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Clinical Research Support Office (CHOP)

Director: Goldfarb, Jennifer

Summary:

The Clinical Research Support Office (CRSO) provides high quality services to assist investigators and study teams in the start-up, execution, and completion of clinical research studies.
The CRSO offers comprehensive support in the following areas:
Research Staffing
Clinical Trial Financial Management
CHOP Research Navigator
Clinical Trial Support
Contracting
Recruitment Enhancement
IND/IDE Support

Contact: Jennifer Goldfarb, Senior Director, 267-426-7909

Clinical Trial Support:
-- Provides services related to the support of clinical trials, including the implementation, training, and support of OnCore, an enterprise Clinical Trial Management System (CTMS).

Contracting:
Negotiates the following types of contracting agreements:
-- Industry-funded human subjects research (both industry-initiated and investigator-initiated)
-- Subcontracts from industry-funded human subjects research
-- Master agreements and Letters of Intent to pursue industry-funded human subjects research
-- eIND and sIND expanded access agreements

Recruitment Enhancement
REC services include:
-- Recruitment plan consultation and development
-- Facilitate recruitment opportunities across CHOP and UPenn
-- Identification of potential participants through the Electronic Health Record (HER)
-- Paper and electronic invitations to potential participants
-- Study advertising to all CHOP employees

Research Staffing
Clinical research professional staff with diverse backgrounds, education, and experience are available to help clinical investigators and teams. Our staff are experienced with many types of clinical research studies.
Available full or part-time, temporary or long-term.
Some examples of support provided include:
-- Full study coordination activities
-- Study start up (IRB, CTRB, and eTrack submissions)
-- Preparation of regulatory documents and consent forms
-- Subject recruiting and consenting
-- Data entry and management
-- Study visit coordination
-- Safety reporting

Clinical Trial Financial Management
CTFM provides financial management throughout the lifecycle of a clinical research study and assists in the following areas:
-- Budget preparation and negotiation
-- Research subject registration and study visit financials
-- Research procedure charge review
-- Sponsor invoicing
-- Grant close outs

Investigation New Drug/Investigational Device Exemption (IND/IDE) Support
Provides regulatory and operational support for CHOP physician-initiated FDA regulated clinical trials.
Services include:
-- Guidance on whether a drug/device is exempt from IND/IDE designation
-- Protocol development and review
-- FDA regulatory strategy, submissions, and reporting requirements
-- Training, education, tools, and resources
-- Maintenance of institutional records of FDA submissions

CHOP Research Navigator
Serves as a liaison that connects research teams to available research resources at the institute.
Assist with:
-- Addressing inquiries
-- Listening to your concerns
-- for your ideas
-- Disseminating relevant information across the institute
-- Proposing opportunities for process improvement and education

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

  • Clinical trials consultation service ( Support service )

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

  • 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.

  • Human subject recruitment support service ( Support service )

    The CRSO develops recruitment materials and recruitment plans.

  • 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

  • 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.

  • Protocol development service ( Support service )

    "The CTO assists investigators with developing protocols that include all aspects necessary for Children's Hospital's standard protocol templates. The protocol templates follow the typical NIH and industry multi-center protocol study formats and are Good Clinical Practices compliant."

    email request with details for 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.

  • 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.


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Last updated: 2019-10-08T14:23:21.169-04:00

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