This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.
Some links will work for NIAID staff only.
Purpose
To strengthen NIAID oversight of clinical trials and studies by requiring grant recipients to provide additional information for NIAID review.
Procedure
Incorporated into the Notice of Award, NIAID clinical terms of award specify a recipient'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 and advice on the following NIAID pages:
- Research Using Human Subjects
- Clinical Trial Research
- Investigator-Initiated Clinical Trial Resources
- NIAID Clinical Terms of Award—Guidance for Compliance
Applicants and Recipients
- 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.
- Include any country-specific restrictions, such as the NIAID Clinical Terms of Award Restriction for China.
- Review recipient documentation. You will need this information before your recipients accrue patients.
- Tell principal investigators when they are permitted to begin accruing patients.
- Respond to recipients as soon as possible.
- Check with your division contact for other deadlines and instructions.
Grants Management Specialists
- Add the Clinical Terms of Award to the Notice of Award.
- Include any country-specific restrictions, such as the NIAID Clinical Terms of Award Restriction for China.
Contacts
See GMP Assignments by Geographic Region and Program Code for the appropriate grants management specialist.
Division Contacts
- Division of Allergy, Immunology, and Transplantation (DAIT)—Karina Allbritton
- Division of Microbiology and Infectious Diseases (DMID)—DMID GrantOps
- Division of AIDS (DAIDS)—Martin Gutierrez