Patient Safety & Regulatory Compliance/ Guidance

The ICTR offers education, expert advice and resources to better equip study teams to conduct research that is ethical, relevant and responsive to the interests of patients and research participants. Our Research Participant Advocacy program provides consulting on human subjects and regulatory issues, including IRB applications, the informed consent process, study feasibility and good clinical practices. Our advocates help to ensure the rights, safety, and well-being of participants. We also provide consultations to assist investigators in resolving ethical issues throughout the entire research process and tools to recruit study participants.

Our Drug and Device Resources Service provides tools needed to help manage the development and use of investigational drugs and devices in research. The service is available for those seeking a higher level of assistance with the management of the regulatory requirements of their research projects. The Research Navigators have a compilation of guidance documents and templates available by request.

Because all clinical trials funded in whole or in part by the National Institutes of Health (NIH) are required to be registered and reported, we provide investigators with instructions to stay in compliance through our ClinicalTrials.gov program.

The ClinicalTrials.gov program will assist investigators to learn: The ethical, scientific and legal reasons for clinical trials registration and reporting Which trials are required to be registered and the timelines Tips, tricks and helpful content ...

The Community Engagement Program of the Johns Hopkins Institute for Clinical and Translational Research aims to bring researchers, diverse communities, and stakeholders together to share their knowledge, skills and resources with a common goal of ...

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 ...

The Participant Recruitment & Retention Program of the Johns Hopkins Institute for Clinical and Translational Research, established in 2007, offers investigators and research teams training, consultation, and a toolkit of evidence-based, field-tested recruitment practices. Services ...

The goal of the Research Ethics Consultation Service is to help raise awareness of, and to assist investigators in resolving ethical issues throughout the entire research process.  Consults may be requested for ethical issues arising ...

The Research Participant Advocacy Program provides consulting expertise on human subjects and regulatory issues, including IRB applications, the informed consent process, study feasibility and good clinical practice (GCP). Contact us for quick expert help. The Research ...

In July 2016, the Johns Hopkins Institute for Clinical and Translational Research randomly selected 500 participants from the Clinical Research Management Services list to receive a survey by email if they were involved in a research study ...