Tag Archive: Previous Clinical Resources

Drug Screening, Development & Analysis Units


The Drug Screening Library Unit maintains, distributes, and screens drug library (FDA approved) compounds.  This unit is ideal for re-purposing licensed drugs by screening activity against new targets. For more information, contact: Jun Liu, PhD Lab Leader 410-955-4619 | joliu@jhmi.edu The Drug Development Unit provides: Consultative support for early phase clinical drug development Protocol design and data analysis support Early phase clinical study support For more information, contact: Craig Hendrix, MD Lab Leader 410-955-9707 | chendrix@jhmi.edu The Drug Analysis Unit provides support for drug development activities to faculty and to solicit use by faculty of Core expertise and facilities. Activities include consultative … Continue reading

Program to Accelerate Clinical Research Using EPIC (PACE)


PACE was established to help clinical researchers take full advantage of tools within the EPIC Electronic Health Record system for their research projects. We design and build customized EPIC content for your project to enhance the efficiency and standardization of the data collection process and improve data quality. Potential applications of customized EPIC build are numerous, some typical scenarios include: Tools that help providers to collect discrete data on a population of interest (such as longitudinal studies). This may include documentation flowsheets and SmartForms as well SmartSets that help populate Epic data fields in a standardized way. It may also … Continue reading

Research Coordinator Support Service


The ICTR Research Coordinator Support Service (RCSS) is a pool of research coordinators that are available for hire on a part-time basis by Johns Hopkins researchers. These coordinators are able to handle a wide range of responsibilities, and the support can be customized to best fit the needs to each individuals’ research team.  The pool consists of study coordinator apprentices who are a part of the Study Coordinator Apprenticeship and Mentoring Program (SCAMP) and Research Coordinators. These coordinators are available as part of a fee for service program, which makes the process of finding a part-time coordinator easier, as well … Continue reading

Center for Clinical Trials Study Design Consulting Service


The ICTR provides members of the Johns Hopkins research community a consulting service on questions relating to study design and conduct of clinical trials, and meta-analysis of clinical trials. Faculty of the Center for Clinical Trials and Evidence Synthesis (CCTES) are available to meet with researchers to discuss their proposed research plan. Housed in the Department of Epidemiology in the Bloomberg School of Public Health, the interschool CCTES is dedicated to the promotion of clinical trials as a method of evaluation of treatments for health problems. The mission of the consulting service is to provide intellectual and methodological input into clinical … Continue reading

OpenSpecimen Tracking


OpenSpecimen (formerly caTissue) is a bio-bank management tool used to collect, manage, process, annotate and distribute bio-specimens and associated data to selected users.  At Johns Hopkins, OpenSpecimen is currently being used in Gastroenterology, Cardiology and Oncology. OpenSpecimen offers a comprehensive feature set, including: Biospecimen collection, inventory, and tracking Ability to track specimen events (thaws, spins, etc.) Customizable support for storage containers (i.e. freezers, shelves, racks, boxes, position) User-definable forms for patient, collection event, and specimen annotations Flexible specimen ordering and distribution workflows Graphical custom report builder Integrated bulk loading capabilities for existing data Support for multiple biorepositories and locations Mailing … 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

Qualtrics Survey


What is Qualtrics? 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. Qualtrics 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 … Continue reading

Center for Clinical Data Analysis (CCDA)


The Center for Clinical Data Analysis (CCDA) assists researchers with accessing clinical data for research purposes. The CCDA is staffed with experienced data analysts who will assist you with access to data while also helping you comply with Data Trust privacy and security regulations. Here is how it works:      

What Services Are Provided?

  1. Preliminary, anonymous data for feasibility, grant applications and statistical population sample-size estimates
  2. IRB-approved case-finding for study enrollment (mailings, phone solicitation), chart review, and cohort/case-control studies
  3. Natural Language Processing service–Text mining and information extraction methods to identify disease, medications, symptoms, and signs from clinical text, as well as artificial intelligence techniques for sentiment analysis, opinion mining, measuring cognitive ability, and exploring social determinants of health.
  4. Research data extracts
  5. Data de-identification services to confirm to HIPAA Privacy standards (link should be over HIPAA and be https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html
  6. Honest Broker services
  7. Assistance using Epic’s SlicerDicer self-service tool

Why is There a Charge?

