Tip of the Week Archive

Observational studies are studies of human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals, but the investigator does not assign specific interventions to the study participants. These studies are often retrospective, and may include chart reviews.

Observational studies do not meet the FDA, NIH, or ICMJE definitions of clinical trials, and are not required by these organizations to be registered on ClinicalTrials.gov, but should you register anyway?

The short answer is, maybe...

There are a few reasons you might want to consider registering an observational study:

• ClinicalTrials.gov can be a great recruitment tool. People can search for your study using keywords, and may contact you if they are interested in participating.
• Some journals will require you to register the study prior to manuscript publication, even if this is done after the study is over.
• Registering your study contributes to the sharing of research information with the scientific community and the public.

If you have questions about registering observational studies, contact [email protected].