Program Overview

The certification program involves up to five stand-alone web sessions lead by a Viedoc Product Specialist and two homework assignments. The training is intended for users who are working with designing and building studies in Viedoc, i.e. study setups.

To get the most out of the training and to allow time for the homework assignments, it is recommended that there are 3-5 days between session #1-3.

The below table lays out the high level content of the training. For a more detailed information about each session see the detailed agenda for each session by clicking the link:

Session	Duration	Content	Assignment
Prerequisite*	60 min	Introducing Viedoc Clinic from the perspective of different user roles.	Hands-on training
# 1	90 min	Introducing Viedoc Admin and Designer. Building first small study focusing on forms and workflow.	Homework #1 (Needs to be completed before start of session #2)
# 2	90 min	Change management. Updating your study.	Homework #2 (Needs to be completed before start of session #3)
# 3	90 min	Study maintenance and close-out.
Follow-up	60 min	Open Q/A

* Only applicable if you are new to Viedoc

Prerequisite Session

Duration: 60 minutes

This session is required if you are unfamiliar with Viedoc. The following sections of Viedoc are covered during the prerequisite session:

• Introduction to Viedoc Clinic as
  • Investigator
    • Add new patient
    • Scheduled/unscheduled events
    • Add new event
    • Deleting / resetting data
    • Answering queries
    • Confirm data as missing
    • Signing
    • ViedocMe*
  • Monitor
    • SDV review
    • CRA review
    • Raise / approve queries
  • Data Manager
    • Locking forms
    • Data review
    • Exports
  • Site Manager*
    • User management
    • Resetting passwords
  • Medical Coder*
  • Reference Data Entry*

*optional

After the session is completed you will get access to a demo study in Viedoc with several different user roles.

Session #1

Click here for agenda.

Session #2

Click here for agenda.

Session #3

Click here for agenda.

Follow-up session

Duration: 60 minutes

The follow-up session is planned approximately a month after the third session is done or after/during the setup of the first study. This a a pure Q/A session and not part of the certification.

Agenda

Duration: 90 minutes

The first session of the certification program presents Viedoc Admin and Designer and introduces step by step how to initiate and build a study in Viedoc.

• Overview of Viedoc Admin
  • Studies
  • Users
  • System roles (study manager, designer, ...)
  • eLearning
• Add new study
  • Study settings
  • Study crew
  • Study design
  • Add sites
• Overview of Viedoc Designer
  • Setting general info (design settings)
  • Global templates: forms and groups
• Element types / creating a form
  • Create Demographic form
  • Create Vital Signs form
• Simple edit checks and visibility conditions
• Study Workflow
  • Events and Activities
  • Recurring events
  • Repeating forms
  • Unscheduled events
  • Common events
  • Programming visibility conditions
  • Setting visit windows
• Roles
  • Limit view/edit permissions of certain roles
• Study Settings
  • Designing card
  • Setting SubjectKey
  • SDV requirements
  • Setting alerts
  • Setting subject status (metrics)
• Outputs/publishing study
  • Configuration Report
  • Annotated CRF
  • Study Workflow printout
• Assigning design in Viedoc Admin
  • Managing sites
• Homework Assignment #1

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eLearning references

• Viedoc Admin (extracts from Viedoc Admin User Guide):
  • Overview of Viedoc Admin
  • Adding a new study
  • Managing users
  • Setting up user documentation and training
  • Managing study sites
• Viedoc Designer (extracts from Viedoc Designer User Guide):
  • Initiating a design
  • Overview of study design
  • Creating and editing forms
  • Study workflow
  • Configuring roles
  • Study Settings:
    • Selection View Settings
    • Subject ID Generation Settings
    • SDV Settings
    • Setting up Alerts
    • Setting Subject Status (for study metrics)
• Viedoc Admin - Assigning a study design

Assignment #1

Summary: Create a simple study, invite yourself as an investigator, and enter data for a new patient to verify the setup is working as expected.

