Category Archive: 2017 Programs and Resources

Registering and Reporting

Why Register and Report? Commitment to research participants Scientific validity/transparency Ethical standards Responsible stewardship of federal funds Required by law (FDAAA) * NEW* Required for any clinical trial funded in full or in part by NIH Required by NCI Required for journal publication (ICMJE) Required for CMS Required by WHO Who is Responsible for Registering a Trial? The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be: The Sponsor of the clinical trial (as defined in section 21 CFR 50.3) who initiates the study.  The Johns Hopkins PI should consult […]

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 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 […]


  Year Entity Event 1997 Congress 1st U.S. law to require trial registration (FDAMA) 2000 NIH Releases website 2005 ICMJE Requires registration before enrollment 2006 WHO All clinical trials should be registered 2007 CMS PI must enroll qualifying clinical trials in 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 Program

The 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: […]

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, […]

Charges For Clinical Research Unit Services

Effective May 2018, Clinical Research Units are now operating using a service center model. 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 […]

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 […]

Future Charges For CRU Services

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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 […]

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 […]

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 and managed by Liliana Florea. 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 […]