eagle-i The University of PennsylvaniaThe University of Pennsylvania
See it in Search
This page is a preview of the following resource. Continue onto eagle-i search using the button on the right to see the full record.

Clinical Research Support Office (CHOP)

eagle-i ID

http://eagle-i.itmat.upenn.edu/i/0000013a-bc4e-ecdd-d69a-d90d80000000

Resource Type

  1. Core Laboratory

Properties

  1. Resource Description
    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 <a href="mailto:hodgsonm@email.chop.edu">hodgsonm@email.chop.edu</a> with details for a fee quote.
  2. Additional Name
    CRSO
  3. Contact
    Hodgson, Matthew
  4. Affiliation
    The Children's Hospital of Philadelphia Research Institute
  5. Performs Technique
    Clinical trial technique
  6. Website(s)
    http://www.research.chop.edu/programs/crso/index.php
  7. Director
    Hodgson, Matthew
 
RDFRDF
 
Provenance Metadata About This Resource Record
  1. workflow state
    Published
  2. contributor
    fcoldren
  3. created
    2012-11-01T10:18:52.648-04:00
  4. creator
    fcoldren
  5. modified
    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