As a clinical site staff member participating in the CLEAR-III trial, you must complete a series of training courses designed to ensure patient safety, proper data collection, and compliance with the protocol and regulatory requirements. The list of required courses depends on your specific responsibilities, as delegated to you by the principal investigator. But, before you can access the courses, you must first complete a registration process, which includes responding to an email to verify your identity, and login to this site.
This is an abbreviated and focused version of the protocol information from the Protocol Walk-Thru course. It is intended for residents and nursing staff that will not need access to the online case form and will have only limited responsibilities in this study such as ICU patient management, drug administration, catheter placement or outcome assessments; investigators and coordinators should take the full course. The text-based course is currently under development but in the meantime you can view a set of slides, take a quiz, and generate a certificate of training.
CLEAR-III uses the VISION-EDC system for data collection. Unlike paper-based trials, VISION provides interactive feedback to the coordinator and investigator during the clinical trial. This course is a walk-through of the protocol and case form simultaneously, using a fictitious patient to demonstrate this unique functionality.
This course is primarily intended for the coordinator and investigator that will be working in the oniine case form. There is a shorter course covering just the protocol that is aimed at other members of the site team that have only limited responsibilities in this trial (test article administration, consenting, outcome assessments, etc.)
The CLEAR III Surgical Center based at the University of Chicago provides 24x7 support to site neurosurgeons, neurointensivists and coordinators. Under the direction of Issam Awad, MD, FACS, the Surgical Center provides data-driven, best-practice guidance on optimal catheter placement and surgical case management in this trial. This course discusses the activities of the Surgical Center and gives an in-depth review of the surgical procedures in this study.
This course is for coordinators, investigators and colleagues involved in patient management for the CLEAR-III trial. Starting with a discussion of how the study drug is supplied and prepared, this course then details the randomization procedures and provides details of how the test article is administered and managed in this trial.
This course takes a closer look at the protocol, specifically the scheduling of CT scans and how stability is assessed. It additionally covers the CT-based stopping rules, and the various radiographic measurements. This course is intended for the coordinator who will be recording CT data in the case form, as well as the investigator/surgeon who will be managing the patient's enrollment and test article administration.
Since it's development by Dr. Douglas Graeb in the early 1980's, the GRAEB score, in various modified versions, has been used as a means of quantifying the volume of blood in the ventricles on an IVH patient. For the CLEAR-III clinical trial, a Modified Graeb Score is used as a measure of clot resolution to inform dosing decisions and to assess the stability of the intraventricular hemorrhage. This course, required for investigators, coordinators and anyone making dosing decisions, describes this important IVH volume approximation and how to properly measure it.
Although previous trials have shown that external ventricular drain (EVD) + rt-PA can reduce mortality, it has yet to be determined in a randomized clinical trial whether or not this combination improves neurologic functioning as well. This module will outline the different types of outcome measures acquired in each follow up visit to assess this functioning. The following scales will be covered in detail: Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Mini-Mental State Examination (MMSI), Stroke Impact Scale (SIS), Euro-QOL (5QD), Preference-Based Stroke Index (PBSI), Barthel Index (BI), and Extended Glasgow Outcome Scale (EGOS). In addition, tips and suggestions on conducting follow up assessments will be addressed.
Adverse event reporting is a critically-important responsibility of study coordinators and investigators. This course discusses Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Interest (MEOI's) and explains how they should be documented in the case report forms for the CLEAR III study. Additional topics covered included intensity grading, causality and the functions of the safety team.
This course contains a video detailing the revised drug preparatory procedures caused by the current drug supply situation.