requiring a Data Safety and Monitoring Board
• NIH Glossary
• OHRP: General Informed Consent Requirements (YouTube Video)