Study Manager

Viewing a List of Studies on a Host Account and Making Copies of Studies Within the Host

The Study Manager screen shows all studies that exist on the current Host account, along with the production status of each one. It is also where new copies of existing studies can be created.

Table of Contents

Accessing the Study Manager

Editing A Study Name

Checking the Production Status

Copying a Study

Updating a Copied Study Back to the First Version

Making the Study Publicly Available For Participant Registration

Accessing the Study Manager

Web Browser:

Mobile App:

This will open the table of studies that exist on the current host, even if the current user is not a member of all studies.

Editing A Study Name

Within the list of studies, tap the edit button, or if one is not present tap the study name to edit its details. This will allow for changing the study name, sponsor name, and study type.

Web Browser:

Mobile App:

(after tapping a study to view the details)

Checking the Production Status

There are two study types: Testing and Production. An example is shown in the table above under Editing a Study Name.

Only production studies can be moved to Live status. Study types are managed by Crucial Data Solutions based on licensing. 

Copying a Study

Web Browser:

Fill out the form with a study and sponsor name as shown below. These can be changed later. The important part is choosing the Default study or the study that will be copied from as a template.

Mobile App:

TrialKit comes with an initial study template consisting of a common eCRF library, 21 CFR Part 11 study configurations, and standard user roles and permissions.

From the template, you can simply begin registering subjects to look at the study workflow.

If this is not the first study, the default study selected (source study) will be what gets copied. This includes all forms and study settings from the source study.

The following elements are not copied:

• Randomization tables
• eDiary configurations
• Inventory configurations
• Informed consent configuration

Updating a Copied Versioned Study Back to the First Version

When copying a previous study that already contains multiple versions, the new copy will end up with those same versions in place. This section covers the steps for reversing the versions back to a single one, where that single version is the most recent version of the source study.

1. Copy a study with multiple versions
2. Create a new form library titled after the study, for easy future reference
3. Open the new study
4. From the Form Builder, export all the most recent versions of forms to the new form library
5. Open the scheduled visits configuration and take a screenshot of the visit design. This will be used later to verify the visit schedule does not lose any forms.
6. Open the Version Manager page and Un-include all sites from all versions
7. Open the study configuration and un-publish/delete all versions of the new study in reverse order. Continue to do this until you are down to the first version, which should be "In Development".
8. From the Form Builder page, delete all existing forms
9. Import all the forms from the form library
10. Use the screenshot from step 5 to reference setting up the scheduled visits with the forms that were just imported

Make any other necessary changes in the study configuration such as randomization, notifications, review levels, etc.

Making the Study Publicly Available For Participant Registration

Setting up a study for public participant enrollment can currently only be configured on the mobile app Study Manager. This feature makes it so the study gets listed for public visibility on the TrialKit app when Participants are signing in.

If enabled, a security code (alpha-numeric) can also be defined. This prevents undesired registrants. The information for study signup and enrollment code can be provided via any means, such as an external public web page.

Mobile App:

When this is enabled, users on TrialKit will see this when signing in as Participant users:

 

A list of publicly available studies will be displayed to select from, along with the description that was provided by the Administrator. Once selected, the user will need to enter the code (if required) as shown below.

When a participant registers they will be sent an automatic system email to verify their email address, with a 60-minute time limit. Once verified, the subject will be created in the study with a PIN number generated to sign in with.

The system verification email can optionally contain any attachments for instructional purposes of the study (e.g. Registry synopsis or instructions for next steps). To do this, simply upload a file within the Study Documents which contains the text “Instructions For Use” within the file name.