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05 Mar IDE Development Toolkit
IDE Development Toolkit This section will help faculty navigate the process of developing a Sponsor-Investigator IDE. For a comprehensive introduction to device development, please refer to: Kahan, Jonathan. Medical Device Development: Regulation and Law. Needham, MA: Barnett International, 2009. The information provided in the following links pertains to Class III devices, that is, devices with the greatest risk or those...05 Mar Investigational Device Development
Investigational Device Exemption (IDE) Applications for Sponsor-Investigators The IDE Development Process Overview The sponsor of a Significant Risk (SR) device study is required to submit an IDE application to the FDA. The IDE allows the investigational device to be used in a clinical study in order to collect the safety and effectiveness data required to support a marketing application. Step-by-Step...05 Mar Definitions of Clinical and Translational Research
Definitions of Clinical and Translational Research Clinical Research NIH defines human clinical research as research with human subjects that is: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies...05 Mar Mentoring Tools
Mentoring Tools 36 kBMentoring Checklist – List of topics to structure meetings11 kBMentoring Partnership Agreement – Put your commitment in writing161 kBOne Minute Mentor – Points to cover at each meeting29 kBDeveloping Leadership Skills – Case based presentation524 kBEffective Communication – Vital to mentor-mentee relationship208 kBLeadership Lab Book – Identify your leadership style17 kBTime Management Matrix – Helps to define...03 Mar Communication Skills
[otw_is sidebar=otw-sidebar-1] Communication Skills...
05 Mar Informatics Tools
Informatics Tools REDCap REDCap is a free, web-based application for Electronic Data Capture. REDCap software that is distributed through the REDCap consortium attempts to facilitate informatics support for clinical researchers and foster a collaborative network of institutional researchers who share and support REDCap as a common research tool. Learn More & Get Started LEAF Leaf is a self-service tool which...05 Mar Collaboration Tools
Collaboration Tools PubMed Tutorial Use the Advanced Search tools to find researchers via publications. 609 kBPubMed Tutorial NIH RePORTER Search for intramural and extramural NIH-funded research projects. 888 kBNIH RePORTER Tutorial SciVal Funding Tool View the worldwide searchable database of funding opportunities and funded projects. 953 kBSciVal Funding Tool Tutorial...03 Mar Tips + Strategies
[otw_is sidebar=otw-sidebar-1] Tips + Strategies...