As a clinical site staff member participating in the PENS 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 your 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 Responsibilities Log, is available here:

Name File size    
Delegation of Responsibility Log Template 19.48 KB

PENS Required Documents and Trainings 36.41 KB

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

 

The mRS 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 sign the Electronic Signature and Patient Health Information (eSig. & PHI) Agreement before a password will be granted.

# Assigned Responsibility Training Courses Required
1 Take Responsibility for Study Management Human Subjects Certification
Protocol Training Course
EDC Training Course
eCRF/Randomization Training Course
Safety Reporting Training Course
Surgical Training
Shunt Programming Training

2 Coordinator

Human Subjects Certification
Protocol Training Course
EDC Training Course
eCRF/Randomization Training Course
Safety Reporting Training Course

3 Primary Surgeon

Human Subjects Certification
Surgical Training
Shunt Programming Training

4 Backup Surgeon

Human Subjects Certification
Surgical Training Course
Shunt Programming Training Course

5 Blinded Outcomes Assessor

Human Subjects Certification
Gait Velocity Training Course
Montreal Cognitive Assessment Training Course
Symbol Digit Modalities Test Training Course
Beck Depression Inventory Training Course
Lawton ADL Training Course
Modified Ranking Scale Training Course
OAB-q Training Course

6 Obtain Patient Consent Human Subjects Certification
Protocol Training Course
7 Enter Data into the EDC Human Subjects Certification
EDC Training Course
eCRF/Randomization Training Course
8 Maintain Regulatory Documentation Human Subjects Certification
EDC Training Course