Drug and Device Resource Service (DDRS)

The Drug and Device Resource Service (DDRS) provides Johns Hopkins University investigators and project teams access to resources needed to help manage the development and use of investigational drugs, biologics devices and software in clinical research.

The DDRS offers the following:

Consultation Service

This service includes a complimentary eight-hour consultation for those seeking help with managing the external (i.e. FDA) regulatory requirements of their research projects. For assistance, please submit an ICTR Connection Request .

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Information about complying with and managing the regulatory requirements for studies with investigational drugs, biologics, devices and software, are available outside of the DDRS Consultation Service, by emailing ICTR_Navigators@jhmi.edu. The materials provided are continually being updated to support current research needs but at this point includes the following informational sheets, templates, and forms which may be used for:

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The regulatory information sheets, templates, and other materials provided at this site are available for researchers to use with appropriate acknowledgement of source material. All material provided on this site is for informational purposes only. The Johns Hopkins Institute for Clinical and Translational Research makes no representations as to the accuracy, completeness, correctness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use.