Protocol Templates

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

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.

Additional Guidance & Resources