The IITS-U team under the MSOM Executive Dean for Research has partnered with the Human Subject Research Office (HSRO) to offer a protocol writing tool to UM investigators writing their own clinical research study protocols.
Protocol Builder is a secure, cloud-based technology that can help you write research protocols faster and more easily. It provides organization, guidance, and collaboration tools for your observational or interventional research protocols.
To login or get started click here: University of Miami Protocol Builder Pro Application
The UM Protocol Builder application currently has 17 different protocol templates to choose from to customize your protocol to your type of clinical research study. The protocol templates have UM IRB & JHS required boilerplate text available to insert. We recommend that you check “Pre-populate all sample text” when you start a new protocol document. The current protocol templates are:
- Univ of Miami Behavioral Intervention (incl. benign behavioral intervention)
- Univ of Miami Biospecimen Collection
- Univ of Miami Chart Review Template
- Univ of Miami Interventional Behavioral
- Univ of Miami Interventional Combination
- Univ of Miami Interventional FDA Approved Drug/Biologic
- Univ of Miami Interventional Investigational New Drug/Biologic
- Univ of Miami Interventional Non-Significant Risk Device
- Univ of Miami Interventional Significant Risk Device
- Univ of Miami NIH and FDA Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
- Univ of Miami NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans
- Univ of Miami Non-Significant Risk Device
- Univ of Miami Observational Study of an FDA Regulated Product
- Univ of Miami Observational Study of Individual or Group Characteristics, Behavior or Human Factor Evaluation
- Univ of Miami QI project
- Univ of Miami Repository without use of Broad Consent
- Univ of Miami Social Behavioral