Clinical Terms of Award SOP

This standard operating procedure (SOP) includes the following sections: PurposeProcedureContacts, and Links.

Some links will work for NIAID staff only.

Purpose

To strengthen NIAID oversight of clinical trials and studies by requiring grantees to provide additional information for NIAID review.

Procedure

Incorporated into the Notice of Award, NIAID clinical terms of award specify a grantee's responsibilities and deadlines for providing documentation before and during a study.

There may be additional terms for certain countries; for example, see the NIAID Clinical Terms of Award Restriction for China.

Grant applications must follow human subjects instructions in the SF 424 Application Guide.

Find more information on human subjects research at NIAID Human Subjects Resources.

Applicants and Grantees

  • Read the NIAID Clinical Terms of Award for details on what to do.
  • When you receive your Notice of Award, contact your program officer to discuss data sharing and monitoring.
  • Provide information to your program officer as specified in your Notice of Award.
  • Before you begin patient accrual, send NIAID some or all of the information listed in the terms document. Your specific requirements will vary based on the nature of your research.
  • Make sure you are gathering the data you will need for reporting during the award.
  • Determine whether your study is an applicable clinical trial, and if so register and maintain an updated record at ClinicalTrials.gov.

Program Officers

  • Indicate on the Program Officer Checklist whether the clinical terms of award should be part of the Notice of Award.
  • Review grantee documentation. You will need this information before your grantees accrue patients.
  • Tell PIs when they are permitted to begin accruing patients.
  • Respond to grantees as soon as possible.
  • Contact your division coordinator for other deadlines and instructions.

Grants Management Specialists

Contacts

See GMP Assignments by Geographic Region and Program Code for the appropriate grants management specialist. ​

Division Coordinators

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Content last reviewed on January 8, 2018