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For question regarding specific policies and standards, contact the DAIT Policy Group

Additional Information From NIAID

Division of Allergy, Immunology, and Transplantation (DAIT) Clinical Research Policies and Standards

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About DAIT Clinical Research Policies and Standards Documents

Policies and standards are essential to any clinical research enterprise. In this regard, all clinical research funded and/or sponsored by NIAID must be compliant with these policies and standards in addition to the NIAID Clinical Terms of Award.

DAIT Clinical Research Policies and Standards documents serve as resources for DAIT collaborators and staff, in addition to National Institutes of Health clinical research policies and 45 CFR 46, subparts B–D. Section 2 of each document, Scope, outlines the applicability of each policy and standard to different types of human subjects research (i.e., clinical research, observational research, or clinical trials).

DAIT expects compliance with all applicable policies within 30 days of the “effective date” stated on each document. DAIT may, at its discretion, request site monitors to spot-check documentation for compliance to these policies and procedures during monitoring visits.

DAIT is now soliciting comments from grantees and others involved in DAIT Clinical Research on the following new DRAFT policies:

Please submit any comments to: NIAIDCROPPolicyGroup@niaid.nih.gov. Include the name of the document and line number(s) that correspond to your comments.

Comment period:

The comment period was open from Aug. 1 - Sept. 16, 2012. It is now closed.

Last Updated August 20, 2012

Last Reviewed August 20, 2012