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Resources to Assist Investigative Research researcher in the lab
 

Mission

To enable Johns Hopkins clinical investigators and research teams to push the boundaries of discovery by delivering exemplary support to develop, initiate and conduct clinical trials within the framework of human research participant protection and regulatory compliance.

Message from the Director

Investigational New Drug/Investigational Device Exemption Regulatory Program

The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program provides guidance to clinical investigators, sponsors, and sponsor-investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA in accordance with the institutional policy on Investigator-held INDs/IDEs.
For more information or questions: IND_IDEprogram@jh.edu

 

Additional Resources

  • Below is a checklist of information for industry-sponsored clinical trials. Printable checklists are also available. 

    1. Protocol Selection/Site Feasibility Assessment

    Confidentiality Disclosure Agreement (CDA): A CDA is an agreement between the study sponsor and the institution that governs the access and use of confidential information. The Office of Research Administration (ORA) will review and sign on behalf of the institution. Some sponsors will require this agreement be signed before the full protocol is provided.

    Study Consideration: Does the site have the patient population, staff, expertise, equipment etc. to conduct the study?

    • Necessary equipment to run the study per protocol is available
    • There is sufficient staff support and the staff are experienced and trained to run the particular study
    • The PI has time to devote to the management and oversight of the study
    • There are no conflicting studies which would impact enrollment
    • Available cohort of patients needed for the study
  • To identify the number of potential participants for a clinical trial, investigators can quickly access Epic SlicerDicer or TriNetX with more detailed information available through collaboration with the CCDA.

    • Epic SlicerDicer. Investigators with access to Epic can use Epic’s SlicerDicer to get rough patient counts. To find SlicerDicer in Epic, go to the Epic search bar and type in SlicerDicer. IRB approval is needed prior to using these data for recruitment or to conduct your research or publish.
    • TriNetX is a self-service web-based data exploration tool that helps clinical researchers to define a patient cohort using inclusion and exclusion criteria and to explore cohort attributes.
    • Core for Clinical Research Data Acquisition (CCDA). When investigators have sophisticated inclusion and exclusion criteria that cannot be satisfied by using SlicerDicer or TriNetX, we recommend that they contact the CCDA for assistance. Investigators receive 2 initial hours of service subsidized by the ICTR, during which we are often able to complete simple feasibility queries.
  • Process Summary

    PRA Initiation

    eIRB/CRSS have an integrated workspace in which all studies enter the CRSS workspace for PRA determination.

    Budget Development Request
    • IRB application must be started in order to obtain an IRB#.
    • Principal investigator (PI) sends a budget development request and the required documents to CRSS (CRSS@jhmi.edu ).
    • Study may remain in “Researcher Prep” until ready for full IRB submission
    CRSS Analyst Assigned
    • CRSS analyst is assigned
    • CRSS analyst require the following documentation:
      • Most recent protocol;
      • Draft contract and sponsor budget;
      • Proposed ICF cost language;
      • NOGA (if the study is government funded);
      • Investigator’s Brochure (IB) (if applicable); and
      • Any information regarding the FDA status of the investigational item(s) (if applicable).
    PRA Development
    CRSS Analysis
    • Training checked / Notifications sent
      • Clinical Research Billing Orientation (CRBO) – PI and consenting study team members [online available through MyLearning Website]
      • Clinical Research Management System (CRMS) - PI
    • Creates PRA Memo
    • PRA Billing Grid delineation of charges for items and services.
    Review and Approval
    • Draft PRA to PI/Research team for review. 

    PI may request/suggest revisions:

    1. Revision of the PRA in consultation with the PI as necessary.
    2. Revised draft(s) to the PI for review and approval.
    3. Process repeats until the PI approves the draft.

    When PI approval is granted:

    1. PI approved draft PRA forwarded to IRB.

    If budget development is requested, please send a message to CRSS@jhmi.edu

    • The budget will be developed using the PI approved PRA.
  • NDAs or CDAs must be submitted to the Office of Research Administration for negotiation.

    Email an editable version of the document to the ORA Sponsored Project Specialist assigned to your department. If no document is available, ORA has templates for use. Find your assigned ORA Sponsored Project Specialist.

    Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Sponsor; and identify the purpose of the NDA/CDA and your timeline.

  • Clinical trials agreements should be submitted to the Office of Research Administration as soon as they are received from the Sponsor. IRB approval is not required to begin CTA review and negotiations which should occur in parallel with the IRB review of the study. The clinical trial agreement must be submitted via COEUS with the Activity Type “Clinical Research.” For the COEUS submission, the IRB application number can be generated by initiating the IRB submission in eIRB but approval is not necessary to initiate the review.

    For an initial or original agreement, you will need the following documents:

    • Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
    • Supplemental Information Sheet (“SIS”) for Commercial Agreements
    • Proposed Budget, when applicable. No budget is required for unfunded studies.
    • Statement of Work or Scope of Work
    • IRB application number, if applicable (and other applicable compliance, like ISCRO). If the IRB approval is pending, please indicate. 
 

Our Team

  • Mark Sulkowski

    Director, Office of Clinical Trials

    Mark Sulkowski
  • TBN

    Administrative Director, Office of Clinical Trials

    TBN
  • Jackie Lobien

    Director, Clinical Research Program Operations and Capital Region Research (CAPRES)

    Jackie Lobien
  • Mont Brownlee

    Executive Director, Clinical Research Contracting

    Mont Brownlee
  • Karen Roz

    Director, Clinical Research Support Service

    Karen Roz
  • Liza Rodriguez

    Associate Director, Clinical Research Billing Compliance (CRBC)

    Liza Rodriguez
  • TBN

    Director, Johns Hopkins University IND/IDE Program

    TBN
  • TBN

    Director, Clinical Research Revenue Cycle

    TBN

Message from the Director

Mark Sulkowski

Welcome to the Johns Hopkins Office of Clinical Trials! I'm Dr. Mark Sulkowski, Professor of Medicine in the Division of Infectious Diseases, Department of Medicine, and the Senior Associate Dean for Clinical Trials in the School of Medicine. I'm thrilled to partner with Dr. Gail Daumit, the Vice Dean for Clinical Investigation, and Dr. Daniel Ford, director of the John Hopkins Institute for Clinical and Translational Medicine (ICTR) to transform the Johns Hopkins Medicine clinical trials ecosystem.

As an academic clinical investigator, I've partnered with colleagues at Johns Hopkins, other academic institutions, government agencies, and industry to lead clinical trials that revolutionized the treatment of people with chronic hepatitis C infection. These partnerships made a remarkable difference for people with hepatitis C by delivering curative treatment with minimal side effects. Clinical trials are central to ensuring that we improve the health of our patients and our population by advancing innovative therapies and strategies for the diagnosis prevention and treatment of disease.

The Johns Hopkins Office of Clinical Trials is a service organization committed to enabling John Hopkins clinical investigators and our patients to improve human health by pushing the boundaries of discovery through clinical trials. We're here to help and look forward to partnering with you!

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