NIAID Clinical Research Standards

NIAID Clinical Research Standards (PDF)

What is the purpose of the NIAID Clinical Research Standards?

The NIAID Clinical Research Standards serve as the framework for Institute and Division assessment and improvement of clinical research processes. While many of the policy requirements defined in this document are well established, implementing the Standards will help NIAID Divisions to develop comprehensive clinical research policies and procedures, and provide opportunities for Divisions to share best practices.

Why were these Standards developed?

The Standards were developed to define requirements that maximize the quality of NIAID clinical research. They also provide flexibility to account for the many contexts in which research is reviewed and conducted at NIAID. It is anticipated that these Standards will serve as a tool to continuously enhance the quality of clinical research. As such, they will be reviewed and revised on an as-needed basis and at least on a yearly basis after implementation.

How were these Standards developed?

In the fall of 2006, a trans-Division working group convened to draft the Standards document. The document was then submitted to the NCRS (NIAID Clinical Research Subcommittee of the NIAID Executive Committee [EXCOM]) for review and was subsequently reviewed and approved by the NIAID EXCOM.

When did the Standards go into effect?

The Standards went into effect when they were approved by NIAID EXCOM on January 25, 2007.

How will compliance with these Standards be assessed?

NIAID Divisions complete a self-assessment of compliance with the Standards to identify areas for additional policy development and harmonization. Plans to assess compliance on an ongoing basis are under development by the NCRS.

Where can I get more information?

You are encouraged to bring any questions to your NCRS representative (PDF).

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