Investigator Education Pathway – Research Hub

Education Pathway for Investigators

Courses are categorized as Required, Core, and Elective. Click the links below to advance to the relevant trainings or scroll down to view all trainings. Note: If a course is identified as Required, the icons listed below the course tile indicate for what type of research and for whom it is required.

REQUIRED COURSES

HRA Clinical Research Boot Camp

This course is a comprehensive human subjects research training course for investigators and all members of the study staff. The principles established in the content of the course are applicable to all human research investigations.

REQUIRED

HRA Good Clinical Practice

This course provides learners with the international ethical and scientific standard for designing, conducting, recording, and reporting human research trials to assure the protection of subject’s rights, safety and well-being and ensures clinical trial data are credible and verifiable.

REQUIRED

RCO PI Education Series: Research Misconduct Prevention

This course focuses on scientific misconduct requirements for research funded by Public Health Service agencies and identifies PI responsibilities when a research misconduct allegation is made.

REQUIRED

RCO PI Education Series: Financial Stewardship of Grants and Contracts

This course provides an overview of federal, institutional, and sponsor requirements for financial management of grants and contracts to help investigators.

REQUIRED

RCO Controlled Substances in Non-Human Research

This course is for all Massachusetts Controlled Substance Registration (MCSR) and DEA registrants and authorized users of controlled substances working in animal or basic research.

REQUIRED

*MCSR/DEA Registrants and Authorized Users

RCO IBC Required Laboratory Training

The MGB IBC requires all individuals working in a research laboratory as well as study staff listed on a biosafety registration in Insight to complete this training annually to comply with federal regulations.

REQUIRED

*Laboratory and Biosafety staff only

CORE COURSES

HRA Inspections and Audits of Human Subject Research

This course covers essential information regarding audits and inspections, common findings, how to prepare and how to respond to audit findings. The course will teach you to be proactive to ensure your research is being conducted compliantly.

CORE

HRA Informed Consent including eConsent for Human Subject Research

This course provides a comprehensive overview of the informed consent process, including most current research regulations, institutional policies, and best practices for consenting human subjects.

CORE

HRA Study Team Data Management and Internal Quality Assurance Plans

This covers essential information regarding study team data management and internal quality assurance plans. Participants will learn how to develop and implement internal quality assurance plans.

CORE

HRA Sponsor-Investigator Responsibilities (IND/IDE/NSR)

This course is for MGB investigators who hold an IND, IDE, or use a NSR in an investigator-initiated clinical trial. Study staff assisting investigators in the conduct of the clinical trial are also encouraged to attend.

CORE

HRA IRB 101: Collaboration, Partnership, and Research Ethics

This course provides an overview of IRBs and covers the basics of human subjects research and provides important practical information about navigating the IRB process at Mass General Brigham.

CORE

HRA Recordkeeping and Record Retention Requirements

This course provides an overview of how to conduct and document human subjects research in compliance with Good Clinical Practice and the regulatory requirements that govern human subjects research.

CORE

HRA- Virtual Clinical Research

This course is for all members of the study staff conducting clinical research visits virtually and provides guidance in how to conduct these visits in compliance with Good Clinical Practice, Institutional policy and guidance, and regulatory requirements

CORE

RCO Federal Export Control Regulations and Compliance Awareness

This course provides an overview of basic federal Export Controls regulations, recent regulatory changes, and general compliance requirements and identifies research that may have an export component.

CORE

RCO Research Policy Overview: Transporting and Sharing Biological Materials

This course provides a high-level overview of institutional requirements for sharing and transporting research biological materials, including human biological materials.

CORE

RCO Clinical Research Billing Compliance

The Clinical Research Billing Compliance course provides a comprehensive overview of the regulations governing clinical research billing and the processes developed for our researchers to ensure compliance.

CORE

ELECTIVE COURSES

HRA Clinical Trials Registration and Results Reporting

This course will help investigators understand the regulatory requirements for clinical trials registration and results reporting as well as consequences of noncompliance.

ELECTIVE

HRA Writing a Clinical Research Protocol

This course provides an overview of the required content for a clinical research protocol and the protocol-related documents required to conduct research in compliance with regulatory requirements that govern human subjects research.

ELECTIVE

HRA Study Start-up Assessments

This course is for investigators and study staff and covers essential information for what to consider when preparing for your research study to start. Course content is based on the ethical conduct and oversight of human research.

ELECTIVE

HRA Emergency and Non-Emergency Use of Investigational Drugs and Devices for the Treatment of a Single Patient

This course provide guidance to clinicians pertaining to emergency and non-emergency uses of investigational drugs and devices in the setting of treatment of a single patient.

ELECTIVE

RCO General Laboratory Safety

The Mass General Brigham Institutional Biosafety Committee (IBC) requires all individuals working in a research laboratory (i.e., laboratories with chemicals and/or biological agents) as well as study staff listed on a biosafety registration in Insight complete this training annually.

ELECTIVE

RCO Compliance with Section 889, 2019 Federal Defense Authorization Act (FDAA), Covered Technologies

This 45-minute training provides information on the 889 compliance requirements for federal contractors. It addresses the following topics: section 889 prohibitions and effective practices

ELECTIVE

RCO Federal Export Control Regulations and Compliance Requirements

This 90-minute training introduces basic federal Export Controls regulations, recent regulatory changes, and general compliance requirements. Content is hospital-focused and includes case studies that address subjects such as excluded party screening.

ELECTIVE

RCO Federal Export Controls Regulations and Compliance Requirements: International Advisory Services

This 45-minute training focuses on export controls issues that are applicable to negotiating and implementing advisory services agreements with hospitals located outside of the US and its territories.

ELECTIVE

RCO Federal Export Controls Regulations and Compliance Requirements: Sponsored Research, Technology Transfer & Licensing Issues

This training provides knowledge of export control laws, regulations, and compliance as applicable to hospital sponsored research contracting and licensing situations.

ELECTIVE