Human Subjects Research Recordkeeping and Record Retention

Sponsored by the Division of Clinical Research

Investigators are required to maintain records of their human research activities. Good recordkeeping is essential for verifying the integrity of study data produced and for demonstrating investigator compliance with applicable regulations, and institutional policies and procedures. This presentation will cover: recordkeeping requirements for regulatory and subject files, maintenance and storage options, common errors identified in inspections and audits, as well as retention requirements for study files.

Presenter: Pamela Richtmyer, Director, Human Research Affairs Compliance and Education Office, MGB