ARCADIA CSI (Cognition and Silent Infarcts) "Study"

Project: Research project

Project Details

Description

EACH CLINICAL TRIAL PERFORMANCE SITE WILL BE RESPONSIBLE FOR: 1) Complying with the study investigational plan as defined in the protocol and approved by the StrokeNet CIRB and the NINDS appointed DSMB
2) Compliance with study specific StrokeNet CIRB informed consent template
3) Obtaining appropriate Central IRB and local IRB acknowledgement of CIRB review
4) Reporting of required adverse events to CIRB and to the WebDCU CTMS for central trial review in compliance with defined procedures
5) Completion of internal logistics necessary to execute the study
6) Completion of Clinical Trial Agreement
7) Documentation of qualified clinical and protocol trained site personnel
8) Documentation of qualified human subject protection trained site personnel
9) Documenting study related financial conflict of interest for all site personnel
10) Assurance that standard medical care and management of adverse events will be provided for all subjects randomized
11) Complying with all local, and US federal requirements for the initiation and ongoing performance of a clinical study 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”
12) Assuring that the expenses for research related procedures are not billed to the subject
13) Assurance of access to subject medical records for site monitoring visits per institutional and study procedures.
14) Providing a site representative to attend all required investigator meetings and study conference calls
15) Entering screen failure data in WebDCU™ within 5 days of screening
16) Data collection entered into WebDCU in a time frame consistent with the MOP
17) Compliance with all ARCADIA-CSI policies and procedures published in the study MOP. MOP will be available under Project Documents in the WebDCU™ CTMS and some sections may be posted on the StrokeNet website: http://www.nihstrokenet.org/
18) Responsiveness of site PI or in his/her absence, another designated investigative team member, to email correspondence within 2 business days
StatusActive
Effective start/end date7/1/196/30/24

Funding

  • University of Cincinnati (012340-133385//1U01NS110728-01)
  • National Institute of Neurological Disorders and Stroke (012340-133385//1U01NS110728-01)

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