Study Manager - Creating or Copying Studies

Owned by TK Support, created
Last updated: Sept 17, 2021 by TK Support
3 min read

Every study created is a copy of another study within the host account. This is done in the Study Manager from the web or mobile app.

Access to this function is based on host level permissions granted by a host Administrator on the account.

 

Creating Studies

The annotations above are as follows:

  1. Study Name

  2. Sponsor Name

  3. Study Type

  4. Default Study - This is where you choose which of your existing studies you would like to copy. This dropdown will only list studies you are part of.

  5. Optional: Select if you would like to include sites/user assignments from the source study or subject data from the source study. 

  6. Create your New Study!

If no options in step 5 are selected, read below about what gets copied from the source study.

 

 

From the home screen, access the host management menu:

Tap the option to add a new study.

Complete the fields on the form. The “Default Study” is the study which you are choosing to copy from as a starting point for the new one.

 

 

What gets copied from the source study when creating a new study

If you are creating your first study, a template is already setup with a common eCRF library, 21 CFR Part 11 study configuration, user roles and permissions.

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

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

  • Randomization tables

  • eDiary configurations

  • Inventory configurations

 

Editing Study Details

In the Study Manager on the web, use the edit link in the table to edit the study name and other available details.

In the Study Manager on the mobile app, tap on the desired study name and see the resulting screen to edit available details.

Making a Study Available For Public Participation

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.

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

 

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.

 

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