Project Pre-Launch Playbook: Where and How to Get Started

In this playbook, we will discuss frequently asked questions from client teams and their observed best practices as they prepare to configure/build a project in MyDataHelps Designer.

Getting Started and FAQ

The project team lead (e.g., Research Coordinator, Project Manager) will typically have a set of questions to answer before configuration in MyDataHelps Designer can begin. Many teams find it useful to first meet internally and discuss the questions below as part of their protocol finalization process. It is recommended you thoroughly plan your project before you begin the configuration process. If you have questions about specific platform capabilities, please see the New Project Checklist for a comprehensive list of MyDataHelps functionality.

Enrollment (e.g., MyDataHelps Registration) 

How will I enroll participants in my project?

• By Invite: This can be done via email invitation in MyDataHelps Designer by preloading participant information (including email addresses) via CSV file, or you may send the invitations using a third party email application.
• Open Enrollment: If you do not have email addresses for participants, you may wish to post a project-specific QR code in a public place for open enrollment.
• In Person: If participants are not able to access a phone or computer during enrollment (e.g., in the surgical room), you may wish to use an iPad to enroll them using MyDataHelps Designer's shared device mode.
• For more details on enrollment models, as well as examples, see Enrollment Best Practices.

How will the project uniquely identify participants?

• By default, MyDataHelps Designer will assign a participant identifier to each new participant invited via the MyDataHelps Designer invitation module. However, you may wish to also include your own participant identifier. This can be added when inviting participants by creating a Custom Field and adding a CSV column using that custom field name.
• MyDataHelps Designer automatically includes the prefix “MDH” followed by eight random digits (e.g., MDH-0000-0000). If you would like to create your own prefix, update the “Participant Identifier Prefix” field in your project settings. MyDataHelps will then add eight random numbers to make each participant ID unique.

Will there be only one invitation or will subsequent communications take place to nudge participants to enroll? 

• After sending the initial invitation, you may decide to send a series of notifications to "nudge" the participants to join your project. You can create these within the notifications module and manually send them to participants or schedule them to be delivered at specific times.

Consent (First Step After App Registration)

Will the consent be paper based or electronically submitted (e.g., using the MyDataHelps participant facing app)?

• MyDataHelps Designer allows you to enroll participants electronically using our eConsent form. You may decide to include an electronic signature as part of this process. 

Will participants need to complete multiple consent documents?

• You may choose to display any number of consent forms by using the Consent Step Type.

Will there be eligibility criteria to participate in the study (e.g., participant must be over 18 years old)? 

• By default, new projects will contain a sample consent with eligibility steps. You can choose to update (or delete) these as needed for your project; however, if you update these, you will need to update the validation logic accordingly as well.

Is your study regulated by the Federal Drug Administration (FDA)?

• If your study is subject to FDA approval, you will need to ensure the study is set up in MyDataHelps in such a way that it is FDA compliant, meaning it follows requirements detailed in the 21 CFR Part 11 regulation. This regulation ensures that studies are capturing electronic records and e-signatures appropriately. MyDataHelps supports 21 CFR Part 11 compliance. Refer to the Creating eConsent & Enrollment Surveys article for more information on how to set up your project to be compliant. 

Setting Initial Surveys and Active Tasks

What surveys will you design and send to participants?

• MyDataHelps Designer supports a wide range of step (i.e. question) types allowing great flexibility in creating any survey or instrument needed for your project. Optionally, you may visit the MyDataHelps Designer Survey Store and import many sample surveys or surveys submitted by previous clients (e.g., PHQ-9, PROMIS). 

What frequency or cadence will you send these surveys (using the RKS schedule interface)? 

• Once you have decided on a frequency and cadence for your survey delivery, you will configure your survey schedule using the MyDataHelps Designer scheduler module. 

Wearable Devices (Sensor) and EHR Data

Will you be capturing wearable device sensor data (e.g., Fitbit sleep, Apple Watch HR, Google Fit steps) as part of this project? 

