Please refer to the first course on Required Site Training to determine which courses are required by your assigned role in the study.
As a clinical site staff member participating in the MISTIE-III trial, you will need to 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. This is the list of such documents.
Before you can access the courses, you must first complete a registration process, which includes responding to an email to verify your identity, and logging in to this site.
On the 2nd Thursday of months; February, May, August and November we will host online live training sessions for new staff. These training sessions will cover the protocol and also focus on screening and specific tasks related to image acquisition and upload. Everyone is welcome to attend.
The MISTIE III Case Report Form course is a detailed walk-through of the electronic data capture (EDC) online forms used in this study. It is a required course for coordinators and can be used as a reference by other site staff who may occassionally need to use the EDC. As a prerequisite for this course, you should first complete the VISION-EDC Basic Training course and the Protocol Training Course.
This course describes neuroimaging studies in the MISTIE III protocol and the use of CT to guide patient management and dosing decision making. It is a required course for the principal investigator and any subinvestigator that is involved in patient management and dosing decisions.
This course discusses the MISTIE III Surgical Center's role, the steps of surgical review, and the MISTIE III surgical procedure. It is intended for PIs, neurosurgeons (lead and secondary), and for other site staff (coordinators, investigators) involved in patient enrollment and informed consent.
This course covers the study drug for the MISTIE-III trial, how it is supplied and administered, and handled in the Electronic Data Capture (EDC) system. There will be a separate video for drug administration on this website available after the investigator meeting, November 10, 2013, and as a smart phone application, soon to come. It is expected that you will use both the video and the smart phone application as part of your training for support personnel, and that the video be reviewed at the bedside before any new support person administers study drug for the first time.
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 MISTIE III study. Additional topics covered included intensity grading, causality and the functions of the safety team.
This course covers the regulatory and documentation requirements of the MISTIE-III trial. In this course you will learn what documents are needed for the site and individual site personnel. The course also provides study-specific details on how to use the Electronic Trial Master File (eTMF), an important tool for our near paper-less study.
This course discusses the neurological evaluations needed to successfully analyze the cognitive and motor functions of patients enrolled in the MISTIE III trial. It will provide a timeline of when to administer these exams in the MISTIE III trial as well as special considerations for each specific exam and their special characteristics.
This course discusses the modified Rankin Scale (mRS) assessment needed to successfully analyze the cognitive and motor functions of subjects enrolled in the MISTIE III trial. It provides eligibility requirements for the successful MISTIE III follow-up interviews and helpful scripting suggestions, as well as considerations for specific exam components and their characteristics. This training module also includes instruction for digitally recording the interview for remote scoring by the University of Glasgow.
Anyone working with clinical trial participants or having a material involvment in an NIH-sponsored clinical trial must have completed as acceptable Human Subjects course. Here's a list of acceptable courses. Your facility may have its own course instead.
There may be others that are acceptable. Please contact us to discuss your particular course.
This course covers the pharmacy responsibilities for the MISTIE-III trial: a phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage. This training module will provide protocol specific information for the site trial pharmacists and pharmacy staff to manage the study drug inventory, preparation, documentation and other requirements of the protocol. YOU MUST BE LOGGED IN TO VIEW THIS COURSE. REGISTER HERE.