Protocol Templates & Forms

Human Research Templates

Human Research Determination Form (HRP-503): This document will be used by institutions to determine whether a proposed project constitutes research involving human subjects as defined by regulatory standards or not. Completing this form is a preliminary step in the ethical review process, ensuring that projects comply with ethical guidelines and laws protecting human subjects before any research activities begin.

Protocol Templates

We have developed protocol templates for use by researchers to describe research/human research activities.

  1. Protocol Examples for Research
Biomedical Research

If your research falls under this classification, you will need to use these templates:

  1. Biomedical Protocol Template (HRP-593): A Biomedical Protocol Template is a document used as a guideline for designing and documenting the methodology of biomedical research studies, including clinical trials, laboratory experiments, and other types of biomedical research. This template ensures that all relevant aspects of the study are thoroughly planned and documented before the study begins, facilitating clarity, consistency, and compliance with ethical and regulatory standards.
  2. Local Protocol Addendum Template (HRP-508): This is a document template used in clinical research to adapt or modify a central clinical trial protocol to reflect local practices, regulatory requirements, and ethical considerations specific to the geographical location where the trial is being conducted. These addendums are crucial for ensuring that the study is executed in compliance with local laws and standards, while still maintaining the integrity and objectives of the central protocol.
  3. Data and Specimen Analysis Protocol (HRP-1704): This document outlines the standardized methods and procedures for analyzing data and biological specimens collected during a clinical trial or research study. This protocol is crucial for ensuring the reliability, reproducibility, and integrity of the data analysis process. It serves as a guide for researchers and laboratory personnel on how to handle, process, analyze, and store specimens, as well as how to manage and analyze the data derived from these specimens.
Social Behavioral Research

If your research falls under Social Behavioral research, use these protocol templates:

  1. Social Behavioral Protocol Template: This Template is designed to help researchers outline and communicate the details of their studies in social, behavioral, or educational research. This template is intended primarily for use by those conducting research in these areas, and it facilitates the description of research activities, methodologies, and operations of a study. It's part of a set of tools and resources provided by research institutions and governing bodies to ensure that studies are well-planned, ethical, and in compliance with regulatory standards.
  2. Social Behavioral Protocol Template Appendix