Table of Contents

GUIDING PRINCIPLES

NUREMBERG CODE
DECLARATION OF HELSINKI
THE BELMONT REPORT

FEDERAL REGULATIONS

21 CFR 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
21 CFR 50 PROTECTION OF HUMAN SUBJECTS
21 CFR 54 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
21 CFR 56 INSTITUTIONAL REVIEW BOARDS
21 CFR 312 INVESTIGATIONAL NEW DRUG APPLICATION
21 CFR 600 SUBCHAPTER F - BIOLOGICS
21 CFR 800 SUBCHAPTER H - MEDICAL DEVICES
21 CFR 812 INVESTIGATIONAL DEVICE EXEMPTIONS
45 CFR 46 FEDERAL POLICY FOR THE PROTECTION OF HUMAN SUBJECTS

INTERNATIONAL CONFERENCE ON HARMONISATION

OFFICIAL WEBSITE FOR ICH
European Commission - Enterprise and Industry DG
EU DIRECTIVES
E6 GOOD CLINICAL PRACTICE CONSOLIDATED GUIDELINE

FDA GUIDANCE

INFORMATION SHEETS FOR IRBS AND INVESTIGATORS (1998)
GUIDELINE FOR THE MONITORING OF CLINICAL INVESTIGATIONS
COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS (1999)
ACCEPTANCE OF FOREIGN CLINICAL STUDIES (2001)
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS (2001)
Significant Differences in FDA and HHS Regulations
Self-Evaluation Checklist for IRBs

FDA COMPLIANCE PROGRAMS

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL FOR SPONSORS, CROs AND MONITORS (PROGRAM 7348.810)
FDA COMPLIANCE PROGRAM GUIDANCE MANUAL FOR CLINICAL INVESTIGATORS (PROGRAM 7348.811)

MISC INFORMATION AND CONTACTS

FDA District Offices
Important FDA Contacts for Clinical Trials
Web Sites of Interest