National Institute of Allergy and Infectious Diseases
NIAID Home Health & Science Research Funding Research News & Events Labs at NIAID About NIAID

Clinical Research Toolkit
 Clinical Research Standards
 Clinical Trials Protocol Templates
 Guidance, Policies & SOPs
 Related links


Trans NIAID Clinical Research Toolkit

Clinical Trials Protocol Templates

The creation of the NIAID Clinical Trial protocol templates was approved by the Executive Committee in 2006. The goal of the templates is to provide a standardized template to assist NIAID investigators in writing and developing clinical research protocols that are in compliance with regulatory and other requirements. The use of these templates is not mandatory but highly recommended.

Protocol Template Guidance (PDF)
To provide a standardized template to assist NIAID investigators in writing and developing clinical research protocols that are in compliance with regulatory and other requirements.

Intramural Protocol Templates

For comments or assistance with the intramural template sets, please contact Heather Bridge at bridgeh@niaid.nih.gov.

The NIAID Protocol Template Working Group (PTWG) values your feedback on your experience using the Intramural Protocol Template(s) and Guidance documents. Please take a moment to download, complete and e-mail the survey to Heather Bridge at bridgeh@mail.nih.gov, thank you.

Intramural Protocol Templates and Guidance Document Survey 2008 (Word)

Intramural Clinical Trial Protocol Template

Intramural Natural History Protocol Template

Extramural Clinical Trials Protocol Template
For comments or assistance with the extramural template set, please contact Mary Smolskis at msmolskis@niaid.nih.gov.

back to top


Contact Info

To request prior document versions, email ncrsexecsec@niaid.nih.gov

See Also

  • Clinical Studies
  • Division of Clinical Research



  • Contact Info

    To request prior document versions, email ncrsexecsec@niaid.nih.gov

    See Also

  • Clinical Studies
  • Division of Clinical Research