Category Archive: Child of Patient Safety & Reg.

Research Participant Advocacy Program

The Research Participant Advocacy Program offers consulting expertise on human subjects and regulatory issues, IRB applications, the informed consent process, study feasibility and good clinical practice (GCP). Our advocates serve as a resource to research teams and research participants by reviewing applications to the Clinical Research Unit to assure high standards for human subjects protections. Contact our team to review consent forms, protocol or data and safety monitoring plans. Advocates are available to provide: Information on how to administer the best consent Help with Good Clinical Practice (GCP’s) Assistance on how to report an unanticipated study event Guidance with assembling […]

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 and devices in research. The DDRS is comprised of an investigational drug, biologics, and device information repository (Resources). DDRS Consultation Service This service includes a complimentary eight-hour consultation for those seeking a higher level of assistance with managing the regulatory requirements of their research projects. For assistance, please submit an ICTR Connection Request . Read more. Drug and Device Resources The information resources compiled at the various links below are available […]