The PI and the study team at Northwestern University are expected to conduct the following activities: 1. Conduct the study in accordance with the Protocol. 2. Follow the ICH guidelines of Good Clinical Practice and state and local laws, regulations and guidelines relative to the conduct of a study involving human subjects. 3. Obtain IRB approval for conducting the study according to local requirements before any subjects are enrolled. 4. Provide the Coordinating Center with copy of the initial IRB letter of approval and the annual study renewal. 5. Ensure that each patient enrolled, or the legally authorized representative, shall give his/her written informed consent before performing any study-related activity or assessment. 6. Ensure that only the currently IRB approved Informed Consent Form is used to obtain authorization to participate in the study. 7. Facilitate and participate in the study-specific trainings provided by the study. 8. Actively screen for participants. 9. Complete the Clinical Research Forms in a timely manner. 10. Enter data in the study Electronic Data Capture system in a timely manner. 11. Respond and resolve queries appropriately. 12. Inform Coordinating Center and PI of serious adverse events and follow local IRB adverse event reporting policy. 13. Maintain all regulatory documents up to date.
|Effective start/end date||3/1/16 → 2/28/21|
- University of Miami (SPC-000248//5R01NS084288-05 REVISED)
- National Institute of Neurological Disorders and Stroke (SPC-000248//5R01NS084288-05 REVISED)
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