Investigator Site Resource/Tools

FDA Audit Prep Worksheet/Checklist
Monitoring Visits Prep Checklist
Financial/Budget Projections Template
Study Coordinator Task List
Telephone Communication Record
SOP Template

Sponsor Resource/Tools

FDA Compliance Program and Guidance Manual – BioResearch Monitoring
FDA Small Business Guide
Free Statistical Analysis Software
CDRH FDA Forms
CDER FDA Forms
CBER FDA Forms

Other Tools

Medline Plus: Medical Encyclopedia
Merck Online Medical Library
WebMD- Drug Listing
Medical Calculators