Clinical Trials Protocol Template

The NIDCR Clinical Protocol Template provides standardized guidance to NIDCR investigators in writing and developing clinical research protocols that are in compliance with regulatory and other requirements. Use of this template also meets NIDCR’s Guidance for Complying with the NIDCR Clinical Terms of Award, Section II.

• NIDCR Interventional Protocol Template (printer-friendly Microsoft Word version available  (335KB))
  The template provides instructions (in italicized font). It also contains suggested text (in regular font) that can be included in your protocol.
• Protocol Template Working Shell (printer-friendly Microsoft Word version available  (103KB))
  The Working Shell contains headers and formatting for use in writing your protocol. Refer to the Interventional Protocol Template for instructions and suggested text. As appropriate, modify the suggested text for your specific protocol.
• Version Control Guidelines (printer-friendly Microsoft Word version available  (98KB))
  The Version Control Guidelines provide instruction for controlling the date and version of each draft and final document. Use this numbering convention for your protocol and associated documents.