Tag Archive: Data Managers

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 […]

OpenSpecimen Tracking


OpenSpecimen is a Biospecimen Information Management System that is a scalable solution for a biorepository which meets the needs of a broad group of investigators and biobanks.  At Johns Hopkins, OpenSpecimen is currently used in multiple departments, including several Precision Medicine Centers of Excellence (PMCOE). What We Offer: Annotation of research and clinical data Specimen Information Interfaced with Precision Medicine Query capability Specimen and Derivative Tracking Specimen Event Tracking Epic Patient Lookup-Enabled Bulk Load Capability for Legacy Data Security (Enterprise Servers/JHED Login) Open Source with strong user community Extensible Architecture for Future Interfaces Considered a “Tier A” best practice for […]

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 […]

Research Electronic Data Capture (REDCap)


Research Electronic Data Capture (REDCap) is a mature, secure web application for building and managing online surveys and databases.   Using REDCap’s stream-lined process for rapidly developing projects, you may create and design projects using the online method from your web browser using the Online Designer and/or the offline method by constructing a ‘data dictionary’ template file in Microsoft Excel, which can be later uploaded into REDCap. Both surveys and databases (or a mixture of the two) can be built using these methods. REDCap Provides: automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, […]

Qualtrics Survey


Qualtrics is the world’s leading enterprise survey company, used by 1,300 colleges and universities worldwide, including every major university in the United States. Qualtrics makes it easy to create and distribute engaging surveys. It is FREE for use by all School of Medicine faculty, students and staff for research, evaluations, event registration and more. Surveys can be created and distributed by anyone with a current university login. In order to protect sensitive data, please use Qualtrics instead of Survey Monkey for your surveys. Beyond regular surveys, Qualtrics provides a rich set of features, including the ability to support: Sharing survey design and […]

SAFE Desktop


Request a SAFE Desktop or Access to an Existing SAFE Folder SAFE, the Secure Analytic Framework Environment (formerly called the Secure Data Desktop/SDD), is a virtual desktop that provides Johns Hopkins Medicine investigators (whether engaged in research or other data-intensive activities) with a secure environment to analyze and share sensitive data (e.g. PHI, PII) with colleagues. Top Features Software: the SAFE is installed with productivity software such as Microsoft Word and Excel, as well as statistical software, including SAS, Stata, R, R Studio, and Python. Other software applications can be installed for investigators willing to cover the licensing fees. Data […]

Epic Star Data Warehouse


The Star Data Warehouse is an analytical healthcare database that brings together Epic and non-Epic data, such as patient satisfaction information, in one simplified reporting database to vastly improve query ease and efficiency of data extraction for a key subset of data in Epic. To learn more about the Star Data Warehouse implementation at Johns Hopkins Medicine, please visit the the JHM SDW website. Please note, this is an internal website, visible only on the Hopkins network. Benefits Epic and non-Epic data in one place. Information from outside of Epic next to Epic data can be used to create reports […]

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 […]

Data and Safety Monitoring Plans and FDA Audits


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. Guidance Documents Guidance for Data and Safety Monitoring Plans FDA Audit Preparation Resource and Checklist Inquiries and Requests for Support Please submit an ICTR Connection Request.

Drug and Device Resources Disclaimer


The regulatory guidances, templates, and other materials provided at this site are available to the public and are for researchers to use with appropriate acknowledgement of source material. All material provided on this site is for informational purposes only. The Johns Hopkins Institute for Clinical and Translational Research makes no representations as to the accuracy, completeness, correctness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use.