What Study Information Should Be Included on a ClinicalTrials.gov Entry?

A ClinicalTrials.gov study record is intended to summarize key information from a study’s protocol and the study’s findings. The study sponsor or investigator is responsible for ensuring that their studies follow all applicable laws and regulations and for submitting complete, accurate, and up-to-date information about their study. 

Key information when registering a study:

• Eligibility criteria describing who can participate
• A description of the interventions under study
• Study design information (such as the study type and how participants are assigned to interventions)
• Primary and secondary outcome measures
• Current status and key dates
• Contact information and study site locations

When a study is completed, results information is submitted and added to the same study record, including:

• Participant flow
• Baseline characteristics
• Outcome data
• Adverse events

The summary information is similar to content expected in publications, without the narrative summaries or interpretation of findings. 

Disclosing study information in a timely manner:

• Provides accountability to the prespecified research design and outcomes when researchers report trial results
• Allows identification and analysis of all relevant trials within a research domain
• Supports participant enrollment  
• Fulfills obligations to research participants that their contributions will advance science
• Aids in countering publication bias and selective reporting
• Facilitates systematic reviews and meta-analyses that utilize the evidence base and advance public health
• Prevents unnecessary duplication of research
• Promotes research collaboration

Additional Resources:

• Protocol Registration Data Element Definitions
• Results Data Element Definitions
• Frequently Asked Questions
• FDAAA 801 and the Final Rule
• Requirements for Registering & Reporting NIH-Funded Clinical Trials