20110106 FDA draft guidance "Electronic Source Documentation in Clinical Investigations"

Electronic Source Documentation in Clinical Investigations
DRAFT GUIDANCE

TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
III. ELECTRONIC SOURCE DOCUMENTS AND SOURCE DATA
A. Tier 1 - Data Entry
1. Data Elements
2. Data Element Attributes and Data Element Identifiers
3. Modifications and Corrections
4. Repeated Appearance of the Same Data Element in an eCRF
5. Electronic Prompts to Ensure Accuracy and Completeness of Data
6. Originators of Data Elements
7. Identification of Data Originators
B. Tier 2 – Data Review
1. The Investigator
2. The Investigator’s Copy of the eCRF
C. Tier 3 -- Data Processing and Transmission
IV. REGULATORY REVIEW COLLABORATION
GLOSSARY OF TERMS