writing research protocol template

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Protocol templates for clinical trials.

NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research:

• Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications
• Behavioral and social sciences research involving humans

These clinical protocol templates can be accessed via the secure web-based e-Protocol Writing Tool and as Word templates  

Clinical E-Protocol Writing Tool  

Benefits of the e-Protocol Writing Tool include:

• enables participation for multiple writers and reviewers
• allows assignments for writers and collaborators
• tracks progress and ensure document version control

The use of these templates is recommended, but not required.

Word Templates

Related notices.

• NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
• NOT-OD-19-092 NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans
• Key Dates & Policy Notices
• Case Studies
• Training & Resources
• Important Terms
• Human Subjects Research
• ClinicalTrials.gov
• Resource on Research Methods  
• ClinRegs: international clinical trials regulations
• For NIH Staff

• Resources & Guidance

Protocol Templates & Forms

Is your study human research.

• Human Research Determination Form (HRP-503) :  (Rev. 07-01-2023) Researchers can self-determine whether their activities are human research. If you are unable to determine whether your activities meet the regulatory definition of “research” with “human subjects,” OR if you would like/need the IRB to evaluate your study to provide an official determination that your activity is not human subjects research, complete this form.
• Guidance on the Use of Public Use Data : Researchers using specified “public use” data sets for secondary analysis may not need to submit to the IRB for review since publicly available data does not constitute research with human subjects (as defined under 45CFR46:102). See our Policies & Guidance  webpage for more information.

If Northwestern University is the Primary Awardee of a federal grant where a subaward  institution or organization  will conduct non-exempt human subjects research then the human research determination form is   NOT  appropriate because 5 CFR 46.103(f)  applies . A full IRB application should be submitted with full details outlining which portions of the work will be conducted at Northwestern and/or by other institutions and organizations. Please see our  Guidance Regarding Federal Requirements for IRB Review of Grants and Single IRB Planning webpages for more information. 

Which protocol template should you use?

The IRB Office has developed protocol templates for use by the Northwestern University research community to describe research/human research activities. 

• Consult our  Protocol Conversion Guide 11-9-2014 for important information about using templates with new submissions or converting templates for previously approved research. 
• When developing the recruitment sections of your protocols please refer to our  Recruitment Materials and Guidelines  webpage.

Biomedical Research Templates

• Biomedical Protocol Template (HRP-593) : (Rev. 11-10-2023) This document is intended for use primarily by those conducting biomedical research.
• Local Protocol Addendum Template (HRP-508) : (Rev. 11-01-2023) This document is intended for use when local information is not represented in the main protocol document received from a study sponsor or non-Northwestern University research collaborator. The Local Protocol Addendum should be uploaded along with the main protocol document in eIRB+ and modified as necessary throughout the duration of the study to account for local changes to the research. 
• Data and Specimen Analysis Protocol (HRP-1704 ) : (Rev. 05-01-2023) This document is intended for use primarily by those involved in analysis of data and/or specimens.

Social and Behavioral Research Templates

• Social Behavioral Protocol Template (HRP-583) :   (Rev. 11-06-2024) This document is intended for use primarily by those conducting social, behavioral, or educational research. If your research involves physical procedures or devices, you may need to include sections that are contained in the biomedical template protocol.
• Social Behavioral Protocol Template Appendix B (HRP-1724)  (Rev. 05-01-2023) 
• Local Protocol Addendum Template (HRP-508) : (Rev. 11-17-2022) This document is intended for use when local information is not represented in the main protocol document received from a study sponsor or non-Northwestern University research collaborator. The Local Protocol Addendum should be uploaded along with the main protocol document in eIRB+ and modified as necessary throughout the duration of the study to account for local changes to the research. 
• Data and Specimen Analysis Protocol (HRP-1704 ) :  (Rev. 05-01-2023) This document is intended for use primarily by those involved in analysis of data and/or specimens.

Supporting Documents

• Registry (Subject Pool) Best Practices (HRP-1103) : A registry or subject pool is a list or database of participants that multiple investigators will use for recruitment in the future. A registry requires IRB approval as an independent project.
• FORM Emergency Use of Investigational Drug, Device, or Biologic (HRP-1203)
• FORM Compassionate Use Request for Investigational Devices (HRP-1201)
• FORM Radiation Dosimetry (HRP-1202)
• Debriefing Information Template (HRP-1726)
• Incident Assessment Tool (HRP-1207) : This form can be used to assist the Principal Investigator in determining if an incident that occurs meets the IRB reporting criteria.