THEW Legal Agreements:
To access the data from the THEW or to share data with the THEW, your organization is invited to sign legal agreements in order to ensure : first, the data from the THEW is used following an approriate legal framework, and second, the data from the repository is aprropriately de-idendtified and fully HIPAA compliant.
- THEW Data Use Agreement in MS word format and in pdf format
- THEW Data Sharing Agreement (DSA)in in MS word format and in pdf format
The DSA is a template. We invite your organization to modify their content in order to fit your organization legal requirements. Submit your changes to us by sending them to administrator@thew-project.org.
[12/16/2009]: The Director of the THEW interviewed by Technology Review published by the MIT: here.
[11/11/2009]: New Research Center to Focus on Cardiac Safety and Innovation in Pharmaceutical Industry Today: here.
[6/11/2009]: University of of Rochester and FDA Partner for ECG Database, Drug Discovery & Development Magazine. More info here
[5/6/2009] FDA website Existing Partnerships FDA’s Public-Private Partnership Program: THEW
[03/28/2009] Public and Private part- nership to help determine Clinical Biomarker Utility in Applied Clinical Trials online.com.>here
[7/26/2010] Members: Angel Medical System Inc. has joined the THEW initiative. Angel Medical Systems develops and markets cardiac devices that provide heart monitoring, alerting, and data collection. Their AngelMed Guardian system is an iimplantable cardiac monitoring and alerting system that is designed to warn cardiac patients of potentially life-threatening heart conditions.
[7/12/2010] The THEW quoted in a recent issue of the Journal of the American College of Cardiology. In a reply to a correspondence from Dr. Verrier and Nieminen on the role of T-wave alternans in hospital monitoring for torsades de pointes, Dr. Drew quoted the THEW as " a less expensive (than prospective clinical trials) and immediate available research strategy ... to validate ECG monitoring algorithms." JACC Vol. 56, No 3., 23010, 238-42.
[1/13/2010] Members: The Oxford University Computing Laboratory is the first new member for year 2010. At the heart of computing and related interdisciplinary activity at Oxford, this centre focuses on research in computer science, numerical analysis, computational biology, quantum computation, computational linguistics, and information systems. The Computational Biology Group also plays a key role in interdisciplinary initiatives across the University, including the EU FP7 projects euHeart and PreDiCT.
[05/27/2008]: "THEW Beyond QT working Group" releases an ECG marker submission form designed in collaboration with the FDA.
NHLBI Support[12/13/2009]:The University of Rochester and the NHLBI enabled the creation of a "Center for Quantitative Electrocardiography and Cardiac Safety" (CES). Read more...
Agreement[05/27/2008] FDA: Dr. J. Woodcock (Director, CDER-FDA) and Dr. Norman Stockbridge (Director for the Division of Cardiovascular and Renal Products, CDER-FDA) signed a Letter of Agreement officially starting the partnership between the FDA and University of Rochester for the THEW initiative. More...