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 at Maine Medical Center. Our staff works with the Research Community to provide the tools and guidance to assist in meeting all applicable requirements.
Questions? contact us at: sequr@mmc.org or (207) 661-4474
Standard Operating Procedures
Pre-2018 Common Rule (for studies initially approved on or before January 20, 2019)
2018 Common Rule (for studies initially approved on or after January 21, 2019)
Consultation Services
Our 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
- 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
Study Researcher Resources: Documents/Templates/ Policies
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
- Checklist of Activities for Pre-Study Qualification Visit
- NorDx Laboratory – Support for Clinical Research Study (Green Sheet)
- Operating Room Investigational Device Procedures
- Pre-study/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
- 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 Close
Good Clinical Practices Policies
Guidance Documents
- Clinical Research Coordinator (CRC) Orientation Manual
- Clincial Trial Case Histories
- Comparison of ICH and FDA Regulations
- Documenting Study Visits
- Informed Consent Guidance
- Investigator Manual
- Investigator Guidance
- Investigator Responsibilities Guidance
- Noncompliance: Addressing Research Noncompliance – Guidelines for Departments and Practices
- Procedure for Observation of the Informed Consent Process
- Protocol Template Guidance: Biomedical Research – General
- Protocol Template Guidance: Biomedical Research – Drug Device/Medical Intervention
- Protocol Template Guidance: Data Coordinating Center
- Protocol Template Guidance: Lead Coordinating Center
- Protocol Template Guidance: Qualitative Research Template
- Protocol Template Guidance: Social Science/ Behavorial/ Educational Research
- Regulatory File: Essential Documents
- Research Recordkeeping and Retention Requirements
- Research Record Keeping and Retention: Administrative Records Relating to Research
- Roles and Responsibilities Documentation
- Staff Signature Log Guidance
- Study Document Log Guidance
Physician Initiated Investigational New Drug (IND) or Device Exemption (IDE)
An Individual or group of individuals or medical center can be considered a sponsor for an investigation if they hold the IND or IDE. These studies are typically called Investigator Initiated Studies and may use an investigational drug or device or use an approved drug or device for investigational purposes.
The Research Education and Compliance Officer (rlamb@mmc.org) will consult with any individual or group which requires obtaining an IND or IDE prior to the launch of the project.
Do I need an IND/IDE to do my research?
Guidance Documents
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 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.
MaineHealth Office of Research Ethics & Compliance
509 Forest Ave
Portland, Maine 04101
207.661.4474
mmcrirb@mmc.org
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