Follow the steps below to complete the assignment:

1. Open Viedoc Admin, click Add a new study.
2. Add info regarding the study.
   • Name your study as your first name in the Study name field.
   • Enter your email address in the Study Manager field.
3. Click Add study.
4. In the Study crew section, click Edit to open the study crew page.
5. Click Add study users, enter your email address in the text field, click Continue.
6. Choose Designer as role in the drop down menu, click Send invite.
7. Open Viedoc Designer.
8. The study will appear in the projects window in Designer. Click on the study with your name under Projects.
9. For a new design version you have two options; choose Add new empty design version
10. Fill out Internal Description, Study Name, Study Description(optional), Protocol Name and Version and click Save study settings.
11. You will end up at the Design Overview page. Should you need to edit any study information, click Design Settings.
12. In the Forms section, click Edit and create the following form by clicking Add a new form:
    • Demographics (ID = DM), with following variables:
      • Date of Informed Consent
      • Sex
      • Date of birth
      • Age (derived), use eLearning to find how to calculate age.

13. Create another form:
    • Vital signs (ID=VS), with following variables:
      • Were vital signs performed?
      • Date and time
      • Systolic BP
      • Diastolic BP
        • Add a data check that prevents the form from saving if VSSYS<VSDIA.
      • Temperature (allowing one decimal).
        • Add a data check to control for values between 36.5 and 38.

Don't forget also to add relevant visibility conditions.

14. Create another form:

• Adverse Event (ID = AE) with the following variables:
  • Sequence number
    • Use eLearning to learn how to add a counter for the sequence number. Hint!StudyEventRepeatKey
  • Description
  • Start date
    • Add an edit check to control for dates before informed consent Hint!EventID.FormID.ItemID
  • Ongoing?
  • End date date
    • Add an edit check for end date to occur after start date
  • SAE?

Remember to also add all relevant visibility conditions.

15. Go to Study workflow, click Edit.

• Start by adding the start event by clicking Study Start and Add study event

• Complete the pop-up with info on Study event ID and Event name

• Add an activity to the event by clicking the green plus icon and set an Activity ID

• Add a form to the activity by clicking the yellow plus icon and choose the Demographics form in the drop down menu. The screen will now look like the image to the right.

• Click on Scheduled Events and add a screening visit with ID "E01_SCR" and name "Screening". Add an activity the same way as for the screening event.
  • Add the vital signs form to the activity but prevent the temperature item from appearing at specifically this visit. Hint! Customize Item Visibility.
• Go to Common Events
  • Add an event for the Adverse Events and which includes the AE form
  • Set the summary format as {AE.AENO} - {AE.AEDESC} - {AE.AESTDAT}

• Go back to Scheduled Events Add a second Event, "Follow-up" with ID “FUP”)
  • Add pre- and post-dose activities and include the vital signs form in both activities
  • Set the vital signs form in the post-dose activity to repeat 3 times
  • Set the visit to repeat a total of 3 times
  • Set the Short Summary Format as “Follow Up V{StudyEventRepeatKey}”
  • Set the visit schedule so that all visits, starting with the Screening visit are 1 week apart from each other.
  • Set all visits to have a +/- 3 day window
• Go to Roles:
  • Enable the Investigator role
  • Enable the Monitor role
• Go to Study settings:
  • Selection view settings
    • Map the sex variable to the avatars and the next variable to the Age item
  • Patient ID settings
    • Create a patient ID with a prefix "SCR" followed by the site ID and a four-digit patient sequence number {CountryCode}-{SiteCode}-{SiteSubjectSeqNo}.
• Go back to the Designer start page and click Validate and correct any errors.
• Click Publish design.

In Viedoc Admin:

• Click on Add a site to this study
• Click Study Design, assign the design on 01 JAN 2019
• Go to Study crew, invite yourself as an investigator and create a new patient in Viedoc Clinic
• If you need to make corrections, create a new, fully-customizable version.
  • Publish again on the same date as before: 01 JAN 2019

Extra credit (optional)

In Viedoc Designer go to the latest effective design, create a new, fully-customizable version.

