The Carbone Cancer Center (CCC), Health Sciences Institutional Review Boards (IRB) Office, and Institute for Clinical and Translational Research (ICTR) initiated efforts to develop a series of templates that investigators can adapt to ensure all critical elements of a protocol are present. Templates will be developed for the most common investigator-initiated study designs with the goal of generating high-quality protocol and expediting regulatory approval. These optional templates are (will be) designed to be disease-agnostic, adhere to NIH and international research standards, and incorporate “boilerplate” language specific to UW-Madison’s research infrastructure.
Templates Based on Study Design
- Carefully review the Protocol Template Instructions (7-22-19) before getting started.
- No template is likely perfect for a given study without some modification. Investigators should adapt templates, adding and removing sections or indicating “not applicable.”
- Templates are periodically updated to account for regulatory changes, ARROW modifications, and user feedback. Check back frequently to ensure use of the most up-to-date template.
- Not sure which template to use, need additional help, or want to share feedback, contact a protocol development specialist?
Clinical Trials Templates
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ICTR Drug/Device/Behavioral Intervention Template
- Intended for prospective, non-oncologic clinical trials evaluating drugs, devices, biologics, behavioral, or clinical interventions.
- Suitable for studies conducted under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) and for all other clinical trials.
- Click here to receive a copy of the template by email.
ICTR Observational Template
- Intended for non-oncologic observational studies including those where the focus is on evaluating health characteristics, risk factors, natural history, and variations in disease progression.
- Suitable for projects where the investigator does not alter the care that subjects receive, but records observations and analyzes data.
- Click here to receive a copy of the template by email.
UW Carbone Cancer Center Clinical Trials Template
- For projects that are cancer related or are subject to UW Carbone Cancer Center review a cancer intervention oriented template is available through the Cancer Center’s Clinical Research Central Office here.
UW IRB Office Templates
- A Biomedical Research Protocol and Registry and Repositories Protocol are available from the UW IRBs Office here along with worksheets, checklists, and consent templates to aid with protocol development.
Pen-to-Paper Assistance
Protocol development assistance covering a wide range of therapeutic areas is available to UW-Madison faculty.
- For oncology research, contact the UW Carbone Cancer Center Clinical Research Central Office.
- For non-oncology research, contact UW Institute for Clinical and Translational Research (ICTR).
Additional Guidance & Resources
- HS IRB Protocol Guidance: outlines the elements that should be included in protocols for most research studies.
- Clinical Research Protocol Checklist: a tool to help verify that a protocol complies with international quality standards (ICH GCP) for conducting clinical trials.
- SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials): an international initiative to standardize the minimum content that must be included in a clinical trial protocol.