Emissary College

Knowledge is the key to a successful clinical trial!

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 and login to this site.

The accompanying list shows the assignable responsibilities across the top and the corresponding documentation requirements along the left side. If you are logged in, you may click on the links under your delegated responsibilities (you may have multiple responsibilities) to proceed directly to the corresponding course. You may also print the list for reference (click the icon at the top-right of this page) and then select courses from the menus. Online courses are required for any staff having the corresponding responsibilities even if attending a group site initiation meeting.

After reviewing the course materials and successfully passing the quiz, there will be a button to generate a certificate. Save and email that PDF certificate to your study coordinator for uploading to your personal staff record in the eTMF.

For those who attend a formal site initiation meeting or webinar, you will receive an ADDITIONAL certificate of group training from the coordinating center. These initiation meeting certificates should be uploaded to the eTMF under the group initiation certificate heading (slot 21).  Site initiation meeting attendees are required to take the Basic EDC course prior to the meeting.

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.

 

Documents Required to be Uploaded to the eTMF

DELEGATED RESPONSIBILITIES IN THIS TRIAL

Trial Management
 (Box 1 or 3)

Catheter Placement
(Box 2)

Drug Admin
(Box 2)

Obtain Patient Consent
(Box 4)

Test Article Preparation
(Box 5)

Outcomes Assessment
(Box 6)

Data/Patient Coordination
(Box 8)

Reg. Doc Maintenance
(Box 9)

NIHSS Certification
Slot 5)

Yes + Recertify every 2 years

 

 

 

 

Yes + Recertify every 2 years

 

 

Outcomes Assessment Training
(Slot 6)

Yes or Meeting Certificate

 

 

 

 

Yes or Meeting Certificate

Yes or Meeting Certificate

 

mRS Certification
(Slot 10)

Yes + Recertify every 2 years

 

 

 

 

Yes + Recertify every 2 years

 

 

Protocol Training Certificate
(Slot 11)

Abbreviated Course or Meeting Certificate

Abbreviated Course or Meeting Certificate

Abbreviated Course or Meeting Certificate

Abbreviated Course or Meeting Certificate

 

Abbreviated Course or Meeting Certificate

Full Protocol & EDC Course  or Meeting Certificate

 

CT Training Certificate
(Slot 12)

Yes or Meeting Certificate

Yes or Meeting Certificate

 

 

 

 

Yes or Meeting Certificate

 

GRAEB Certificate
(Slot 12)

Yes or Meeting Certificate

Yes or Meeting Certificate

 

 

 

 

Yes or Meeting Certificate

 

EDC Training Certificate
(Slot 13)

Yes - required for EDC users

 

 

 

 

Only if need EDC access

Yes - required for EDC users

Yes - required for EDC users

eTMF Training Certificate
(Slot 14)

 

 

 

 

 

 

Yes - only available online

Yes - only available online

Human Subjects Certification
(Slot 15)

Yes - any accredited course

 

 

Yes - any accredited course

 

 

Yes - any accredited course

 

Pharmacist Training Certificate
(Slot 16)

 

 

 

 

Yes - webinar with JHU Pharmacist

 

 

 

Surgical Training Certificate
(Slot 17)

Yes or Meeting Certificate

Yes or Meeting Certificate

 

 

 

 

 

 

eSig. & PHI Agreement
(Slot 18)

Yes - Sign & Upload

 

 

 

 

 

Yes - Sign & Upload

Yes - Sign & Upload

Safety Training Certificate
(Slot 20)

Yes or Meeting Certificate

 

 

 

 

 

Yes or Meeting Certificate

 

Test Article Training Certificate
(Slot 23)

Yes or Meeting Certificate

 

Yes or Meeting Certificate

 

 

 

Yes or Meeting Certificate

 

Notes:

Slot numbers refer to the corresponding location in the Electronic Trial Master File (eTMF) where the training certificate should be uploaded. Box numbers refer to the corresponding responsibility checkboxes in the eTMF on a staff member's documents tab. Within the eTMF, checking the various responsibility boxes will present a customized list of upload slots corresponding to the documents in this list that are required for someone having that responsibility. Refer to Emissary's eTMF Training Course for further details.

 

Brain Injury Outcomes

Johns Hopkins University
1550 Orleans Street
CRB-II, 3M50 South
Baltimore, MD 21231 USA
Office:   (410) 614-6996
Fax: (410) 502-7869
 
24-Hr: (410) 736-1368