Monthly Webinar Series

August 2019

Today’s Agenda

Announcements & Trial Updates Sandi Cassard

Monthly Randomization Race Amanda Bistran-Hall

Recently Asked Questions Sandi Cassard

Q&A All

Announcements & Trial UpdatesSANDI CASSARD

Study Updates – EnrollmentTHANK YOU to activated sites for continuing to screen and enroll patients!

We have 46 sites activated and 258 patients enrolled as of 08/06/19!

We enrolled 24 patients across all sites in July, and need to do much better in August! Remember the commitment you made to this trial and get all hands on deck NOW!

Please find at least 1 new candidate each week so we can accelerate enrollment!!!

Study Updates - Reminders1) VISION is generating emails to study coordinators each Monday to open the database and look for open queries.

2) Responding to queries in a timely manner helps your site and team in the rowboat challenge!

3) Please save and submit for review any page where you have entered data, made a change or responded to a query. Each page that appears “blue” must be submitted for review so the test tube turns “orange” in order for the page to be monitored.

4) All pages for a visit must be submitted for review to receive payment for the visit!

THANK YOU for submitting data and uploading source documents promptly!

Study Updates – CRF changesREMINDER from JULY 2019 Webinar:

Please visit the study website: http://treat-mstrial.org to download recently updated case report forms (CRFs). The latest updates have V2.2 in the file name and impact the study-long AE, SAE, Concomitant Medications and Protocol Deviations forms as well as Interim Visit, Month 6 follow-up and Month 12 follow-up forms. PLEASE DISCARD OUTDATED CRFs and BEGIN USING THE LATEST CRFs found on the study website.

Study Updates – Biobanking SubstudyCurrent contracting efforts are focused on the BIOBANKING SUBSTUDY funded by the National MS Society. A draft of this new subcontract has been sent to participating sites and retroactive payments will be made for all samples drawn and processed/shipped since 2018 as soon as the subcontract is executed. THANK YOU for continuing to enroll and draw samples for the biobanking substudy!

Please reach out to Susan Emrich, Biobanking Manager, with any questions semrich1@jhmi.edu.

Study Updates – Save the DateNext in-person SAC Meeting

Wednesday, February 26, 2020

1:30 – 5:00 pm EST

Hilton West Palm Beach, Florida

(preceding ACTRIMS meeting)

Monthly Randomization RaceAMANDA BISTRAN-HALL

Monthly Randomization RaceJuly’s Top Performers:

Site Randomizations

Johns Hopkins Hospital 4

Baylor Research Institute 3

Geisinger Clinic 3

Rush University Medical Center 2

July’s Top Enroller:

Geisinger Clinic

$50

August 2019 WebinarMADIHA QUTAB, MSPROJECT MANAGERTREAT-MS TRIALJOHNS HOPKINS UNIVERSITY

SANDRA CASSARD, SCDPROJECT DIRECTORTREAT-MS TRIALJOHNS HOPKINS UNIVERSITY

Recently Asked Questions (RAQs) and AnswersTopics

1) Onboarding new study team members◦ How do they get access to…?

2) Scheduling logistics for MRIs

3) DMT changes and AE reporting

4) Registering screen failures in EDC

5) Resources ◦ Where can I find…?

1) Onboarding new study team membersQuestion: How does a new study team member access the training materials for TREAT-MS?

Answer: Training materials are found on the TREAT-MS trial’s website.

To register for the TREAT-MS website:

1) Please go to http://treat-mstrial.org/

2) Click on “Register for an account”.

3) Go to the 3rd profile type “TREAT-MS” and register. You can skip the TwoStep Verification. Once registered, you should have access immediately. You can log in using your user name or your email.

Training on TREAT-MS trial website

1) Onboarding new study team membersTraining needs:

Good Clinical Practice (GCP) – ALL study team members

Protocol – ALL study team members

EDC Basics – Unblinded Coordinators, regulatory specialists

MSFC, LCVA, SDMT Videos / Attestation – blinded MSFC examiners

EDSS experience (neurostatus certificate from prior trial or Note to File from PI that EDSS examiner has experience as EDSS examiner from a prior/concurrent trial) – blinded EDSS examiners

Example GCP course

Protocol and EDC training on TREAT-MS trial website (http://treat-mstrial.org/)

MSFC, LCVA, SDMT Training Videos / Attestation

1) Onboarding new study team membersQuestion: How do we add a new study team member to VISION?

