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05 Mar Frequently Asked Questions About Medical Device Studies
FAQs About Medical Device Studies A device is an instrument, machine, implant, in vitro reagent, or other similar article that: is intended for use in the diagnosis, treatment, or prevention of disease – and – does not achieve its primary intended purpose through chemical action in the body or by being metabolized. An investigational device exemption (IDE) allows the investigational...05 Mar REDCap Tip of the Month
[otw_is sidebar=otw-sidebar-1] REDCap Tip of the Month...05 Mar REDCap Support
ITHS REDCap Support Policies Effective Date January 2020 The Institute of Translational Health Sciences (ITHS) at the University of Washington provides free of charge the use of REDCap™ (Research Electronic Data Capture) software as a service for ITHS member investigators and their teams to collect study data for research purposes, quality improvement, and operational support. REDCap should not be used...05 Mar Regulatory Monitoring
Regulatory Monitoring ITHS offers clinical study monitoring to help investigators who are required by the Food and Drug Administration or their funding agency to have ongoing independent review of their research records. ITHS also offers auditing and quality assurance review services for departments and investigators who are interested in one-time data checks. The goal of these programs is to ensure...05 Mar Monitoring Services
Monitoring Services ITHS offers clinical study monitoring to help investigators who are required by FDA or their funding agency to have ongoing independent review of their research records. ITHS monitoring services helps clinical investigators to: Maintain compliance with international, federal, state, local, institutional, and protocol-driven regulatory requirements for clinical research Ensure the accuracy of research data, including source document verification,...05 Mar Auditing and Quality Assurance Review Services
Auditing and Quality Assurance Review Services ITHS offers auditing and quality assurance review services for departments and investigators who are interested in one-time data checks. The goal of these programs is to ensure your study is run efficiently and effectively to produce high-quality data. ITHS Auditing & Quality Assurance Review Services helps departments and individual investigators to: Prepare for inspections...05 Mar Recruitment Resources
Recruitment Resources The purpose of clinical research is to gather data and answer questions that will be used to improve human health. However, slow participant accrual can result in studies closing prior to completion or remaining open past intended completion dates. These accrual challenges can thereby expose participants and volunteers to potential study risks without contributing any new knowledge to...
05 Mar Helpful Links
Helpful Links to Resources We have compiled links to a number of helpful links and resources in this section of our website. Please feel free to contact us if you would like to suggest other materials for us to add. Are you not finding the right facility or resource to meet your research needs? ITHS is pleased to offer a...