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How We Can Help: EQuIP Services
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In September 2007, the Education and Quality Improvment Program (EQuIP) expanded their services. Please review the complete list of EQuIP's services, outlined below and in the brochure, that the program is now able to provide to the clinical research community at Children's Hospital Boston.
Please contact EQuIP staff (5-7052) for more information or to request any of these services.
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A one-time, confidential, full or partial review of on-going studies to ensure compliance with applicable regulations and policies, and to evaluate study conduct, organization, record-keeping and documentation. The EQuIP office aims to help investigators implement tools and strategies to improve identified problem areas. Reviews are required when randomly selected or IRB-requested, but may be voluntarily requested by PI/staff (e.g. ensure compliance, during staff changes, to prepare for outside audit).
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At any time prior to initiating a study, upon request, the EQuIP office will review any study start-up materials (e.g. regulatory binder, case report forms) and will work with the PI/staff to identify the regulations and policies applicable to the study. When possible, the EQuIP office will provide educational materials/references, support and study tools.
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New Investigators (conducting clinical research for the first time) and Transfer Investigators (conducting clinical research at CH for first time) are required to meet with the EQuIP office prior to IRB approval to review applicable resources, regulations and CH policies. If requested, may be combined with Study Pre-Review and Set-up.
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Sponsor-Investigators are required to meet with EQuIP prior to IRB approval to review their additional responsibilities as an IND/IDE holder.
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EQuIP office can provide on-going study monitoring for Sponsor-Investigators IND/IDE studies required by Federal regulations.
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Upon request, the EQuIP staff is available to present various topics about research compliance and good clinical practices (e.g. informed consent, study documentation, source documents)
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Educational initiatives and materials are continuously developed and disseminated to assist the research community conduct compliant research.
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