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
This is an accordion element with a series of buttons that open and close related content panels.
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).
- Please email info@ictr.wisc.edu for access to the template (DOTX file type, 8/31/2019)
Therapeutic Clinical Trial: Behavioral & Social Science Interventions
- 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
- 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.
- 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.