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

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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 help investigators understand the regulatory requirements for clinical trials registration and results reporting as well as consequences of noncompliance.

Sample of Topics:

• Rules
• Registration
• Record Review Process
• Record Maintenance
• Noncompliance
• 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