MGB HRA Education: Writing a Clinical Research Protocol

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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.

Sample of Topics:

• Basic information on clinical research protocols
• Required content for clinical research protocols
• What do to consider after the protocol is finalized
• Resources

Important Notes to Receive Credit:

• Users taking this live (“webinar”) training are required to stay for the entire course duration and complete a knowledge check to receive credit.

— Attendance is tracked through Zoom and cross-referenced with registration in HealthStream. If users do not meet attendance requirements, then they will not receive a Certificate of Completion in HealthStream.

— Re-certification may be required by MGB HRA IRB or the MGB HRA Compliance & Education office.

• This live (“webinar”) training is worth 1 RCR credit-hour toward Part 2 of the MGB RCR Requirements. You will have to stay for the entire training and complete the knowledge check to receive credit, as detailed above. The recorded (“on-demand”) version is not eligible for RCR credit.

Future Dates/Recorded Version:

• The live (“webinar”) version of this training will be offered 2x/year through the MGB Human Research Affairs (HRA) Compliance & Education Office.

— Future dates can be found on HealthStream or on our Brigham calendar.

— Search “MGB HRA” to find all courses.

— Please also see notes above on RCR credit.

• The recorded (“on-demand”) version of this training is continuously available.

— The recorded (“on-demand”) version can be found on HealthStream.

— Search “MGB HRA” to find all courses.

— Please also see notes above on RCR credit.

REGISTER via HealthStream