Category Archive: 2017 Programs and Resources

Program Highlights


Program highlights: 2.5 FTEs of dedicated staffing Nidhi Atri, M.D. Prince Nuamah, M.D. Anthony Keyes, MBA, PMP Statistical expertise Provided by the BEAD Core http://jhcchr.org/bead First 1-hour covered by the program Most concerns can be handled in the 1-hour consultation Additional time needed and costs can be discussed Study team assistance Registration Account creation and maintenance Initial registration -Required for Applicable Clinical Trials -NEW: required for any clinical trial receiving full or partial NIH funding PRS reviewer comments (now time-limited to 15 calendar days) Update reminders (required every 12 months regardless of changes) Results reporting Changes to PI/Study team (including when … Continue reading

Timeline


  Year Entity Event 1997 Congress 1st U.S. law to require trial registration (FDAMA) 2000 NIH Releases ClinicalTrials.gov website 2005 ICMJE Requires registration before enrollment 2006 WHO All clinical trials should be registered 2007 CMS PI must enroll qualifying clinical trials in ClinicalTrials.gov 2007 Congress Expanded registration, submission of results and adverse events, civil penalties (FDAAA) 2008 NIH Releases results database 2015 CMS Mandatory Reporting of Clinical Trial Number on Claims  

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

Truven Health MarketScan® Research Databases


The Truven Health MarketScan® Research Databases capture person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services. The data comes from a selection of large employers, health plans, and government and public organizations. The MarketScan Research Databases link paid claims and encounter data to detailed patient information across sites and types of providers and over time. The annual medical databases include private-sector health data from approximately 100 payers. Historically, more than 500 million claim records are available in the MarketScan databases. These databases represent the medical experience of insured employees and their dependents for active employees, … Continue reading

Future Charges For Clinical Research Unit Services


Effective May 2018 The National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), which supports the ICTR Clinical Research Units (CRUs) through its Clinical and Translational Science Award (CTSA) program, announced in 2014 that direct support of the CRUs will not be allowed for any new or re-competing CTSA awards.  Our CRUS have been a major source of support for investigators throughout Johns Hopkins and this change in policy will have a significant impact on our future ICTR operations.  This NCATS policy has already been implemented for the 18 CTSA “hubs” that received a new award … 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

Future Charges For CRU Services


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REDCap


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, Stata, R), as well as … Continue reading

Participant Recruitment Consultations


We provide consultation and coaching on the recruitment and retention of diverse research participants using evidence based and ‘field tested’ methods. Staff offer advice and guidance to help investigators and research staff identify and address recruitment barriers.  Our consultants have experience with technology and community-engaged recruitment strategies.  Below are two examples of our services Technology Based Recruitment   The Recruitment & Retention Consultants helped a research team recruit adults with chronic kidney disease by collaborating with the Center for Clinical Data Analtyics, experts in the use of electronic health records for recruitment.  For more information go to Technology Based Recruitment … Continue reading

Computational Biology Consulting Core


About Us The Computational Biology Consulting Core (CBCC) was created to offer state-of-the-art computational biology services to biomedical researchers at the Johns Hopkins University. The Core is under the direction of Steven Salzberg. It builds on the expertise of faculty in the Center for Computational Biology, using best practices and the latest validated technologies to design solutions targeted to researchers’ needs.   Analytical Services We offer comprehensive analyses of sequencing data for a variety of genomics and other sequencing-based experiments, some of which are listed below. We can handle most types of sequencing data, including Illumina, PacBio, 454, and Sanger … Continue reading

Questions about OpenSpecimen (FAQs)?


Does the OpenSpecimen Team offer storage for specimens?

The OpenSpecimen Team does not store specimens, but the following research cores have specimen storage facilities:

GRCF Core
Biorepository & Cell Center
https://grcf.jhmi.edu/biorepository-cell-center/
Director:  Melissa V. Olson, Ph.D.
410-955-6327, mvolson@jhu.edu

Johns Hopkins Biological Repository
Bloomberg School of Public Health
http://www.jhsph.edu/research/labs/biorepository/contact.html
Director: Dr Homayoon Farzadegan
410-955-3786, JHBRLab@jhsph.edu

Hopkins Conte Digestive Diseases Basic and Translational Research Core Center
http://jhugicc.org/GIConteCenter/pages/cores/translationalResearchEnhancementCore.html
Translational Research Enhancement Core (Biorepository)
Director: James J. Potter
410-614-0130, jpotter@jhmi.edu

Does OpenSpecimen support barcoding?

Yes. OpenSpecimen has a data entry field for barcode values. At this time, these values can be manually entered.  Study teams have used second-party barcode software (i.e. BarTender) to print barcoded labels using data exported from OpenSpecimen.

Is OpenSpecimen web-based or platform-dependent?

OpenSpecimen is web-based, and the JHU instance resides behind JHU’s firewall. OpenSpecimen can be accessed on nearly any platform, but is best viewed using Google Chrome or Mozilla Firefox.

How much does OpenSpecimen cost?

OpenSpecimen is free to use for JHU SOM investigators and their teams.

Can I use OpenSpecimen if I currently use another database to manage biospecimens?

Yes. The OpenSpecimen team can help migrate legacy biospecimen data from another database. OpenSpecimen has MS Excel-based forms used to upload legacy data, and the OpenSpecimen team can help with arranging legacy data to fit these forms.

Is OpenSpecimen integrated with Epic?

No, not currently. The OpenSpecimen team is working on integrating surgical pathology reports with the OpenSpecimen application to better facilitate annotation of specimens with specimen pathology diagnoses.

Who has Super Admin privileges and how secure is my data?

Only members of the OpenSpecimen Team have Super Admin privileges. Admin privileges can be granted to study PIs and other members of the study team at the discretion of the PI; additional users can be provisioned by the study team. Users can access data for their studies only.

Could you tell what open source means? What does that mean for our study?

OpenSpecimen is an open source web application developed by Krishagni Solutions, a software vendor. The application source code is freely available to download, install and even modify under the open source BSD 3-clause license (https://github.com/krishagni/openspecimen/blob/trunk/LICENSE.md). IT@JH has installed an instance of the OpenSpecimen application and underlying database on our own secure servers behind the Hopkins firewall. In other words, your data safely reside on JHU servers.

Is there somewhere I could test OpenSpecimen publicly?

Yes. A public demo site (non-JHU) is available for testing here: demo.openspecimen.org, and you will be prompted to sign up for an account. JHU has a Test instance available, and the OpenSpecimen Team would be glad to set up a demo with you and explain further.

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