• Study settings / Alerts
  • Add an alert titled “New Patient”
    • Have the alert send when the informed consent variable has data and the form is saved
    • Send an email to the investigator and monitor roles
    • In the body of the message, include the SubjectKey of the added patient
  • Add activity-dependent labeling within a form.
    • On the VS form, add a static text item with the following text, “Vital Signs post dose must be collected 3 times.”
    • Make this text large, green, and bold.
    • Program a visibility condition for this item so that it only appears on the post-dose activity.
  • Create a Lab form (for use with reference data feature)
    • In a separate group at the top of the form, add a field for collection date
    • For a single lab parameter, create a group with the following items:
      • Dropdown list (labeled “prefix”) with following options:
        • “=” (should be default selection)
        • “<”
        • “>”
      • Number field for the result and allow for 6 decimals
      • Dropdown list for the unit
      • Range field allowing for 6 decimals
      • A Yes/No response for “Clinically Significant” with the following advanced visibility condition:
        • !inRange(RANGEID, RESULTID)
• ViedocMe (ePRO) (see instructions related to "subject initiated events" in this lesson - https://help.viedoc.net/c/e311e6/2eae19/en/)
  • Create a form labeled “Dosing Diary” with ID “DD” and containing a Visual Analog Scale item with ID “DDVAS”
  • In study Workflow, create an event that is “Subject Initiated” (instructions in section 2.4 of the above mentioned lesson)
  • Set the Short Summary Format as “Diary Day {StudyEventRepeatKey}”
  • Set the visit so that it occurs for 28 days straight, and beginning on the screening visit
  • Create two activities for morning and evening assessments, and add the Dosing Diary form to each activity
  • For each Activity, create a 12-hour window for each assessment.
    • The morning assessment should start at midnight and end at noon.
    • The evening assessment should start at noon and end at midnight
  • Add two reminders for each assessment:
    • For each reminder, include the link that the patient should connect to in the message body.
    • Reminder 1, morning assessment should send at 09:00
    • Reminder 2, morning assessment should send at 10:00
    • Reminder 1, evening assessment should send at 21:00
    • Reminder 2, evening assessment should send at 22:00

Agenda

Duration: 90 minutes

The second session focuses on updates to a design version via a version or revision.

• Q/A from homework #1
• Cross-form functions, visibility conditions, and edit checks.
• Global design settings vs. Design version.
• Version management
  • New version
  • Revision
• Export/Import study designs
• Homework Assignment #2

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eLearning references

• Cross-form functions, visibility conditions, and edit checks. eLearning references:
  • Using JavaScript in Viedoc
  • Adding an auto counter in common events
  • Calculating the age of a subject
  • Using advanced visibility conditions
  • Controlling the format of a date/time variable
  • Configuring a check to apply to a specific event or activity
  • Checking if date only is entered for a Date and Time variable
• Global design settings:
  • Designer settings
  • Configuring medical coding scopes (Optional, only if Medical Coding is used in the study)
  • Creating a data mapping for import of data (Optional, only if Data Import is used in the study)
  • Configuring reference data scopes (Optional, only if Reference Data is used in the study)
• Version management:
  • Viedoc study configuration management
  • Duplicating a design - versions and revisions
• Export/Import study designs:
  • Exporting/Locking/Deleting a study design
  • Importing a new design version

Assignment #2

Before beginning this assignment, make sure you have at least one patient entered from the previous assignment.

In this assignment, you will update your existing study with additional forms and conditions. Follow the steps below to complete the assignment.

Start by duplicating your design as a Revised version.

Go to Forms.

• Add new form: Pregnancy Test (ID = PT)
  • Add a radio button for the result (positive / negative)
  • Add a date field (PTDAT) with the following edit check:

var a = E00_START.DM.DMICDAT;

if ( !a || !PTDAT)

return true;

else return (PTDAT >= date(a));

• Add new form: Electrocardiogram (ID = ECG)
  • Add numeric fields with edit checks for the following variables:
    • PR interval (ms)
      • Should be between 120 and 200 ms
    • QRS interval (ms)
      • Should be between 80 and 120 ms
    • QT interval (ms)
      • Should be below 450 ms for male patients, and below 480 ms for female patients
• Add new form: Unscheduled assessments (ID = UN)
  • Add a check box item (ID = UNTESTS) asking which procedures were performed. Include the following choices:
    • Vital Signs (code = 1)
    • ECG (code = 2)

