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URMC  » CTSI » Research Help

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  • Research Navigator Program
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  • Customized Action Plan (CAP)
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Self-Guided Tools and Resources

The Research Navigator Program provides web-hosted informational material, including a number of tools to guide project activities and to provide customized checklists of activities.

Tools and information are developed to meet the needs of researchers. These resources will be regularly updated and additional tools and information will be added based on user feedback, changing needs and expansion of services. Currently available tools and information include:

• Customized Action Plan (CAP) An online resource that guides investigators through the elements of planning and operating a study and provides a checklist of required approvals and available services.
• Orientation to Requirements for FDA Investigational New Drug (IND) Application An online training course for investigators on the elements and requirements for filing an Investigational New Drug (IND) Application to the FDA.
• Orientation to Medical Devices and the Requirements for FDA Investigational Device Exemption (IDE) Application An online training course for investigators on the basics surrounding medical devices, their classification, regulation, and requirements for filing an Investigational Device Exemption (IDE) application with the FDA.
• Research Subject Advocacy Support for research teams for ensuring the safety of research participants, creating a Data and Safety Monitoring Plan, establishing an Informed Consent Process and addressing human subject protection concerns.
• Support for ClinicalTrials.gov Study Registration Support for research teams with registration and reporting of clinical research trials at ClinicalTrials.gov, including guidance on registration requirements, ClinicalTrials.gov account management and technical assistance with entry of study information.
• Support for FDA Regulatory Compliance Support for investigators with the navigation of and compliance with specific FDA-regulated processes, including research involving experimental drugs and devices, as well as pre-clinical laboratory studies.
• Support for Molecular Biology Analytics Support for software that performs genomic and proteomic data analysis. Provides training sessions and workshops for specific software of genomic and proteomic data.

 

NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.