Policy
Policy Information
- Frequently Asked QuestionsQuestions and answers about registering clinical studies and submitting results information to BMU CTR.
- FDAAA 801 and the Final RuleA summary of the U.S. federal legal requirements for clinical study registration and submission of results information.
- Clinical Trial Reporting RequirementsAn overview of key registry and global policy requirements for clinical trial registration and submission of results information.
Data Element Definitions
- Protocol Registration DEDDefinitions for protocol registration data elements for interventional and observational studies.
- Results DEDDefinitions for results data elements for interventional and observational studies.
- Expanded Access DEDDefinitions for registration data elements for expanded access studies.