We have built an infrastructure that enables data through a secure, repeatable process that meets your needs, the institution’s values, and applicable privacy and security laws and policies. We looked at how comparable research institutions met this demand, and determined to pursue this approach. Similar to the 20+ other service centers at JHU such as the Genetic Core, the Biological Repository, and the Training and Management Development programs, we have developed a no-profit, revenue neutral approach that aims to provide high quality, lowest possible cost service to the research community. This hourly cost includes analysts, database administrators, servers, software, and management.

Rates:

  • First two hours of guidance and feasibility – No Charge
  • Analysis and data extract services for IRB-approved research – $84/hour ($100/hr for senior staff)
  • Analysis and data extract services for quality improvement – $114/hr
  • Ongoing maintenance of established periodic extracts – factored into initial cost

Who Are Our Customers?

Our customers can include researchers’ IRB-approved research studies, including, but not limited to researchers from the School of Medicine, School of Public Health, and the School of Nursing.

 

Represents requests completed 7/1/2016-6/30/2017

 

 

 

What Data Sources Are Available?

Our team is comprised of trained data analysts with access to multiple data sources including Epic, CaseMix/Data Mart, EPR2020 (Electronic Patient Record), Clinical Research Management System (CRMS), and Sunrise Clinical Manager (POE).

What Data Do We Provide?

Frequently requested data elements include:

  • Demographic data (age, gender, race, ethnicity, contact information)
  • Encounters/Visits (dates/times, locations/clinics, visit providers)
  • Diagnoses (problem list, recorded at the encounter, billed)
  • Lab Results
  • Medications (ordered, administered, patient-reported)
  • Procedures (surgical, imaging, etc.)
  • Flowsheet variables (vitals, etc.)
  • Questionnaires (Depression screening, surveys)

What Data Is Available in Epic?

Data availability in Epic depends on many factors, including clinic/location, specific data elements, and Epic go live at each location. See the graphic below for a timeline of available data.

How Do I Get Started?

To get started you can submit a request to our team using the iLab portal (https://johnshopkins.corefacilities.org/service_center/3796?tab=requests).  Please click the login button on the top-right of the window; then, select “JHU user”.  The CCDA manager will contact you within two business days to schedule a brief intake meeting to discuss your specific requirements.

What Information Is Considered When Structuring a Request?

In order to prepare for your initial intake meeting, it is often helpful to consider the following components regarding the specific data elements of interest: who, what, when, where, and how often. Please see the graphic below for more information about how to turn your high concept into an actionable request!

 

How Can the CCDA Assist Me in Ensuring Compliance with IRB and Data Trust Best Practices?

As part of our Honest Broker responsibilities, the CCDA will only deliver data extracts to secure locations approved by the IRB and Data Trust. We recommend requesting a SAFE Virtual Desktop when specifying the location for PHI storage and analysis. The SAFE is a Windows 10 desktop installed with statistical software including R Studio, SAS, Stata, MS Office productivity suite (Excel, Word, Access), and Python. By using this virtual desktop, you can ensure that the data we provide will be secure.

For more information on data trust and the SAFE Desktop, please refer to the following other informational pages.

Data Trust Overview

SAFE Virtual Desktop

How Long Does a Project Usually Take?

As you can see in the graph below, a majority of the projects that the CCDA handles are small-medium sized, with a majority of time being spent on medium-large projects. The CCDA is happy to work with you no matter how complex your project is.

 

Represents requests completed 7/1/2016-6/30/2017

 

 

 

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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 … Continue reading

Clinical Research Management System (CRMS)


CRMS is a web-based tool designed to organize and streamline clinical research management. It is designed to improve communication among study team members, store subject enrollment information in a secure location, and run real-time reports. Accessible by JHED ID, CRMS supports electronic eligibility checklists, integrates with eIRB, and tracks signed consent forms. It is designed to improve communication among study team members, store subject enrollment information in a secure location, and run real-time reports. If you are already a CRMS user, you can access the software at http://research-prod.jhmi.edu/.

Pediatric Neuropsychological Testing


Neuropsychological testing, includes achievement tests, behavior checklists, measures of personality, developmental status, intelligence, executive function, language, visual spatial skills, and memory, are available to ICTR CRU investigators. Skilled psychologists are available to provide a broad range of testing, including assessments of children who are cognitively very limited; those less severely impaired; and learning disabled children and adults; and control groups.