Using the Egnyte eTMF (Electronic Trial Master File) app, Study Managers can quickly set up eTMF study structures for each country and site where the clinical trials are run. The sections below show how countries and sites are created in the eTMF app.
Who Can Create Studies
- eTMF Administrators and Study Managers can create new studies in the eTMF app. (see eTMF Roles and Permissions)
Setting Up a Country for a Trial
1. To create/set up a new country for your trial, first choose the study that has been created from the My Studies home screen (see Creating a New Study in the Egnyte eTMF App). Then click Trial to open the trial screen.
2. Fill in the empty fields on the Trial screen and click Save changes.
3. Choose the Countries tab on top of the Trial screen and click +Add a new country.
4. Fill the country screen and click Create. The country will show up under Trial after it has been created.
You can add additional countries by clicking the +Add a new country button.
Setting Up a Site for a Trial
1. 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.
2. Fill in the fields in the popup site screen and click Create.
You can add additional site by clicking the +Add a new site button.