Emissary College

Knowledge is the key to a successful clinical trial!

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.

The list below outlines the courses required based on the responsibilities delegated to you by the Principal Investigator (and so documented in the sites Delegation Log). If you are logged in, you may click on the links  to proceed directly to the corresponding course. A PDF version of this list, along with the blank Delegation of Responsibilies Log, is available here:

Name File size    
Required regulatory & training document Listing 44.46 KB

Delegation of Responsibility Log 45.5 KB

After reviewing the course materials and successfully passing the quiz, there will be a button to generate a certificate. Email the PDF certificate to yourself or your site manager and save it to your computer for uploading to your personal staff record in the eTMF.

 

The mRS, NIHSS, and Human Subjects certifications are hosted by an outside vendor which requires establishing a separate log-in account and password.

Anyone needing EDC access must complete the EDC Training Course and sign the Electronic Signature and Patient Health Information (eSig. & PHI) Agreement before a password will be granted.

# Assigned Responsibility Typically Assigned To: Training Courses Required
1 Overall study management according to FDA-1572 (listed as PI in section 1) PI only

Human Subjects Certification
Initiation Meeting Attendance (or all training courses listed herein except pharmacy)
Protocol Course
EDC Basics Course
Imaging Course
Dosing Course
Regulatory Compliance Course
Safety Reporting Course
Case Form Course
Outcomes Training

2 Listed in FDA-1572 Section 6 (regardless of title). [Select at least 1 other responsibility] Sub-I's Human Subjects Certification
3 Patient identification, screening, scheduling and data/source document collection LEAD Coordinator

Human Subjects Certification
Initiation Meeting Attendance (or all training courses listed herein except pharmacy)
Protocol Course
EDC Basics Course
eTMF Course 
Imaging Course
Regulatory Compliance Course
Safety Reporting Course
Case Form Course

4 OVERSEE the surgical protocol, direct all activies of neurosurgery staff LEAD Neurosurgeon

Human Subjects Certification
Protocol Course
Surgical Training Course

5 Performing an MIS procedure (under supervision of Lead Neurosurgeon) Team neurosurgeons Human Subjects Certification
Protocol Course
Surgical Training Course
6 Obtain Patient Consent PI, SC, Lead NS, Lead NI Human Subjects Certification
Protocol Course
7 Confirm eligibility and AUTHORIZE randomization Usually PI and/or Lead NS Human Subjects Certification
Protocol Course
Imaging Course
NIHSS Certification
mRS Certification
8 OVERSEE in-hospital patient management and direct/manage all dosing procedures LEAD Neurointensivist Human Subjects Certification
Protocol Course
Imaging Course
Dosing Course
9 Administer dose Lead & Team neurosurgeons and/or Lead/Team neurointensivists Human Subjects Certification
Dosing Course
10 ASSESS CAUSALITY of adverse events Usually PI only Human Subjects Certification
Safety Reporting Course
11 Perform the NIHSS assessment (baseline, screening, outcome visits) Usually neurointensivists (baseline) and blinded outcomes assessor Human Subjects Certification
NIHSS Certification
12 Perform the mRS assessment (historic) and video interview (outcome visits) Usually coordinator (historic) and blinded outcomes assessor Human Subjects Certification
mRS Certification
13 Conduct the Outcomes Assessment Interview Blinded Outcomes Assessor only Human Subjects Certification
Outcomes Training
14 Enter/Edit data, upload source documents & imaging, randomize patients in the EDC PI, Sub-I, Coordinator

Human Subjects Certification
Case Form Course
EDC Training

15 Compile and maintain regulatory documentation in the eTMF Lead coordinator, documentation specialist

EDC Basics Course 
eTMF Basics Course
Regulatory Compliance Course

16 OVERSEE the secure storage, sterile preparation and dispensing of study drug Lead Pharmacist, study pharmacists Pharmacist Training

 

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