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 […]

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 […]

ClinicalTrials.gov Program


The ClinicalTrials.gov program assists 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.) Resources: BioMed Central 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 and reporting: […]

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 […]

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 […]

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 […]

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 […]

Applying to Use the CRUs


All investigators must submit an application to a Johns Hopkins Institutional Review Board (IRB) before beginning their ICTR Clinical Research Units (CRUs) application. There are two ways to submit an application to the ICTR Clinical Research Units (CRUs)– one method applies if you are using the School of Medicine eIRB system, while the second applies if you have submitted to another Johns Hopkins IRB. Please read through the materials below. If you need assistance with your budget before you apply, please contact Shernice Madison (smadison@jhu.edu, 410-550-7033) or Nicole Cooper (ncooper2@jhmi.edu, 410-550-1880).   First Method: For investigators who apply to the […]