A 21 CFR Part 11 compliant graphically based electronic system for clinical research documentation.

Area of Science:

• Clinical research informatics
• Electronic data capture systems

Background:

• Clinical research protocols generate extensive documentation requirements.
• Current electronic data transfer methods necessitate custom databases for each study.
• Paper-based records are becoming increasingly voluminous.

Purpose of the Study:

• To develop a generalized electronic database system for clinical research documentation.
• To create a system that mimics the advantages of paper recordkeeping.
• To meet regulatory requirements for electronic systems in clinical research.

Main Methods:

• Developed a graphically based electronic source documentation technology.
• Utilized tablet computers as surrogates for paper records.
• Implemented a system with non-proprietary components feeding central data archives.

Main Results:

• The system successfully mimics paper recordkeeping advantages.
• The technology meets U.S. Food and Drug Administration requirements for electronic systems.
• The system has been utilized in over 20 pharmaceutical research studies for more than two years.

Conclusions:

• A novel electronic system effectively manages clinical research documentation.
• The technology provides a generalized, compliant solution for source documentation.
• This approach enhances data integrity and auditability in clinical trials.