- Study Reviews
- Study Pre-Reviews and Prep
- New/Transfer Investigator Pre-Reviews
- Sponsor-Investigator (IND/IDE Holders) Pre-Review
- Study Monitoring for Sponsor-Investigators
- Educational Initiatives and Materials
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).
Study Pre-Reviews and Prep
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.
New/Transfer Investigator Pre-Reviews
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. If requested, may be combined with Study Pre-Review and Set-up.
Sponsor-Investigator (IND/IDE Holders) Pre-Review
Sponsor-Investigators are required to meet with EQuIP prior to IRB approval to review their additional responsibilities as an IND/IDE holder.
IND/IDE Sponsor-Investigator Responsibility Checklists: As an IND/IDE holder, the Sponsor-Investigator takes on additional responsibilities. The EQuIP office has developed a comprehensive checklist to outline the additional responsibilities sponsor-investigators hold.
IND PI/Sponsor Responsibilities
Significant Risk IDE PI/Sponsor Responsibilities
Non-Significant Risk IDE PI/Sponsor Responsibilities
Study Monitoring for Sponsor-Investigators
EQuIP office can provide on-going study monitoring for Sponsor-Investigators IND/IDE studies required by Federal regulations.
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
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.