Tag Archive: IRB

New Investigator’s Boot Camp


The program is designed to present the basics of the operations of the JHM IRB, while also providing orientation and how-to tips for preparing an IRB application. The agenda includes: Essentials of the JHM IRB’s structure and operations An overview of IRB help and other resources for investigators eIRB How-To Basics: from concept to application Investigator Expectations and Responsibilities An “Ask the IRB” Q&A experts panel To register, visit:  http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=499383 The course qualifies for in-person PI re-certification credit.

Trial Innovation Network


The Trial Innovation Network (TIN) is a collaborative initiative within the CTSA Program. It is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TIC) and the Recruitment Innovation Center (RIC). The TIN is designed to support innovation in multi-center clinical trials and studies. The vision of the TIN is to innovatively address critical roadblocks in multi-center clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The TIN is a collaborative national group that focuses on operational innovation, operational excellence and collaboration and will leverage the expertise and resources of the CTSA Program. The TIN … Continue reading

Data Management Advisory Board


The ICTR Data Management Advisory Board is designed to focus on data management within clinical research studies, including ways in which data management impacts study efficiency and the value of the data for both primary and secondary uses. Within Johns Hopkins there are a wide range of approaches to data management, with most of the responsibility centered within the individual studies. There are a few centers of expertise related to database management that have not generally met with each other or collaborated with each other to create institutional approaches and standards. The Data Management Advisory Board will work to answer … Continue reading

Regulatory Support


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 … Continue reading

Chesapeake Regional Information System for our Patients (CRISP) Database


Chesapeake Regional Information System for our Patients (CRISP) CRISP is a regional health information exchange (HIE) serving Maryland and the District of Columbia. This a non-profit organization is advised by a wide range of stakeholders who are responsible for healthcare throughout the region. CRISP has been formally designated as Maryland’s statewide health information exchange by the Maryland Health Care Commission. Health information exchange allows clinical information to move electronically among disparate health information systems. The goal of the HIE is to deliver the right health information to the right place at the right time – providing safer, timelier, efficient, effective, … Continue reading

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.) Please see the following publication, supported by the ICTR, detailing survey results of academic organizations: Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander C, Omar A, Ford DE, on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee.  Clinical trial registration … Continue reading

Protection of Patient Data


Johns Hopkins has multiple IT policies regarding the protection of patient data. Diana Gumas, Senior Director for Clinical Research Information Technology, is responsible for working with the Johns Hopkins Medicine Data Trust, the Institutional Review Boards, and the clinical research community to facilitate compliance with policies and address and resolve special data protection needs. The goals of our data protection policies are to ensure compliance with all applicable federal, state, and local law; to safeguard and protect all IT Resources from anything other than authorized and intended use; and to provide protection to academic, clinical, financial, research, and all other … 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

Data Managers Interest Group


Data managers are an integral part of most research teams, and their services have a profound impact on the quality and efficiency of the research process. The goal of this group, formed at the recommendation of the ICTR Data Management Advisory Board, is to create an environment where data managers from throughout Johns Hopkins can meet to share expertise and discuss the challenges of their unique roles in the research enterprise. If you wish to subscribe to the Data Managers Interest Group listserv, click on the link below and select “Subscribe” from the menu on the left side of the … Continue reading

Advantages of the JHCRN


The JHCRN provides a unique collaborative research infrastructure that enhances the flow of scientific information and expands the capacity to conduct clinical and translational research.  By providing an integrated approach, the network is positioned to foster research collaborations across the entire continuum of healthcare and to facilitate new research partnerships.  All members of the JHCRN have invested in Electronic Health Records, which facilitates access for patients and researchers alike. Single Principal Investigator: A Johns Hopkins University faculty member will function as the Principal Investigator (PI) of a network study.  A “Site Investigator” is designated at the non-Hopkins network sites.  The … Continue reading

Science of Clinical Investigation (SOCI) Training Program


The Science of Clinical Investigation (SOCI) Training Program is designed to prepare clinicians and other biological scientists to participate in multidisciplinary clinical research.  Courses are offered on-site and online. Translational clinical research requires a team that can design, analyze, interpret, and implement clinical studies in compliance with ethical and regulatory norms.  Develop this expertise and become a leader in clinical research with the SOCI training program. The SOCI program contains both onsite and online courses including: Database Design and Implementation in Clinical Research Ethical and Regulatory Issues in Clinical Research Design of Clinical Studies Quantitative Analysis of Clinical Data Outcomes … Continue reading