Education Path 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

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

*RCR Credit Eligible – Live Webinars ONLY!

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

*RCR Credit Eligible – Live Webinars ONLY!

MGBE Research Compliance Education Series for Principal Investigators: Research Misconduct Prevention

This course is focused on scientific misconduct requirements for research funded by Public Health Service agencies – e.g., NIH, FDA
REQUIRED

MGBE Research Compliance Education Series for Principal Investigators: Financial Stewardship of Grants and Contracts

This course provides an overview of federal, institutional, and sponsor requirements for financial management of grants and contracts.
REQUIRED
CORE 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.
CORE

*RCR Credit Eligible – Live Webinars ONLY!

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

*RCR Credit Eligible – Live Webinars ONLY!

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

*RCR Credit Eligible – Live Webinars ONLY!

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

*RCR Credit Eligible – Live Webinars ONLY!

HRA IRB: Using the MGB IRB as the sIRB

This course provides an overview of the use of a Single IRB for review, how to use the Mass General Brigham IRB as the Single IRB for their research studies, and where to obtain more information about Single IRB when needed.
CORE

*RCR Credit Eligible – Live Webinars ONLY!

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

*RCR Credit Eligible – Live Webinars ONLY!

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- Virtual Clinical Research

This course provides guidance in how to conduct virtual clinical research visits in compliance with Good Clinical Practice, Institutional policy and guidance, and the regulatory requirements that govern human subjects research.
CORE

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.
CORE

Mass General Brigham 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, to protect the health, safety and security of staff, the general public, and the intended recipient.
CORE
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