Category Archive: Child of JHCRN

Events


Monday, November 7, 2016 The Changing Landscape in Multi-Center Clinical Research The Johns Hopkins Clinical Research Network of the Johns Hopkins Institute for Clinical and Translational Research is hosting a seminar, The Changing Landscape in Multi-Center Clinical Research on Monday, Nov. 7, from 3 to 5:00 p.m., in Tilghman Auditorium.  Precision Medicine, Big Data, Patient Centricity – What’s all the buzz?  How are all of these initiatives going to transform clinical research and impact the investigative site?  Attendees will learn the answers to these questions and more from international experts. The keynote speaker, Eric Peterson, Executive Director of the Duke … Continue reading

For Sponsors


The Johns Hopkins Clinical Research Network offers industry a unique opportunity to conduct clinical research studies in the Mid Atlantic U.S. region. The following Frequently Asked Questions are intended to provide information for sponsors.

2. Who should sponsors and CROs contact if interested in bringing a study to the JHCRN?

The Johns Hopkins Clinical Research Network can be contacted by any of the following:

• Website: http://ictr.johnshopkins.edu/service/JHCRN
• Phone: 443-287-4000
• E-mail: jhcrn@jhmi.edu
• Director: Dr. Adrian Dobs: adobs@jhmi.edu
• Co-director: Dr. John Niederhuber: John.Niederhuber@inova.org.

3. What information should sponsors and CROs provide for the JHCRN to consider a study?

a. Study information (title, synopsis, patient population, eligibility criteria),
b. Funding information (if available),
c. Confidentiality Disclosure Agreement (CDA) template, and
d. Feasibility questionnaire.

4. How do JHCRN sites decide which studies they would like to participate in?

Each site will review study materials and make a decision regarding their participation based on the following criteria:

• Study population,
• Site resources,
• Investigator interest and experience,
• Protocol complexity, and
• Funding

5. What are the benefits of using the JHCRN?

• One dedicated experienced Network Coordinator for each JHCRN site,
• Access to a large and diverse pool of patients,
• One prime contract with Johns Hopkins,
• One main IRB, Johns Hopkins Medicine IRB, and
• One budget.

6. What is the Network Coordinator role?

Each JHCRN site has an assigned network coordinator who liaisons between the Johns Hopkins investigator, JHCRN site investigator, and their respective research teams. Responsibilities include:

• Facilitating the identification, prioritization, and implementation of clinical trials jointly approved by JH and network site investigators,
• Developing and implementing effective workflow processes between JHU and the network site in opening research studies, and
• Serving as a main point of contact for both institutions.

7. How do sponsors and CROs identify a principal investigator for a study?

A JHCRN network coordinator can help you identify a JHU principal investigator. Coordinator contact information can be found at: http://ictr.johnshopkins.edu/clinical/clinical-resources/human-subjects-research-core/jhcrn/jhcrn-network-coordinators/.

8. Does each JHCRN site have its own principal investigator?

There is one principal investigator for each study who is a Johns Hopkins employee. A lead site investigator is designated at each JHCRN site who is accountable for local study oversight under the direction of the Johns Hopkins principal investigator.

9. Does the JHCRN have a site management plan?

Yes. It is available upon request.

10. How does the principal investigator oversee study conduct at JHCRN sites?

The Johns Hopkins principal investigator and lead site investigator(s) communicate regularly about all study activities to ensure quality and integrity of each study.

11. Who takes responsibility for reporting adverse events from the Network sites to IRB, sponsor, and other regulatory agencies?

The site investigator notifies the principal investigator (PI) of any event meeting expedited reporting requirements as soon as possible. Event reporting to sponsor will first be completed by the principal investigator or site investigator. The PI will determine this reporting responsibility at the onset of a study, and also report to the JHM IRB, and other regulatory agencies as required.

12. Who does the sponsor and CRO correspond with at the affiliate sites, the JHCRN network coordinator or research staff?

Prior to study start-up, the network coordinator will be the main point of contact to help research staff get started. The network coordinator may have some contact with the sponsor/CRO after start up, but it is preferred they correspond with the research staff directly.