• In the project settings, you may set which sensor/device data you wish to collect from Apple Health, Google Fit, and Fitbit. For Apple Health and Google Fit, you may select your specific device data to be collected. For Fitbit, all device data will be enabled, and it is up to the participant to choose which they consent to share with MyDataHelps.
• We recommend setting up data exports before you begin collecting participant data, to minimize the size of your first data export.

Which devices (brand and model) will your participants be wearing in this project?

• MyDataHelps Designer supports Fitbit devices and those devices compatible with Apple Health and Google Fit. Note that MyDataHelps Designer is at the mercy of what data the device manufacturer will share with Apple Health/Google Fit, and what data Apple Health/Google Fit will share with MyDataHelps Designer. Visit your device manufacturer's website or the Apple Health/Google Fit documentation to understand compatibility.

Will you be allowing participants to access their EHR data as part of this project?

• Certain projects require the ability for participants to link to their Electronic Health Record (EHR) accounts (using MyDataHelps Designer FHIR connectivity standards). If this is the case for your project, please contact CareEvolution.
• If your project includes Apple users, you can choose to collect Apple HealthKit Clinical Records as well.

Participant Dashboard, Goal Setting, and Incentives

Do you plan to include a participant facing dashboard as part of this project? For example, device data graphs such as steps, HR, or sleep; survey answers, individual vs. population comparisons; ancestry report (generated by your team).

• MyDataHelps offers the ability to display results and data (e.g., device/sensor/wearable data, survey, etc.) back to the participants. An example of this is a mental health study where the project team wishes to deliver a table showing the correlation of daily mood vs. nightly sleep. If you are interested in a participant facing dashboard, please contact CareEvolution to understand what is configurable.

Participant Notifications (e.g., Just In Time Adaptive Interventions)

What participant notifications will this project require?

• You may wish to send information, nudges, or Just In Time Adaptive Interventions (JITAIs) to your participants. MyDataHelps Designer currently supports email, push, and SMS notifications.

What will trigger these notifications? At what frequency should they be set?

• Once you know your notification triggers (e.g., send notification immediately upon enrollment), information, and frequency, you can configure the notifications and then create schedules to automate the notification delivery.

Duration of the Project

How long will participants engage with the project (e.g. until a specific date, relative to their enrollment date)? See End of Project Playbook for more information.

• Define when to stop collecting sensor data and sending notifications to participants within the End of Project settings.
• Close any outstanding surveys.
• Notify participants of any important dates or follow-up information.

Next Steps: Begin Designing Your Project

After the project protocol has been finalized, the next step is for your research team to set up a MyDataHelps Designer account and either join or create a workspace. We recommend starting with a "Dry Run" project. This can be used for all of your initial configuration and testing.

Testing Your Project

Depending on the scope, projects can require three to four weeks of thorough testing before enrolling participants. We recommend creating a "Dry Run" project when you first begin project configuration. A “Dry Run” project is one that is configured and kept specifically for testing. This project will typically contain “Dry Run” as part of the project name to denote that it is a testing project. 

Once the “Dry Run” project has been thoroughly tested by the project team, it should be copied and renamed to a “Production” project. The production project should be used to enroll participants once the project is live, and dry run can be used strictly for testing any potential changes. See Testing Your Project for more information.

Enrolling Participants

Once you have thoroughly tested both Dry Run and Production, you are ready to start enrolling participants in production. Please note, projects are free for up to 100 participants, but will require a license if you wish to exceed that number. For more information regarding licensing, please contact CareEvolution.

Configuration Best Practices

The MyDataHelps platform is designed to enable project teams to configure and manage their own content (e.g., consent and surveys) and project settings (e.g., which device data to collect?) over the duration of the project. However, there are some optional advanced project elements that you may require CareEvolution to implement. The New Project Checklist article details which elements your team can configure and which may require assistance.

If your team has specific questions regarding advanced configuration or capabilities not currently available on our platform, please contact CareEvolution with your project protocol and specific request details.