ICTR

The Johns Hopkins Institute for Clinical and Translational Research

Call for Nominations: UHI Henrietta Lacks Memorial Award

The Johns Hopkins Urban Health Institute (UHI) is now accepting nominations for the Henrietta Lacks Memorial Award.  Nominations are due by Wednesday, July 31, 2013.

Programs that have been sustained for a minimum of three years and include at least one community organization and at least one Johns Hopkins faculty member, staff member, or group are eligible for the $15,000 award.  The award will be given to the community entity that is the central partner in that relationship.

Click here to download the call for nominations.http://ictr.johnshopkins.edu/wp-includes/js/tinymce/plugins/wordpress/img/trans.gif

This award was established by the Johns Hopkins Urban Health Institute to honor exceptional collaborations between community and Johns Hopkins University partners working together to improve the health and well-being of the city of Baltimore.

The Henrietta Lacks Memorial Award, named in recognition of Henrietta Lacks, highlights the importance of community-university collaborations, recognizes the accomplishments which can be achieved by such partnerships, and continues to support the efforts of the partnership.

FDA Seeks Research Partners to Advance Regulatory Science

The Food and Drug Administration (FDA) is soliciting research and development to support regulatory science and innovation.  The FDA  anticipates that research and development activities awarded under this Broad Agency Announcement will serve to advance scientific knowledge to accomplish its mission to protect and promote the health of the nation. This announcement is open to all responsible sources, including academic institutions, single entities or teams from private sector organizations, government laboratories and federally funded research and development centers.

The award is continually open and valid for one year from the date of issue.

To view the entire funding announcement, including eligibility requirements and submission information, click the link below.

FDA Broad Agency Announcement (FDABAA-13-00119)

Health Care Innovation Award Information

Photo of Dr. Daniel Ford

Dear Colleagues,

Thank you to everyone who has responded so enthusiastically about the second round of Health Care Innovation Awards, the $1 billion program from the Center for Medicare and Medicaid Services (CMS).  The full announcement can be viewed at  http://innovation.cms.gov/Files/x/HCIA-Two-FOA.pdf.  I am always impressed with the scope and number of new ideas generated by my colleagues, and this is no exception.  As we discussed in our meeting on May 29, 2013, it is going to be important that we coordinate our response to this program.  In order to do so, the ICTR has created a collaboration site on Microsoft SharePoint.  Anyone with a JHED ID can access the site via: https://collaborate.johnshopkins.edu/sites/ICTR/CMSInnovation

The SharePoint site contains links to information about this grant program, announcements, areas where you can ask questions and share answers, as well as places to discuss and upload your proposal ideas and receive feedback from your colleagues.  We can reduce the amount of questions and emails we send to the program contacts at CMS by simply pooling our questions here, and then posting the answers as we receive them on your behalf.  Although I will coordinate meetings to help aid potential applicants, online discussions and collaborations will be greatly beneficial.

Part of what makes this SharePoint site so powerful are the ways in which you can choose to interact with it.  You can set the site to email you when a particular piece of content changes, or when a new item is added to a list, or a new document is uploaded or changed.  That way, you don’t need to keep checking back on the site, but instead can receive information via email about when the site has changed.  If you use Microsoft Outlook, you can pull the events from the site’s calendar right onto your own calendar, so you’re always aware of new deadlines or meetings as they’re scheduled.  We have included a few documents on the site to help you learn about some of these basic tasks.  Look for the SharePoint Help Documents link on the left toolbar.  I hope you find the SharePoint website helpful as you prepare your application.

The next Health Care Innovation meeting will occur on Tuesday, June 11 at 5pm in on Tilghman Auditorium.  This meeting will focus on the required application financial model and cost of care savings.

Click here to view information on Johns Hopkins award recipients from Round One.

Thank You,

Daniel E. Ford, MD, MPH
Vice Dean for Clinical Investigation
Director, Institute for Translational and Clinical Research
School of Medicine

New Templates and Guidances Available from the ICTR Drug and Device Resource Service

The ICTR Drug and Device Resource Service (DDRS) provides Johns Hopkins University investigators and project teams access to resources needed to help manage the development and use of investigational drugs and devices in research. The DDRS maintains a free repository of regulatory knowledge, guidances, reporting documents, and useful templates. New resources are now available including:

  • FDA Audit Preparation Guidance and Checklist
  • Letter of Authorization (Right of Reference) Guidances for INDs and Drug Master Files
  • Letter of Authorization Guidance for 510(k) and PMA Devices

If you or your principal investigator are working with an investigational drug or device and are in need of guidance with regard to navigation of FDA regulations and required submissions, please visit the ICTR DDRS website at http://ictr.johnshopkins.edu/DDRS.

 

Call for Applications: Study Coordinator Apprenticeship and Mentoring Program (SCAMP)

Applications are now being accepted for the second cohort of study coordinator apprentices for the SCAMP. SCAMP is a two year intensive internship program that trains inexperienced individuals to become study coordinators. This unique program will provide apprentices with structured education and training, utilizing the Johns Hopkins and ICTR educational programs, clinical infrastructure and expert consultative resources. Apprentices will complete hands-on learning rotations shadowing experienced study coordinators and clinic staff. They will also gain firsthand experience as a study coordinator for study groups throughout the Johns Hopkins Institution.

The deadline to submit applications is June 15, 2013. Interviews will be held in July and job offers will be made in August with an anticipated start date of September 2, 2013.

To apply, download the application here.

