Clinical Trials Protocol Template for the Behavioral and Social Sciences

The Clinical Trials Protocol Template for the Behavioral and Social Sciences 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 subsequent delays and problems.

DECISION SUPPORT TOOL: Features to Consider in Determining if a Clinical Trial is Phase II or Phase III

This document is the result of a working group led by the Office of Behavioral and Social Sciences Research, with participants from other Institutes, Centers, and Offices. It is a designed to be a resource to help investigators, program officers, and reviewers determine if a behavioral or social science study is better characterized as a Phase II or a Phase III clinical trial. Distinguishing earlier phases of clinical trials (Phase 0 or I) is not usually difficult but distinguishing between a Phase II and III study can be more challenging, particularly for non-drug trials. Being thoughtful about this distinction is important for a variety of reasons, not least of which is that a Phase III designation for an NIH funded clinical trial generally requires following additional policies and practices beyond those that already apply to Phase II clinical trials, such as the requirement for valid analysis and for a Data and Safety Monitoring Board (DSMB).

Good Clinical Practice for Social and Behavioral Research eLearning Course

In 2016, NIH issued a policy establishing an expectation that all NIH-funded investigators and staff involved in conducting, overseeing, or managing clinical trials should be trained in Good Clinical Practice (GCP) and should refresh their training at least every three years. The principles of GCP ensure the safety, integrity, and quality of clinical trials. GCP provides a standard for compliance, implementation, data collection, monitoring, and reporting, and outlines the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors, and monitors. In 2024, course material was updated to provide additional training on regulatory changes and reporting requirements, enhanced accessibility features, and a new module on community and stakeholder engagement.

Accessing the Training Modules

The course materials are free to access and use. There are several ways to access the training:

Phase III Trials

NIH’s definition of a Phase III clinical trial is quite broad, including drug studies, device studies, behavioral interventions, epidemiological studies, community trials, and more. Phase III trials are usually large, prospective trials that compare two or more interventions against other standard or experimental interventions. In this next episode of our NIH All About Grants podcast (MP3 / Transcript) we explain what a Phase III trial is, how it compares to other types of clinical trials, considerations for your application and its review, how these studies influence standards of care, helpful tools and other resources, and much more. The guests include Ms. Dawn Corbett, NIH’s Inclusion Policy Officer, and Dr. Christine Hunter, former OBSSR Acting Director.