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 […]

REDCap: Getting Started

Zoom (click website to register/receive link)

Summary: In collaboration with the Harvard Catalyst, REDCap is a free, secure, web-based application hosted by MGB Research Computing and designed to support electronic data capture for research studies. To learn more about REDCap visit: http://rc.partners.org/edcredcap. This course will provide a high level overview of the REDCap tool. Learn about study start up, project life cycles, data […]

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 […]

REDCap: eConsent Functionality

Zoom (click website to register/receive link)

Mass General Brigham (MGB) has developed a REDCap eConsent Framework that will turn the paper-based informed consenting processes into an electronic informed consent process that researchers can use for Institutional Review Board (IRB) reviewed and approved studies. The MGB REDCap eConsent Framework will allow users to implement a combination of the validated components to design […]

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.   […]

REDCap: Clinical Data Pull (CDP) Functionality

Zoom (click website to register/receive link)

REDCap can communicate with any EHR (electronic health record system) that has implemented 'SMART on FHIR' web services that allow for interoperability and limited data extraction from the EHR. In this way, REDCap can be embedded inside and launched within EPIC. This allows REDCap users to easily add patients to their projects and/or to access […]

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 […]