Download the template(s) of your choice. The template documents open as Word files; save as a Word file to begin drafting your protocol.
Contact April Firstencel at 216.286.2294 or firstname.lastname@example.org with any questions.
Biomedical Protocol Template
The following template is primarily designed for studies focused on cancer treatment regimens, with chemotherapy as the main component of the regimen. The template may be modified to address questions about hematology, radiotherapy or surgical oncology.
The template is a tool for investigators to ensure that all sections of the protocol are included in the document. It also contains links to the guidance documents with the boilerplate language for sections that are required in all protocols.
- Treatment Template
- Guidance Documents
- Before you Begin
- Treatment Schemas
- Protocol Summary
- Replacement of Subjects
- Eligibility Criteria
- Agent Administration and Dosing
- Dose Limiting Toxicity
- Dose Modification
- Adverse Events and Serious Adverse Events
- Drug Handling and Administration
- Correlative of Exploratory Studies
- Calendar and Study Parameters
- Solid Tumor Measurement of Effect
- CWRU Employee on Case CCC Study
All instructions in the template are highlighted in blue. Please review these instructions and address as applicable for your protocol.
Social-Behavioral Studies Protocol Template
The research protocol template for social-behavioral studies may be used for quality-of-life, psychosocial, epidemiological, genetic, and behavioral intervention studies.