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. to ensure compliance, during staff changes, to prepare for outside audit).
New Investigators (conducting clinical research for the first time) and Transfer Investigators (conducting clinical research at Children's for first time) are required to meet with the EQuIP office prior to IRB approval to review applicable resources, regulations and Children's policies.
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).
Educational initiatives and materials are continuously developed and disseminated to promote compliant research. For example, common Study Review Findings are shared to prevent repetition of errors as well as to promote best practices.
