Tag Archive: Clinical Research

Science: Out of the Box


Why is cancer so hard to treat—and what new strategies are researchers considering? What do cells do when their DNA gets tangled up? How do brain cells build connections to each other? Our researchers use toys to help answer these and other questions in the video series Science: Out of the Box.   Immunotherapy and Antibodies | Slaying Lung Cancer Medical oncologist Julie Brahmer, M.D., explains how immunotherapy works as a tool in treating lung cancer. Using toys and finger paints, she demonstrates how the immune system attacks cancer cells. Dr. Brahmer discusses why immunotherapy is a promising new treatment … Continue reading

Behavioral, Social and Systems Science


The Behavioral, Social, and Systems Science community is lead by co-leaders Felicia Hill-Briggs and Jill Marsteller. The Behavioral, Social, and Systems Science (BSSS) community is designed to create an academic home and collaborative community for diverse scientists from across Johns Hopkins University who are conducting research in the areas of health and behavior, biopsychosocial interactions, social and cultural factors in health, health systems and health services, health IT, and methodologies. The BSSS Community serves as a catalyst to stimulate highly innovative researchers and research programs that expand the translation and dissemination of this research, and facilitate new methodologies for solving … Continue reading

Proteomic Biomarker Development Program


Proteomics Facility couples mass spectrometry to one and two dimensional separations by column chromatography or gel electrophoresis to identify, quantify or characterize proteins and their post-translational modifications, that are present in complex protein extracts or isolated in solution, gel bands or spots from cells, tissues or body fluids. Metabolite profiling for small molecules from clinical samples Provides biomarker development support Marker verification, validation, qualification for clinical implementation Provides technology and analysis to maximizes coverage of key proteomes required for discovery Quantitative protein analysis methods including mass spectrometry and development of new technologies Click here to submit an ICTR Connection Request

Medicinal Chemistry Unit


The Medicinal Chemistry Unit synthesizes small molecule when it is not commercially available.  This unit also supports structure-activity relationship studies. For more information, contact David Meyers, PhD.   Click here to submit an ICTR Connection Request

Core for Clinical Research Data Acquisition (CCDA)


The Core for Clinical Research Data Acquisition (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 designed to improve communication among study team members.  CRMS has the following main features: Protocol information from eIRB2 Registry of study participants Management of study accruals Consent tracking Secure location for study-related documents Pre-configured and adhoc reports Multiple interfaces with Epic, including sending data to Epic about the study and the study participants CRMS must be used by studies which could result in a patient bill. It may also be used by retrospective studies to define the study cohort in order to facilitate data extraction from Epic … Continue reading

Information for Investigators


Welcome Investigators Capitalize on a dynamic community of investigators, institutional collaborations, rapid access to industry-sponsored studies, and a diverse patient population.  The JHCRN is positioned to help you conduct studies, identify new research opportunities, and facilitate academic-community hospital collaborations. Johns Hopkins University faculty interested in expanding their study outside of Hopkins to the JHCRN is encouraged to contact Dr. Adrian Dobs at adobs@jhmi.edu, or jhcrn@jhmi.edu to discuss how the network can assist Investigators with a letter of support and study conduct. Once an Investigator decides to pursue collaboration with the network, a Network Coordinator will be assigned to the Investigator … Continue reading

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.

Operant Performance Measures


State-of-the-art Operant Performance Measures are available to investigators through the NBRU at Kennedy Krieger Institute. Direct observation of behavior, conducted in areas that simulate naturalistic settings, is accomplished by the use of computers with accompanying customized software that allows for the simultaneous recording of up to twenty behaviors for real time analysis, including conditional probability calculations.

Pediatric Motion Analysis Laboratory


The Pediatric Motion Analysis Laboratory is available through the NBRU in the Kennedy Krieger Institute. The lab provides whole-body movement assessments that quantify discrete components of the mechanisms of movement and movement deficits and detect very small changes in performance over time or in response to treatment. Several techniques are used to quantify movement, including: three-dimensional tracking and reconstruction of movement kinematics, force plate recordings, recordings of muscle activity, and calculation of joint forces and torques.