Completed applications should be emailed to SCAMP@jhmi.edu.

For more information click here or contact Stephanie Swords, SCAMP Program Manager at SCAMP@jhmi.edu or 410-502-3296.

Epic 2012 and Clinical Research

With the roll-out of Epic 2012 fast approaching, there are significant questions throughout the institution about how this new system will intersect with clinical research operations. And because so much of this project implementation is purely clinical in nature, it’s been difficult to find answers to your questions through the widely-published routes.

The ICTR is offering information sessions aimed at giving study teams the information they need to understand how Epic will impact their research operations, and what they need to do to be prepared. These hour-long sessions will be held on:

  • Thursday, February 21, 2:00 pm, Hurd Hall
  • Wednesday, February 27, 1:00 pm, Hurd Hall
  • Thursday, March 7, 9:00 am, Hurd Hall
  • Friday, March 15, 10:00 am, Asthma and Allergy Center Auditorium, Bayview Campus

In these sessions, we’ll answer questions like:

  • What part of Epic goes live when?
  • How might my research practice change with Epic?
  • What existing systems will Epic replace?
  • What do I need to do now to make sure my research study continues smoothly under Epic?
  • How do I get trained and gain access to Epic? What role do I need in Epic?

The slide set from these sessions, which contains step-by-step instructions for how to request access to Epic and register for training courses, can be found here:

Epic Information

Henrietta Lacks School Visits Make Local News

A recent article in the Baltimore Sun highlights one of the many ways that Johns Hopkins, through the ICTR, honors the memory of Henrietta Lacks. Throughout the year, the ICTR and the Johns Hopkins Government and Community Affairs Office host visits by students from local schools, who come to learn about Mrs. Lacks and the extraordinary contribution her cells have made to medical science.

In addition to dozens of these school visits each year, Johns Hopkins Medicine and the ICTR continue to promote the legacy of Mrs. Lacks through the annual Henrietta Lacks Memorial Lecture, the Johns Hopkins Urban Health Institute’s Henrietta Lacks Memorial Award, the Henrietta Lacks Dunbar Health Sciences Scholarship, and a tile featuring Mrs. Lacks in the hospital’s new timeline display, honoring Hopkins pioneers of medicine.

Citing the ICTR in Publications

All publications resulting from research using any ICTR resource, including Clinical Research Units, ATIP funding, and/or consulting services, should cite the ICTR grant as a contributing source of support. When publishing articles related to this research, please include the following citation:

“This publication was made possible by the Johns Hopkins Institute for Clinical and Translational Research (ICTR) which is funded in part by Grant Number UL1 TR 000424-06 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the Johns Hopkins ICTR, NCATS or NIH.”

Thank you for your cooperation in acknowledging the ICTR’s support in your publications.

Call for Applications: Clinical Research Scholars Program

Applications are now being accepted for the Johns Hopkins Clinical Research Scholars (KL2) Program, supporting clinical research training and career development of outstanding post-doctoral fellows and junior faculty dedicated to a career in clinical investigation. The deadline to submit your completed application is April 1, 2013, 5:00PM EST.

To apply, please visit http://jhcrs.jhmi.edu. For more information regarding eligibility, funding and program requirements, please visit http://www.hopkinsmedicine.org/clinicalresearchscholars or contact Gregory Thornton, JHCRS Program Manager, at gthornton@jhmi.edu or 410-614-3997.

There will be information sessions on Friday, March 1 from 12 Noon-1PM and Tuesday, March 5 from 5:00-6:00PM in the Neil R. Powe Conference Room (1-500Q) at 2024 E. Monument Street.

*PLEASE NOTE*: KL2 awards are contingent upon NIH funding and would likely start on October 1, 2013

JHCRN Message to Investigators

Photo of Dr. Dobs

Dear Clinical Research Investigators:

If you are interested in participating in clinical research projects, then the Johns Hopkins Clinical Research Network (JHCRN) would like to know about you.

The JHCRN is an integrated network of academic and community-based clinical researchers in Maryland, Washington DC, and Northern Virginia which includes Johns Hopkins Medicine, Anne Arundel Medical Center (AAMC), Greater Baltimore Medical Center (GBMC), INOVA Health System, and Peninsula Regional Medical Center (PRMC).

The purpose of the JHCRN is to expedite research projects throughout the participating institutions in the broad areas of diagnostics, treatment, disease prevention and health care services. This bridge between Hopkins and select community hospitals creates a collaborative system that ensures a seamless platform for conducting clinical research with a broader and more diverse pool of clinical investigators and patients for studies. We were established in 2009 within the Johns Hopkins Institute of Clinical and Translational Research (ICTR), under the paradigm of one contract, one IRB, and one budget for studies performed within the network.

The JHCRN maintains a directory of investigator information from all member institutions to match the investigator’s specialties and research interests with clinical research opportunities.

If you are interested in being contacted about possible research studies, please register at http://ictrweb.johnshopkins.edu/ictr/jhcrn/investigator.cfm.

To find out more about the JHCRN, please visit our website, http://ictr.johnshopkins.edu/JHCRN or download our brochure.

Please do not hesitate to contact me for any questions or concerns.

Sincerely,

Adrian Sandra Dobs, MD MHS
Director, Johns Hopkins Clinical Research Network
Professor of Medicine and Oncology
The Johns Hopkins University School of Medicine
Division of Endocrinology and Metabolism
1830 Monument Street, Suite 328
Baltimore, MD 21287
443.287.4000 Phone
410.955.8172 Fax