JOHNS HOPKINS MEDICINE INSTITUTIONS:
- The Johns Hopkins Hospital, Baltimore, MD
- Johns Hopkins Bayview Hospital, Baltimore, MD
- Howard County General Hospital, Columbia, MD
- Sibley Memorial Hospital, Washington, DC
- Suburban Hospital, Bethesda, MD,
- All Children’s Hospital, St. Petersburg, FL
AFFILIATE MEMBER INSTITUTIONS:
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
We initiate introductions, aid in grant writing and, and help see your research through by providing:
- Access to a large and diverse pool of patients,
- Identification of local site collaborative investigator(s)
- Assistance in setting up meetings
- Provide information on the demographics, etc. of the population to be studied
- Assist in grant writing, providing information about the sites and their relevance
- Administrative help with arranging meetings, collecting biosketches and letters of support (draft, send, collect)
- Draft recruitment strategies, budget justification, resources, etc.
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.
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.
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.
The Johns Hopkins principal investigator and lead site investigator(s) communicate regularly about all study activities to ensure the quality and integrity of each study.
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.
No. Payment to affiliate sites is managed by JHU.
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).