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Clinical Research Support Office (CHOP)

Director: Hodgson, Matthew

Summary:

The Clinical Research Support Office (CRSO) is the central office for clinical research support services at CHOP. The CRSO provides leadership, administrative guidance, and support services to support both novice and experienced clinical investigators with investigator-initiated and industry-sponsored research projects. The CRSO’s core services include clinical research professionals who support operationalizing clinical research projects. These services include RNs, CRCs, and PMs to operationalize and manage clinical research projects; regulatory affairs professionals to prepare, submit, and manage INDs, IDEs, and other submissions to regulatory agencies and committees; contracting and legal professionals to negotiate agreements in support of clinical research; recruitment and marketing professionals to work with investigators to strategize, develop, and implement marketing and recruitment plans to facilitate enrollment into clinical research projects; and other business and administrative support.

The mission of the CRSO is to make it easier for the CHOP research community to conduct quality clinical research projects. The CRSO’s services include:

• Clinical research personnel (study coordinators, research nurses, program/project managers, clinical research supervisors) provide support to clinical investigators, enabling investigators to carry out all types of clinical research projects in a manner consistent with CHOP’s mission—excellent patient care, top-quality education, and innovative research. The CRSO assists with the start-up, execution, and completion of clinical research projects and ensures compliance with local and federal requirements. CRSO personnel are well-trained clinical research professionals who can be assigned to support any type of clinical research project.
• Regulatory affairs professionals provide regulatory guidance, operational support, and institutional oversight for clinical trials conducted under a CHOP sponsor-investigator IND/IDE. The CRSO also coordinates and submits regulatory correspondence to regulatory committees and agencies such as the IRB, FDA, and DSMBs.
• Contract administrators negotiate Clinical Trial Agreements (CTA) for industry-sponsored clinical research.
• Recruitment Enhancement Core (REC) collaborates with research teams to strategize, develop, and implement marketing and recruitment plans to increase enrollment into clinical research projects. The REC liaises with other clinical and research departments to leverage institutional biobanking and data repository resources with the goal of building a robust and efficient sample and data biorepository.
• Research navigation services guide and connect research personnel to answers, resources, and tools to facilitate clinical research. The navigator is available to assist investigators with any questions that arise during the design, start up, and execution of clinical research projects.
• Clinical research professionals will assist the research community with the development of clinical research budgets, operational review of investigator-initiated protocols, and other administrative-related activities.

Contact hodgsonm@email.chop.edu with details for a fee quote.

Affiliations:

People:

Resources:

Services

  • Additional regulatory submissions support service ( Support service )

    The CRSO supports submissions to the following Children's Hospital and University of Pennsylvania organizations:

    • Clinical and Translational Research Center
    • Radiology Review Committee
    • University of Pennsylvania Institutional Review Board
    • University of Pennsylvania Radiation Safety Committee
    • Children's Hospital departmental committees
    • Cardiac Research Review Committee
    • Pediatric Protocol Review and Monitoring Committee (Oncology)
    • Neonatology Review Committee
    • Anesthesiology Review Committee
    • Medical Device Committee

    email requests to hodgsonm@email.chop.edu with details for a fee quote

  • Clinical trials consultation service ( Support service )

    The CRSO offers consultation services regarding study feasibility, protocol development, study start-up, IRB submissions, audits, etc.

    email requests to hodgsonm@email.chop.edu with details for a fee quote

  • Document storage service ( Storage service )

    The CRSO assists study teams as they prepare documents for onsite or offsite storage after a study is completed. The actual cost of offsite storage is billed to the project or department.

    email requests to hodgsonm@email.chop.edu with details for a fee quote

  • Human subject recruitment support service ( Support service )

    The CRSO develops recruitment materials and recruitment plans.

    email requests to hodgsonm@email.chop.edu with details for a fee quote

  • Institutional Review Board submission service ( Support service )

    The CRSO staff assists investigators who are preparing the following study documents for submission to the Institutional Review Board:

    • Initial submission
    • Informed consent documents
    • Continuing reviews
    • Study completion requests
    • External/internal serious adverse events
    • Safety reports
    • Protocol modifications and amendments
    • Protocol deviations
    • Recruitment materials and advertising
    • Consent form translations

    email requests to hodgsonm@email.chop.edu with details for a fee quote

  • Investigational new drug or investigational device exemption application support service ( Support service )

    The CRSO IND/IDE Support Program guides and supports:

    • Investigators who are filing Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications
    • Investigators who are serving as a sponsor or investigator for either single- or multi-site projects
    • Sponsors or investigators who are completing FDA-mandated submission materials and meeting subsequent reporting and documentation requirements

    The office also works with The Research Institute’s leadership personnel on issues of risk and feasibility.

    email requests to hodgsonm@email.chop.edu with details for a fee quote

  • Study feasibility service ( Support service )

    The CRSO collaborates with investigators and sponsors to determine study feasibility. The staff reviews study protocols with investigators to identify clinical, logistical, and financial issues that may occur during the study. Study coordinators work with investigators and industry sponsors in pre-study site visits to evaluate if operational and enrollment goals are achievable.

    email requests to hodgsonm@email.chop.edu with details for a fee quote

  • Study placement service ( Support service )

    The CRSO assists industry or other academic centers by identifying potential site investigators at Children's Hospital. An investigator who would like to conduct a clinical trial or has been contacted by industry or another academic center to conduct a clinical trial may contact the CRSO for its assistance.

    email requests to hodgsonm@email.chop.edu with details for a fee quote


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Last updated: 2016-05-04T14:41:16.811-04:00

Copyright © 2016 by the President and Fellows of Harvard College
The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016