We are 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.

Learn more about our Quality Improvement (QI) and Quality Assurance (QA) Program

Questions? contact us at: sequr@mmc.org or (207) 396-8128

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

Good Clinical Practices Policies

1100 On SOPs: Preparing, Maintaining and Training
1100A SOP Training Log
1100B SOP Review Log
1101 Study Planning and Preparation
1101A Protocol Assessment Checklist
1101B Checklist of Activities for Pre-Study Qualification Visit
1101C Pre-study/Qualification Visit Follow Up
1101D (1,2) Study Training Log Version 1 and Version 2
1101E Site Personnel Delegation of Responsibility
1101F CRC Communication
1102 Interactions with the IRB
1103 Regulatory Files and Subject Records
1104 Study Monitoring Procedure
1104A Accessing Charts Through Sunrise Clinical Manager and Sunrise Record Manager
1105 Study Closeout Procedure
1105A NorDx Study Deletion Form
1105B Study Closeout Checklist
1106 Investigational Drug/Device Accountability, Storage, Dispensing and Return
1106A Sample Device Accountability Log
1106B Sample Drug Accountability Log
1106C Research Use of an Investigational Device-  Sign off Sheet
1106D Operating Room Investigation Device Procedure
1107 Informed Consent Process
1107A Guidance for Investigators- Obtaining Informed Consent
1108 Subject Recruitment
1108A Email Notification- Research Subjects Admitted to the Hospital (Report Router)
1108B Screening/Enrollment Log
1109 Subject Management While on Study
1109A Guidance for Investigators -Study Subject Case History Documentation
1110 Reporting Adverse Events and Protocol Deviations/Violations and Unanticipated Problems
1110A Adverse Event Log
1110B Protocol Deviation Unanticipated Problem or Event Log
1111 Specimen Collection and Handling
1111A NorDx Request for NorDx Support of Clinical Research Support
1111B NorDx Laboratory Support for Clinical Research Study (Green Sheet)
1111C Packaging “Biological Specimens, Category B”
1112 Data Management
1113 Audits
1113A Preparing for an Audit Check List
1113B Guidance for Investigators-Regulatory File- Essential Documents
1114 Transportation of Study Documents

Guidance Documents

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.