SEQuR (Support of Education and Quality Improvement for Researchers) is committed to providing on-going support and services to the community of investigators and their staff. Our staff works with the MaineHealth research community to provide the tools and guidance to assist in meeting all applicable requirements.
Questions? Contact: firstname.lastname@example.org or (207) 661-4474
Standard Operating Procedures for the Human Research Protection Program (HRPP):
Study Researcher Resources
Study Documents & Templates
The study logs and templates are intended to help research teams organize study documents, document required information and track study procedures with the aim to prevent common study errors and mistakes.
Study Start Up
Study Start Up
- +Checklist of Activities for Pre-Study Qualification Visit
- +NorDx Laboratory – Support for Clinical Research Study
- +Operating Room Investigational Device Procedures
- +Prestudy/Qualification Visit Follow Up
- +Protocol Assessment Checklist
- +Research Use of an Investigational Device -Sign off Sheet
- +Roles and Responsibility Log
- +Staff Signature Log
- +Study Training Log
- +Training Documentation Log
- +Adverse Event Log
- +Communication Log
- +Delegation of Responsibility Log
- +Device Log
- +Drug Log
- +IRB Correspondence
- +Memo to File Template
- +Minor Protocol Deviation Documentation Log
- +Remuneration Receipt
- +Screening/ Enrollment Log
- +Study Visit Checklist
- +Study Document Checklist
- +Subject Eligbility Checklist
- +Study Guidance: E6(R2) Good Clinical Practice
The SEQuR staff can provide navigation for new investigators through the research or IND/IDE process including study specific services at startup or throughout the course of a study.
These services can include:
- +Onsite review (form)
- +IRB submission guidance
- +External audit preparation
- +Study consultation
- +Honest Broker Training
- +Topic specific in-services
- +Orientation of new research coordinators and new physicians sponsoring their own projects
- +Ongoing support and programming for professional development opportunities for research staff
- +Administrative support for the Maine Medical Center Scientific Review Committee (SRC)
- +Mentored Research Grant (MRG) program navigation
The Research Education and Compliance Office (RECOs) within SEQuR (Support of Education and Quality Improvement for Researchers) office aim to help ensure the well-being of humans involved in research.
Learn more about about the Post-Approval Monitoring Process and review FAQs.
Principal Investigator Responsibilities require the PI to create, maintain and properly store study files or regulatory binders that contain the required study documents as outline in the GCP SOP 1103 (and associated Guidance Documents) entitled “Regulatory files and Subject Records”.
The Regulatory Binder will help PIs and research staff, identify, maintain and organize study documents and correspondence in one central location.
- The binder dividers will assist you in creating a binder for each study.
- The guidance documents will assist you as you create the binder.
Training Opportunities & Resource Webinars
Click on the links below to access training resources:
ACRP Offers Free Courses to Members & Free On-Demand Webinars
Advarra Offers Several On-Demand Webinars
BU Research Professional Network (RPN) Workshops (click here to become a RPN member)
Free Corrective and Preventive Action (CAPA) Webinar – Reviews Root Cause Analysis Methods & Preventative Actions
MaineHealth Investigator Training
SOCRA Offers Courses Free to Members
SOCRA Offers Free Video Resources
Understanding FDA’S New Proposed Regulations on Human Subject Research & Impact on Clinical Trial Plans
WCG Webinar: The Great Resignation – Its Impact on Clinical Research & Where We Go from Here
MaineHealth Office of Research Ethics & Compliance
509 Forest Ave
Portland, Maine 04101