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Drug and Device Advisory Committee (DDAC) The Drug and Device Advisory Committee (DDAC) reviews proposed innovations and provides up to 8 hours of free consultation per project to discuss specific pre-clinical development plans, focusing on tasks needed to efficiently move the drug to the clinic according to FDA guidelines. The DDAC can also provide insight into associated costs and complications...

Preclinical Researcher Toolkit Regulatory Information Guidance for IRBs and Clinical Investigators FDA Information Sheets International Conference on Harmonisation – ICH Guidelines (PDF) FDA CBER – What’s New Case Studies of Existing Human Tissue Repositories Resources and Services FOI Services – Private library of unpublished FDA documents IDE and IND Applications ITHS has created templates, guidance, and FDA forms for Investigational...

REDCap Research Electronic Data Capture (REDCap) is a rapidly evolving web tool developed by researchers for researchers in the translational domain. REDCap features a high degree of customizability for your forms and advanced user right control. It also features free, unlimited survey functionality, a sophisticated export module with support for all the popular statistical programs, and supports HIPAA compliance. Access...

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This is a restricted resource. Please sign in below.

Access to this resource is restricted to a specific group of ITHS Members. Please sign in. Please note that you may still not be allowed to view the resource after signing in.

Not yet an ITHS member?
Members of ITHS are part of a unique catalyst that accelerates discoveries to practice. If you haven’t signed up for an ITHS membership yet, learn more and join us.

Lost your password?

Fecal microbiota transplantation (FMT), also known as a stool transplant, may soon be a treatment option for children afflicted with Crohn’s disease thanks to the work of a researcher at Seattle Children’s Hospital. Crohn’s is an inflammatory bowel disease (IBD) that is often accompanied by a variety of symptoms and health complications. Current treatment options are limited to maintaining remission...

The Institute of Translational Health Sciences extends its congratulations on a job well done to 12 University of Washington students as they conclude the ITHS summer-long TL1 Multidisciplinary Pre-doctoral Clinical Research Training Program. The goal of the TL1 program is to increase the number of well-trained clinician-scientists capable of assuming lead roles in the design and oversight of future interdisciplinary...

Formation of scar tissue in the human heart is one of the leading causes of heart failure, a condition for which there are very few treatment options. Dr. April Stempien-Otero, an Associate Professor of Medicine in the UW Division of Cardiology and Attending Physician at UW Medical Center, is seeking to add to these treatment options. She is studying the...

The latest version of REDCap (i.e., version 6.0.0) overhauled a number of the features that allow you to aggregate, query, and export the data in your project. This REDCap version also introduced a number of helpful functions that allow you to sort through unstructured data to create more dynamic reports. For example, you can now search or filter through all...

The Institute of Translational Health Sciences announced today the launch of REDCap Offline, a new standalone version of the popular REDCap electronic data capture tool. The Offline version of REDCap is designed to aid researchers in capturing data when they are operating without a reliable Internet connection, making it ideal for field-based research. REDCap Offline maintains the functionality to which...