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 were developed for the most common investigator-initiated study designs with the goal of generating high-quality protocols and expediting regulatory approval. These optional templates are 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.
- The UW Investigator Manual describes when stand-alone protocols are required for IRB review and provides general protocol guidelines.
- 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
This is an accordion element with a series of buttons that open and close related content panels.
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.
Individualized Guidance
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 ICTR’s Protocol Development Program.
Additional Resources
- 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.