EACH CLINICAL TRIAL PERFORMANCE SITE WILL BE RESPONSIBLE FOR: • Complying with the trial investigational plan as defined in the protocol and approved by the StrokeNet CIRB, NINDS appointed DSMB and FDA • Obtaining CIRB approval for the performance site and reporting of adverse events • Completion of necessary Internal logistics necessary to execute the trial (including RAPID instillation software) • Documenting appropriately qualified and protocol trained site personnel • Treatment of subjects according to their treatment assignment into intervention or control groups and assurance that standard medical care and management of adverse events will be provided • Complying with all local, state, and US federal requirements for the initiation and ongoing performance of a clinical trial per the principles of Good Clinical Practice as defined in ICH Consolidated Guidance (ICH E6) and Title 45 and part 46 Federal Policy for the Protections of Human Subjects “Common Rule” • Assuring that the expenses for research related procedures are not billed to the subject • Assurance of access to subject medical records for site monitoring visits per institutional and trial procedures. • Providing a site representative to attend all required investigator meetings and trial conference calls • Completion of screen failure logs by the 10th of the month in the WebDCU™ system • Subject data collection entered into WebDCU database within a time frame determined by the WebDCU or 10 business days whichever is greater. • Providing digital uploads of all protocol required images (angiogram if done, and all brain scans through discharge) within 5 working days of subject discharge • Compliance with all DEFUSE 3 policies and procedures published in the trial MOP. MOP will be available under Project Documents in the WebDCU™ CTMS as maintained by the NDMC.
|Effective start/end date||9/30/15 → 8/31/18|
- University of Cincinnati (010085-110021//1U01NS092076-01A1 R)
- National Institute of Neurological Disorders and Stroke (010085-110021//1U01NS092076-01A1 R)
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