The U.S. launch of MISTIE-III is fast approaching and U.S. sites should be preparing now for the November investigator's meeting (Europe & Asia will launch next year). For the new folks, here's a quick run-down on the several websites you may need to visit. Click the links to go directly to them.
As you know, this is a big trial with lots of groups involved. Hopefully, somebody will create an integrated clinical trial website someday that does all this in one place but in the meanwhile we unfortunately have to deal with multiple sites and differing user accounts.
This is the website you are currently viewing. It is also reachable by going to the coordinating center's website, BrainInjuryOutcomes.com, and selecting MISTIE in the studies menu. This large site is maintained by Emissary and the BIOS coordinating center staff. This is where the project team posts information about the trial, including downloadable documents, calendar events, training resources, and various study resources. There is also an online community for all participating sites and sponsor teams. You must register to access some of the material on this website, expecially the online training courses.
This website (click the link above), maintained by Prelude Dynamics, is the repository of all the regulated study data and study documentation. It has the high security, daily disaster recovery, validation, and audit trails needed to allow its use as an online case report form and electronic trail master file system for a clinical trial. Generally, only sponsor and study site staff that are involved with data collection (i.e., the coordinator), data approval (i.e., the investigator) and regulatory documentation will need to use this site. To obtain access, you must first complete user training (an FDA requirement!) and sign a privacy agreement (a HIPPA requirement). If you already took the courses for CLEAR-III or MISTIE-II, we'll copy your certificates over for you. Don't worry! But, you do still need to sign a new privacy agreement (downloadable below).
|EDC Electronic Signature & Patient Health Information Agreement||107.94 KB|
Modified Rankin certification is provided by a company called Training Campus under contract to the University of Glasgow, who maintains the copyright on this course. As such, there are no alternative vendors, but if you received certification from Training Campus for another study, that will certainly work. Just upload your certificate to the eTMF. The website still says CLEAR-III but this course works for MISTIE-III as well. If you already have a certificate from CLEAR, you do not need to take the course again but be aware that certification does expire.
Other sites you may need: