MGB HRA Education: Good Clinical Practice (GCP)

Zoom (click website to register/receive link)

CLICK HERE TO REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) International Council of Harmonization (ICH) Good Clinical Practice (GCP) course complies with the expectations set by the NIH National Center for Advancing Translational Sciences for GCP training and meets the minimum criteria for ICH GCP E6 R1 and R2. The course […]

MGB HRA Education: Inspections and Audits of Human Subjects Research

Zoom (click website to register/receive link)

REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) 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 […]

MGB HRA Education: Clinical Research Bootcamp

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CLICK HERE TO REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is a comprehensive human subjects research training course for investigators and all members of the study staff. Course content is based on the ethical principles of human research protections, Good Clinical Practice (GCP) Guidelines, federal and state research regulations, institutional […]

MGB HRA Education: ClinicalTrials.gov (CT.gov) Registration & Results Reporting

Zoom (click website to register/receive link)

REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is strongly recommended for investigators responsible for ClinicalTrials.gov registration and results reporting for applicable clinical trials. This course is also recommended for members of the study staff assisting the investigator with entering information in records, maintaining records, and reporting results. The course will […]

MGB HRA Education: Recordkeeping and Record Retention Requirements

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CLICK HERE TO REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is for investigators and all members of the study staff and covers essential information regarding recordkeeping, documentation, and record retention requirements. Course content is based on the ethical conduct of human research, Good Clinical Practice (GCP) Guidelines, federal and state […]

MGB HRA Education: Writing a Clinical Research Protocol

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REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is intended 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 (GCP) Guidelines, federal and state regulations, and institutional research policies.   […]

MGB HRA Education: Informed Consent of Research Subjects (Including eConsent)

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CLICK HERE TO REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is for investigators and all members of the study staff. Course content is based on Good Clinical Practice (GCP), federal and state research regulations, and institutional research policies. Although many research teams require this comprehensive informed consent course as part […]

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

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CLICK HERE TO REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is for MGB investigators who hold an IND, IDE, or use a NSR in an investigator-initiated clinical trial. Study staff assisting sponsor-investigators in the conduct of the clinical trial are also encouraged to attend. Course content is based on the […]

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

Zoom (click website to register/receive link)

CLICK HERE TO REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is for investigators and all members of the study staff and 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 (GCP) […]

MGB HRA Education: Virtual Clinical Research

Zoom (click website to register/receive link)

CLICK HERE TO REGISTER via HealthStream   Summary: This MGB Human Research Affairs (HRA) course is for investigators and all members of the study staff conducting clinical research visits virtually. Course content is based on Good Clinical Practice (GCP) Guidelines, federal and state research regulations, and institutional research policies. Although many research teams require this […]