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.

The Johns Hopkins Clinical Research Network is a regional translational research organization linking a preeminent academic medical center with a diverse network of community-based health care delivery systems. We collaborate with both the private and public sector to more rapidly and cost effectively expedite scientific discovery through clinical trials and comparative effectiveness research to improve the care and health of patients.

JOHNS HOPKINS MEDICINE INSTITUTIONS:

o The Johns Hopkins Hospital, Baltimore, MD
o Johns Hopkins Bayview Hospital, Baltimore, MD
o Howard County General Hospital, Columbia, MD
o Sibley Memorial Hospital, Washington, DC
o Suburban Hospital, Bethesda, MD,
o All Children’s Hospital, St. Petersburg, FL

AFFILIATE MEMBER INSTITUTIONS:

o Anne Arundel Medical Center, Annapolis , MD
o Greater Baltimore Medical Center, Towson, MD
o Inova Health System, Falls Church, VA
o Peninsula Regional Medical Center, Salisbury, MD
o Reading Hospital and Reading Health System, Reading, PA

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.

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

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

 

• 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.

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.

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.

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/.

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.

Yes. It is available upon request.

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.

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.

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.

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.

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).