Four (4) lectures given by Mark Barnes, JD:
- Research Compliance: Basic Requirements and Accurate Record Keeping
- Recognizing and Reporting Adverse Events During a Clinical Trial
- What Researchers need to Know about Investigational Drugs and Devices under FDA Regulations (INDs/IDEs)
- The Impact of HIPAA on Clinical Research
Please be patient as the video clips load onto your computer; they must be viewed in Internet Explorer (IE) 6.0+ web browser.
To receive credit, the self-test must be completed and sent to the IRB office at Box 817 (fax: 617-636-8394) or via email IRBoffice@tufts-nemc.org.
Research Compliance: Basic Requirements and Accurate Record Keeping
- Video: General Overview and Record Keeping Requirements
- Post-test Evaluation: General Overview and Record Keeping Requirements. 9/20/02
Recognizing and Reporting Adverse Events During a Clinical Trial
- Video: Recognizing and Reporting Adverse Events During a Clinical Trial
- Post-test Evaluation: Recognizing and Reporting Adverse Events During a Clinical Trial. 10/18/02
What Researchers need to Know about Investigational Drugs and Devices under FDA Regulations (INDs/IDEs)
- Video: Regulatory Requirements for Investigational Drugs and Devices
- Post-test Evaluation: Regulatory Requirements for Investigational Drugs and Devices. 12/6/02
The Impact of HIPAA on Clinical Research - Barnes
- Video: Clinical Trials and HIPAA after August 2002 Privacy Rule
- Post-test Evaluation: Clinical Trials and HIPAA after August 2002 Privacy Rule. 11/8/02
