Category Archive: Child of Patient Safety & Reg.

ClinicalTrials.gov Program


The ClinicalTrials.gov program will assist investigators with: 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 to improve the process Up-to-date information on institutional and federal policies Direct effort upon request (billable/hr.) March 5, 2018 our Program presented Helping Research Teams Address New NIH Application Requirements Around Clinical Trials at Turner Auditorium to faculty and staff.  You may download the slides, or view the video. On March 16, 2017 our program presented an updated ICTR Third Thursday information session incorporating the Final Rule. You may download … Continue reading

Research Ethics Consultation Service


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 during study development, conduct, analysis and publication. Our consultants offer ethical guidance on the following topics:  Determining appropriate interventions to include in studies; Maintaining confidentiality in recruitment; Using alternative approaches to informed consent; and Responding appropriately when an unforeseen event occurs during data collection. To place a Research Ethics Consulting Service request, complete and submit a Connection Request Form. To learn more about the service … Continue reading

Research Participant Advocacy 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 Participant Advocates serve as a resource to research teams and research participants The Research Participant Advocates review applications to the Clinical Research Unit to assure high standards for Human Subjects Protections. Call us to review your consent form, protocol or data and safety monitoring plan. Let us help you to prepare the best possible research plan. The Research Participant Advocates are a training resource … Continue reading

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) with a Project-Specific Consultation Service available for those who seek a higher level of assistance with management of the regulatory requirements of their research projects. *Please read the disclaimer. For assistance, please submit an ICTR Connection Request . To learn more about the consultation service and available resources, click the links below.