COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov
Get the latest research information from NIH: https://www.nih.gov/coronavirus
NIH staff guidance on coronavirus (NIH Only): https://employees.nih.gov/pages/coronavirus/
Combat COVID Website: https://combatcovid.hhs.gov
Protocol Template for Behavioral and Social Sciences Research
The Protocol Template for Behavioral and Social Sciences Research is a resource for communicating the science, methods, and operations of a clinical trial. This template is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation. Use of the protocol template is encouraged but not required.
The Behavioral and Social Clinical Trials Template was derived from the successful NIH-FDA Phase 2/3 IND-IDE Clinical Trial Template but was adapted to include terminology and approaches used by behavioral and social scientists.
While the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation for which a stand-alone clinical protocol is required, the template can also be a useful tool for those trials funded by NIH Institutes or Centers that do not require stand-alone clinical protocols. Using the template to anticipate decision points and potential challenges before a study launches can help avoid delays down the road.