HRPPQA (Human Research Protection Program Quality Assurance) 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: hrppQA@mainehealth.org or (207) 661-4474
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
Study Management
Study Management
- +Adverse Event Log
- +Communication Log
- +Delegation of Responsibility Log
- +Device Log
- +Drug Log
- + Investigator Self-Assessment (Subjects)
- +Investigator Self-Assessment (Regulatory)
- +IRB Correspondence
- +Memo to File Template
- +Protocol Deviation Log
- +Remuneration Receipt
- +Screening/ Enrollment Log
- +Study Visit Checklist
- +Study Document Checklist
- +Subject Eligibility Checklist
- +Study Guidance: E6(R3) Good Clinical Practice
Study Close
HRPPQA Services
- +Onsite review (form)
- +External audit preparation
- +Study consultation
- +Honest Broker Training
- +Topic specific in-services
- +Orientation of new researchers sponsoring their own projects
- +Ongoing support and programming for professional development opportunities for research staff
- +Administrative support for the MaineHealth Maine Medical Center Scientific Review Committee (SRC)
- +Mentored Research Grant (MRG) program navigation
Post-Approval Monitoring/Investigator
Compliance Reviews
The HRPPQA staff aim to help ensure the well-being of humans involved in research.
Learn more about the Post-Approval Monitoring Process and review FAQs.
Regulatory Binder
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 ICH E6(R3) Good Clinical Practice.
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.
Research Compliance Office
hrppIRB@mainehealth.org
207.661.4474
Do you have an interest in volunteering for research studies? Learn More