Policies and Guidelines for Investigator-Initiated Clinical Trials

Reviewed February 3, 2017

The NIAMS is committed to improving the health of patients with rheumatic, musculoskeletal, and skin diseases by supporting investigator-initiated clinical trials that lead to better clinical outcomes. The NIAMS' goal is to identify and fund trials that are as timely and informative as possible, and that will lead to improvements in clinical practices for disease prevention, diagnosis, and treatment. To this end, NIAMS has enhanced its clinical trials program.

How to Apply for Funding for Planning and Implementing a Clinical Trial

NIAMS Investigator-Initiated Clinical Trials Policies

Update to NIAMS Policy Regarding Submission of Clinical Trials Applications (NOT-AR-16-015).

PLEASE NOTE: NOT-AR-16-015 applies to clinical trial applications submitted to the "NIH Research Project Grant" (Parent R01 (PA-16-160)) and the "NIH Exploratory/Developmental Research Grant" (Parent R21 (PA-16-161)) Program Announcements where the primary objective is mechanistic, rather than a clinical outcome. This policy will also apply to any subsequent reissuances of these Funding Opportunity Announcements (FOAs).

NIAMS Clinical Funding Opportunity Announcements

Frequently Asked Questions

NIAMS Policy: Conversion of a Grant to a Cooperative Agreement

Supporting Information

Clinical Trial Planning and Implementation Milestones

Clinical Trial Planning Milestone Checklist

Consultation with NIAMS staff

Letters of Request for Applications with Budgets $500,000 or More in Direct Costs

Tools to Use Once You Find Out You Will Be Funded

NIAMS Policies, Guidelines and Sample Templates for Clinical Trials

Clinical Trials Registration

NIH and Federal Policies

For More Information

Contact a NIAMS Clinical Research Manager

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