Regulatory Compliance and 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 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 ...