Study documentation requirements
Review types of study documentation and when they are required.
Study Documentation
Study documents demonstrate the conduct, quality, and compliance of research—and proper documentation is a crucial part of the research process. Explore specific resources and guidance related to human research study documentation.
Good Documentation Practices (GDP)
Learn best practices about GDP, and how to put these into action.
Source documents
Understand what source documents and source data are, and best practices for handling these.
Documentation of informed consent
Ensuring informed consent is documented in a legal and valid manner is critical.
Frequently asked questions
Explore FAQs about requirements, definitions, and processes.
Templates and document downloads
Review, download, and modify study documentation templates.