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MGB HRA Education: Good Clinical Practice (GCP)

Zoom (click website to register/receive link)

Summary: This Good Clinical Practice Webinar course was developed based on the original content of the International Council of Harmonization's Guidance for Good Clinical Practice (GCP) ICH GCP E6R2, current step 4 version dated 9 November 2016. It is intended to provide researchers with training that applies GCP principles to all types of research. GCP […]

MGB HRA Education: Virtual Clinical Research

Zoom (click website to register/receive link)

Summary: This course is for investigators and all members of the study staff conducting clinical research visits virtually. Course content is based on Good Clinical Practice Guidelines, federal and state research regulations, and institutional research policies. Although many research teams require this comprehensive course as part of onboarding, it is also a great refresher for […]

MGB HRA Education: ClinicalTrials.gov Registration & Results Reporting

Zoom (click website to register/receive link)

Summary: The Clinical Trials Registration and Results Reporting course is for investigators responsible for clinical trials.gov registration and results reporting for applicable clinical trials. The course will help investigators understand the Federal and Institutional requirements for clinical trials registration and results reporting. This is a great course to include as a part of onboarding, and […]

MGB HRA Education: Sponsor-Investigator Responsibilities (IND/IDE/NSR)

Zoom (click website to register/receive link)

Summary: This course is for sponsor investigators who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the test article/investigational device is administered, dispensed, or used. Course content is based on the ethical conduct of human research, Good Clinical Practice Guidelines, federal and state regulations, and institutional […]

MGB HRA Education: Clinical Research Bootcamp

Zoom (click website to register/receive link)

Summary: The Clinical Research Boot Camp course is a “clinical research 101” for investigators and all members of the study staff. Course content is based on Good Clinical Practice Guidelines, federal and state research regulations, and institutional research policies. Although many research teams require this comprehensive course as part of onboarding, it is also a […]

MGB HRA Education: Study Team Data Management and Internal Quality Assurance Plans

Zoom (click website to register/receive link)

Summary: This course is for investigators and all members of the study staff. It covers essential information regarding study team data management and internal quality assurance plans. Course content is based on the ethical conduct and oversight of human research, Good Clinical Practice Guidelines, federal and state research regulations, and institutional research policies. Although many […]

MGB HRA Education: Inspections and Audits of Human Subjects Research

Zoom (click website to register/receive link)

Summary: This course is for investigators and all members of the study staff and covers essential information regarding audits and inspections, common findings, how to prepare and how to respond. Course content is based on the ethical conduct and oversight of human research, Good Clinical Practice Guidelines, federal and state research regulations, and institutional research […]

MGB HRA Education: Human Subjects Research Recordkeeping and Record Retention

Zoom (click website to register/receive link)

Summary: This course is for investigators and all members of the study staff. It covers essential information regarding recordkeeping, documentation, and record retention requirements. Course content is based on the ethical conduct of human research, Good Clinical Practice Guidelines, federal and state research regulations, and institutional research policies. Although many research teams require this comprehensive […]

MGB HRA Education: Good Clinical Practice (GCP)

Zoom (click website to register/receive link)

Summary: This Good Clinical Practice Webinar course was developed based on the original content of the International Council of Harmonization's Guidance for Good Clinical Practice (GCP) ICH GCP E6R2, current step 4 version dated 9 November 2016. It is intended to provide researchers with training that applies GCP principles to all types of research. GCP […]

MGB HRA Education: Writing a Clinical Research Protocol

Zoom (click website to register/receive link)

Summary: This course is for investigators and all members of the study staff involved in writing a clinical research protocol. Course content is based on the ethical conduct of human research, Good Clinical Practice Guidelines, federal and state regulations, and institutional research policies. Although many research teams require this comprehensive course as part of onboarding, […]

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