13. Do sponsors and CROs negotiate budgets and contracts with each JHCRN site?

No. There is one budget and one contract between sponsor and JHU that includes costs for the JHU principal investigator and JHCRN site(s). A JHU budget specialist develops and negotiates all study budgets for the JHCRN.

15. Where does monitoring take place and where are regulatory documents kept?

Routine study monitoring occurs at both the main Johns Hopkins central site as well as at each participating JHCRN site. The sponsor’s monitor arranges visits with individual sites on mutually convenient dates. Regulatory documents are maintained by the PI’s team at Johns Hopkins for all participating JHCRN sites.

16. Who ensures research staff at JHCRN sites are appropriately trained in the conduct of human subjects’ research?

The Johns Hopkins Medicine IRB requires human subjects research compliance training, both initial and continuing, be completed by each investigator and other study team member(s).

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JHCRN Network Coordinators


Each member institution has a designated Network Coordinator, who acts as a primary liaison between JHU and that institution. The Coordinator facilitates the identification, prioritization, and implementation of clinical trials jointly approved by investigators at JHU and the network site. Network coordinators may be contacted for more information on the JHCRN. Sandra Schaefer, BSN, RN, OCN Inova Heath System sschaef5@jhmi.edu 410-209-7385 Melissa Gerstenhaber, RN, MAS, MSN, CCRC Anne Arundel Health System mgerste1@jhmi.edu 443-890-3503 Lynne Armiger, MSN, CRNP Peninsula Regional Medical Center lynne.armiger@jhmi.edu 443-827-1444 Jackie Lobien, RN BSN Capital Region Research – CAPRES jlobien@jhmi.edu 301-896-3122 Mary Ellen (Ellie) Alderfer, MSN Reading … Continue reading

JHCRN Educational Programs


Events and Lectures Successful Pharmaceutical Study Start-Up: Key Steps for Investigators (video) Presentations: Stephen Broadhead Lynne Armiger Frederick Luthardt Adrian Dobs Karen Roz Linda Post April 7, 2015 Clinical Trials Education Series: Understanding Patient-Centered Outcomes Research & Comparative Effectiveness Research Albert W. Wu, MD, MPH March 16, 2011 Auditing and Monitoring Clinical Trials Jacki M. Yonkers March 16, 2011 Johns Hopkins Clinical Research Network Charles M. Balch, MD, FACS, February 11, 2011 Clinical Trials Education Series: Toxicities, Adverse Events and the Monitoring Process Charles M. Balch, MD, FACS Elizabeth Ness, RN, MS February 08, 2011 Recruitment and Retention of Patients … Continue reading

Leadership


Johns Hopkins Leadership Adrian S. Dobs, MD, MHS Network Director John E. Niederhuber, MD Network Co-Director Vered Stearns, MD (Oncology) Associate Program Director Jim Potter (Informatics) Associate Program Director Romsai Tony Boonyasi, MD, MPH, FACP (Population Health) Population Health Sandra Schaefer, BSN, RN, OCN (INOVA) Network Coordinator Melissa Gerstenhaber, RN, MAS, MSN, CCRC (AAMC) Network Coordinator Lynne Armiger, MSN, CRNP (PRMC) Network Coordinator Mary Ellen Alderfer, MSN (RHS) Network Coordinator Chris Hackett, MA (AHN) Network Coordinator Jackie Lobien, RN, BSN (CAPRES) Network Coordinator Robyn Hinke Administrative Coordinator Janet L. Mighty, BS Pharm, MBA Pharmacy Support Services Anne Arundel Leadership Barry … 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

Advantages of the JHCRN


The JHCRN provides a unique collaborative research infrastructure that enhances the flow of scientific information and expands the capacity to conduct clinical and translational research.  By providing an integrated approach, the network is positioned to foster research collaborations across the entire continuum of healthcare and to facilitate new research partnerships.  All members of the JHCRN have invested in Electronic Health Records, which facilitates access for patients and researchers alike. Single Principal Investigator: A Johns Hopkins University faculty member will function as the Principal Investigator (PI) of a network study.  A “Site Investigator” is designated at the non-Hopkins network sites.  The … Continue reading