• Go to Study Workflow
  • Add the ECG and Pregnancy test forms to the screening visit. Program a visibility condition such that the Pregnancy test only appears for female participants. The Electrocardiogram should appear for all patients.
  • Create an unscheduled visit
    • Create three activities:
      • Activity with UN form
      • Activity with Vital signs form
        • Program the following visibility condition: $THIS.UN.UNTESTS.contains(1)
      • Activity with ECG form
        • Program the following visibility condition: $THIS.UN.UNTESTS.contains(2)
• Publish the study, assign the revised version in Admin and create a new female subject in Clinic
  • Complete the ECG form and enter a value of 460 ms
  • Change the sex of the patient from female to male and verify that a cross-form edit check fires on the ECG form.

Extra credit (optional)

• Add a hidden form
  • Create a new form with a free text field labeled “study status”
    • Have this item return the following function:

if(E00_START.DM.DMICDAT!=null)

return “Enrolled”;

else return “Screened”;

• • Under the forms Advanced settings (find this by clicking the form label) select “Auto update functions” as well as “Hidden form”
  • Add this form to the starting event, within the same activity as the Demographics form.
  • Under Study Settings / Selection View Settings, use this item to display the subject’s current status in the card view

• Add translations to ViedocMe forms (requires new version)
  • Under Design Settings / Details, add an additional language and save changes.
  • A Language Import/Export tab will appear under Design Settings
    • Select the language you wish to translate and then pick the forms you wish to translate – export the forms. An Excel document will download.
    • Open the Excel and file and perform the translation in column D.
    • Once finished, upload the document and save changes.
    • Publish and assign the design.
    • Verify the updates by adding a new subject and initiate the ViedocMe account in Clinic. The additional language should now be available in the drop down list in the ViedocMe account window.

Agenda

Duration: 90 minutes

The third session focuses on study maintenence issues.

• Q/A from homework #2
• Handling license keys (section 3.5 in lesson https://help.viedoc.net/c/331b7a/3601dc/en/)
• Locking Study (https://help.viedoc.net/c/331b7a/d828b8/en/)
• 1 or 2 optional topics of your choice from the following:
  • Medical Coding
  • Reference data
  • Randomization
  • ViedocMe and Translations
• Support
• Roadmap
• Continuing education / how to stay in touch

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eLearning references

• Licensing - section 3.5 in this lesson - https://help.viedoc.net/c/331b7a/3601dc/en/
• Locking and deleting a study:
  1. Locking a study (for Study Managers)
  2. Deleting a study (for Study Managers)
  3. Deleting a study (for Organization Admins)
• Medical coding:
  1. Viedoc Designer - Configuring medical coding scopes
  2. Viedoc Admin - Managing medical coding dictionaries
  3. Viedoc Clinic - Medical coding
• Reference data:
  1. Viedoc Designer - Configuring reference data scopes
  2. Viedoc Admin - Managing reference data sources
  3. Viedoc Clinic - Working with reference data
  4. A use case for working with reference data
  5. Video tutorial
• Randomization:
  1. Viedoc Designer - Setting up the randomization
  2. Viedoc Admin:
     • Configuring a static randomization
     • Configuring a dynamic randomization
  3. Viedoc Clinic - Randomization, allocation and emergency unblinding
  4. A use case for dynamic randomization
  5. Video tutorial

Support

As a certified designer you will be able to contact the Viedoc Product Specialist team for support through support@viedoc.com. The support is available during office hours (CET) and will respond to your questions within maximum one working day or as soon as possible. Your organization will be responsible for supporting your end users, such as site staff and monitors. All questions directed to our support team should go through the certified designers in your organization.

Extra session free of charge

A follow-up Q&A session is included in this training program. Please feel free to contact the Product Specialist that was assigned to your training within 6 months after the certification is completed. We recommend that this session is held when you have started working actively in Viedoc designer and have done some work on your first study.

Watch out for new releases!

Stay updated. Roughly every 6 weeks we have a new release with upgraded functionality and new features that could benefit you and your team. Stay updated by regularly visiting the release notes section on the Viedoc web site.