Overview
The Egnyte eTMF (Electronic Trial Master File) App allows study setup to begin by adding a study to the system. This article explains how to create a new study from the home screen.
Who Can Create Studies
- Egnyte Domain Administrators and eTMF Administrators can create new studies in the eTMF app.
Create a Study
- From the My Studies home screen, click Add a new study.
- Enter a Study Name and Study ID on the Study Creation screen.
- Choose the study type from the Study Type drop-down.
- Select Yes or No from the Investigator-Initiated Study drop-down.
Indicate whether configuration of an existing Study should be duplicated. After checking this option and selecting a source study, admins may choose to duplicate one or both of the following:
- Country/Site Configuration: All countries and sites from the source study, including field values from the Country Details and Site Details tabs, will be recreated in the new study. Duplicated countries and sites will be set to Inactive status by default, and permissions will not be copied.
- Artifact Configuration: Artifact checkbox selections from the source study, including custom artifacts and blinding designations, will be applied to the new study. Any artifacts that do not apply to the new study's type will be skipped, and artifacts with no equivalent in the source study will default to their standard values.
- Click Create. (Admins can also assign permissions to groups in the Who can manage this level
field later.) - The new study will be created and will be visible on the My Studies screen.
Setting Up A Country For A Trial
- To create/set up a new country for the trial, first choose the study from the My Studies home screen. Then click Trial to open the trial screen.
- Fill in the empty fields on the Trial screen and click Save changes.
- Choose the Countries tab on top of the Trial screen and click +Add a new country.
- Fill the country screen and click Create. The country will show up under Trial after it has been created.
- Admins can add additional countries by clicking +Add a new country.
Setting Up A Site For A Trial
- New site setup is very similar to setting up a country: From the country screen, choose the Sites tab and click +Add a new site.
- Fill in the fields in the popup site screen and click Create.
- Admins can add additional site by clicking +Add a new site.