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, […]

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: 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

Zoom (click website to register/receive link)

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

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 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

Zoom (click website to register/receive link)

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)

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. 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)

Zoom (click website to register/receive link)

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 […]