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.

Tips

  • 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?

Templates Based on Study Design

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Therapeutic Clinical Trial: Drug/Device Interventions (version 8/31/19)

  • Intended for prospective clinical research that evaluates feasibility, efficacy, effectiveness, safety, tolerability and/or clinical usefulness of an investigational product.
  • Applicable for studies involving a drug, device, biologic, vaccine, software application, supplement, or medical food.
  • Suitable for FDA-regulated studies as well as those that do not require an Investigational New Drug (IND) or Investigational Device Exemption (IDE).
  • DOWNLOAD TEMPLATE

Therapeutic Clinical Trial: Behavioral & Social Science Interventions (Coming Soon!)

  • Intended for clinical trials that are testing a behavioral or social intervention or manipulation.
  • Slated for UW-Madison adaptation in 2019/2020.  In the meantime, please refer to the NIH’s Behavioral and Social Sciences Research Template.

Observational Research (Coming Soon!)

  • Intended for observational research in which there is no intervention
  • Appropriate for the following:
    • Cohort study: A type of longitudinal study in which individuals are are followed from identification of a risk factor forward in time.
    • Case-control study:  A type of retrospective study that compares individuals with a given condition or disease (the cases) and individuals without the condition or disease (the controls) with respect to antecedent factors.
    • Cross-sectional study:  A study that observes individuals at a single moment in time (e.g., on a single day, at a fixed time, at a single clinic visit).

Pen-to-Paper Assistance

Protocol development assistance covering a wide range of therapeutic areas is available to UW-Madison faculty.

Additional Guidance & Resources