Education Pathway for Research Staff
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.
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.
REQUIRED
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
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
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
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
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
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
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
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 that govern human subjects research.
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, to protect the health, safety and security of staff.
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 to assist researchers.
CORE
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory
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
- Investigators
- Research Staff
- Research Trainees
- Humans
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
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
- Investigators
- Research Staff
- Research Trainees
- Humans
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
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory
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
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory
- Investigators
- Research Staff
- Research Trainees
- Humans
- Animals
- Laboratory