Before You Enroll Participants

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Documentation. Before issuing your Notice of Award, NIAID may require that you submit additional documents just-in-time. For details, see You Will Send Some Materials Just-in-Time.

If you have a bar from peer reviewers, work with your program officer to resolve it and submit a revised plan. See the Bars to Grant Awards SOP for details.

NIAID's grants management specialists will also check to see whether your organization has the following in place:

• A human subjects assurance on file with the Office for Human Research Protections.
• Certification to NIAID that an institutional review board or independent ethics committee, designated under your organization's Federalwide Assurance, reviewed and approved all nonexempt human subjects research proposed in your application.

You can begin to enroll participants once program and grants staff have received, reviewed, and approved all amended or missing documentation.

Registration. By law, you must register applicable clinical trials on ClinicalTrials.gov. However, NIH urges you to register all clinical trials on ClinicalTrials.gov even when registration is not required. See Section 801 of Public Law 110-85 and the November 16, 2007, Guide notice.

To determine when you must register, read When Must I Register My Trial in the December 11, 2008, Guide notice.

Submit the information to ClinicalTrials.gov. For registration information, see ClinicalTrials.gov Protocol Registration System.

Contact your program officer for assistance and to learn more about the registration process.

For additional information, see  Clinical Trials.gov’s Protocol Registration System PRS and U.S. Public Law 110-85 and NIH's Fact Sheet -- Registration at ClinicalTrials.gov: As required by Public Law 110-85, Title VIII.

Also see Section 113 of Public Law 105-115 and Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions.

Make sure you understand the International Committee of Medical Journal Editors' (ICMJE) registration policy if you want your study published by a journal using ICMJE's standards.

Depending on the type of trial, ICMJE's publication policy may require that you register before you enroll your first patient. To see how this applies to your study, read "Is This Clinical Trial Fully Registered?".

Additional Resources

• Plan for Registering an IRB or IEC and Obtaining an FWA
• Before Enrolling Participants checklist

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