25. Are There any Services Available to Assist Investigators with Ensuring Regulatory Compliance?
To further assist study sites, the office of Supporting Education and Quality in Research (SEQuR) at (207) 396-8242 provides ongoing support to investigators and their study staff, including:
- Routine On-site Reviews- At the request of the Principal Investigator, SEQuR conducts domestic and international routine onsite review of study documentation to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process.
- Directed Audits- Directed audits may be conducted in response to participant or sponsor complaints, request from HSPH institutional officials or IRB, or concern from government agencies (e.g., FDA, NIH, and OHRP).
- Education/Additional Training
- In-Service - SEQuR staff is available to conduct small group in-service sessions addressing a variety of topics relating to research compliance; Institutional, policy and good clinical practice.
- New Investigator/Research Coordinator Orientation - SEQuR is available to meet with new study staff (PIs, Coordinators, etc.) in order to familiarize them with policies and procedures with a focus on the IRB review and approval process.
- Scheduled Education Series - See the SEQuR link for schedule of the current offerings.
- Study Management Tools- SEQuR offers a variety of study management tools to assist research sites in maintaining and organizing essential study documents.