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Project operations and compliance support

eagle-i ID


Resource Type

  1. Support service


  1. Fee for service
  2. Resource Description
    * Cross functional coordination and training on applicable guidelines and regulations * Project start-up regulatory consultation * Project time line definition and management * Research Network Development -> Identify Collaborating Members -> Establish Communication Protocols -> Coordinate Collaboration Activities -> Facilitate Results Dissemination * Site Management -> Develop Regulatory Documentation -> Facilitate Protocol Training * Filing and maintenance of investigator-initiated INDs/IDEs * Informed consent review for compliance with ICH and HIPAA requirements * Safety reporting to regulatory authorities (U.S. and international)
  3. Service Provided by
    Clinical Research Computing Unit (Penn)
  4. Related Technique
    Clinical trial technique
Provenance Metadata About This Resource Record
  1. workflow state
  2. contributor
  3. created
  4. creator
    apizarro (Angel Pizarro)
  5. modified
Copyright © 2016 by the President and Fellows of Harvard College
The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016