top of page

Clinical Trial Protocol

Clinical trail protocol

Example #2 provided as a guide, customize as needed: Flow diagram

Clinical Study Protocol

Variability of Parkinson’s Disease Biomarker Analytes

Clinical Trials Protocol Templates

Applicants conducting phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications can use a NIH-FDA template with instructional and sample text to help write protocols. A separate template is available for applicants conducting behavioral and social sciences clinical trials. Use of these templates is optional.


To facilitate the development of clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application, the NIH and FDA collaboratively developed a Phase 2/3 Clinical Trial Protocol Template and an electronic protocol-writing tool to help investigators think through the scientific basis of their assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data.

Policy Guidelines &


The tool provides a suggested format for phase 2 and 3 clinical trials funded by NIH that are being conducted under an FDA IND or IDE Application.

A common protocol structure and organization facilitates protocol review by oversight entities.

Note that the use of the tool is voluntary and is not required for NIH applications or contract proposals.


  • NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials

  • NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans

추천 게시물
최근 게시물
태그 검색
아직 태그가 없습니다.
공식 SNS 페이지
  • Facebook Basic Square
  • Twitter Basic Square
  • Google+ Basic Square
bottom of page