Answer: Log in to VISION, click on the SITE list, select your site. Go to the Documents tab. Click on any study team member already listed. At the bottom of the page, click on “Add new personnel” tab. Check off roles corresponding to the Delegation of Responsibility (DOR) Log. Upload certificates and updated DOR log and request a VISION account if person is NOT serving as a blinded examiner.

A blank DOR log is available on the TREAT-MS website documents section.

VISION – Site List

Adding Personnel to VISION

Delegation of Responsibility (DOR) Log

2) Scheduling logistics for MRIsQuestion: What is the window for getting the Month 6 MRI completed?

Answer: The Month 6 MRI should be completed after the patient has been on his/her 1st DMT for AT LEAST 6 months. For setting up your visit tracker and optimal timing of the Month 6 MRI, see below example:

Example 1: DMT started within 2 months of randomization

Randomization date: 02/15/19

DMT start date: 03/25/19

Month 6 MRI: after 09/25/19, assuming patient has remained on the same DMT for 6 months

Month 6 MRI if you suspect new activity and want to use it as evidence of breakthrough disease: after 10/25/19.

2) Scheduling logistics for MRIsQuestion: What is the window for getting the Month 6 MRI completed?

Answer: The Month 6 MRI should be completed after the patient has been on his/her 1st DMT for AT LEAST 6 months. For setting up your visit tracker and optimal timing of the Month 6 MRI, see below example:

Example 2: Delay in start date for DMT

Randomization date: 02/15/19

DMT start date: 5/12/19

Month 6 MRI: after 11/12/19, assuming patient has remained on the same DMT for 6 months

Month 6 MRI if you suspect new activity and want to use it as evidence of breakthrough disease: after 12/12/19. You may still label and upload this as a Month 6 MRI, even if it falls within the early part of the Month 12 MRI visit window.

3) DMT changes / AE reportingQuestion: If a patient has side effects from the 1st DMT and the dose is modified twice before discontinuing it within 2 months of starting it, how should that be reflected in VISION?

Answer: Each dose modification/discontinuation should be reflected on the DMT page. Each distinct side effect leading to a dose reduction or discontinuation should be reflected on the Adverse Events (AE) page.

Please provide a separate entry on the DMT page for each new dose, including start and end dates for each dose.

Please create an AE for each distinct side effect leading to a dose change / discontinuation. Please update the dates and outcome of the AE(s) once resolved (if applicable).

AE reporting examples:If Medical-Event Term not specific to AE being reported, enter in as “Other” and specify.

Medical-Event Term for unexpected pregnancy: Unintended pregnancy

Early DMT switches – MRI timingQuestion: Our patient took her 1st DMT for 2 months, then discontinued due to side effects. She is starting her next DMT within the same treatment class within a month of discontinuing the 1st medication. When should we obtain her next MRI?

Answer: This patient can be re-baselined (new MRI obtained following CMSC guidelines, if clinically indicated, as determined by treating clinician) prior to starting the 2nd

DMT, and then the month 6 MRI will be after the patient has been on this 2nd DMT for at least 6 months.

4) Registering screen failures in visionQuestion: How do I register a potential candidate in vision who refused to participate after discussing TREAT-MS with a provider?

Answer: If the provider discussed (in a meaningful way) the TREAT-MS study with a potential candidate or gave them a consent form to review, candidate should be registered in vision as a new patient, similar to how a patient is registered when they are consenting to the study (complete demographics page). All registered patients will be assigned a patient ID. Complete the study entry page as fully as possible. If patient refuses to participate prior to consent, update study entry exclusion criteria, and save the data entry page (age will not calculate if consent date is not completed, which is fine).

No need to submit the page for review.

Patient Status

5) ResourcesQuestion: How do I create a patient login in vision for patient to complete ePROs?

Answer: Patient ePRO login demonstration video is available on the TREAT-MS website under the Documents section.

Question: How do I label the MRI DICOM before I upload to vision?

Answer: MRI manual is available on the TREAT-MS website which speaks to the MRI upload requirements.

Open for Questions

Thank You for attending today’s webinar!

The September Monthly Webinar will be held on the

4th at 3 PM and 5th at 9 AM EDT