Category Archive: Child of Patient Safety & Reg.

Research Participant Satisfaction Survey Results


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 at Johns Hopkins within the last 6 months. The survey, adapted from Kost et al Clin Trans Sci 2014 Dec;7(6):430-40, asked a variety questions including why it is important for them to join a study and to rate the care they received from the research team. The response rate was 34%. This survey will be administered semi-yearly. To view the complete survey and results, visit: ictr.johnshopkins.edu/wp-content/uploads/2016/09/ICTR_Participant_Satisfaction-Final.pptx For … Continue reading

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 to improve the process The regulations and current performance gaps Resources and assistance available On March 16, 2017 the Program presented an updated ICTR Third Thursday information session incorporating the Final Rule, download the slides, or view the video. You may also find this one-page handout helpful Click the pages below to learn more:

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

Participant Recruitment & Retention Support


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 have been developed and offered in collaboration with experts in information technology, ethics, and patient- and community-engagement. Each year, workshops, hands on seminars, and customized support are provided to help researchers achieve their recruitment goals. Since its formation, over 1000 investigators and research teams have received recruitment training and support. This includes a broad range of federally funded, multi-site clinical trials and research programs funded … Continue reading

Community & Stakeholder Engagement


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 improving community health. Community Engaged Research Training We offer introductory and advanced training in community engaged research.  Training topics include:  Planning and evaluating community engagement in research; disseminating research findings to the public; building and sustaining research partnerships. All training is delivered by Johns Hopkins faculty and staff in collaboration with the Community Research Advisory Council. The council includes academic researchers, health care professionals and … 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.