Overview
A well-written clinical and translational research protocol is critical to successfully executing studies, ensuring regulatory compliance, protecting participants, and maintaining data integrity. ICTR provides individualized protocol development support with the goal of improving the quality of investigator-initiated clinical research and reducing the time from study conception to conduct.
Complimentary services are available to faculty planning an investigator-initiated clinical or translational research study (therapeutic, non-therapeutic, interventional and/or observational):
- A single point of contact, your navigator.
- Consultations customized for your project with your navigator.
- Help identifying next steps and working through challenges and barriers, including suggestions for assistive services (e.g., BERD, Bioinformatics, Recruitment and Retention, etc.), with meetings attended by the navigator (if preferred).
- Connections to a broad set of experts, resources, tools, and opportunities.
- Schedule a group Studio (a single meeting to gather experts’ advice on complex study issues).
- Guidance on study design.
- Assistance editing clinical research protocols.
- Identification of appropriate protocol templates that fulfill Institutional Review Board (IRB) or other regulatory agencies’ requirements for your study.
- Review of a protocol prior to IRB submission to ensure completeness.
- Guidance with submission to the UW Health/SMPH Research Operations Committee (UROC), and Scientific Review Committee (SRC) review processes.