The Egnyte eTMF (Electronic Trial Master File) App lets you begin setting up your eTMF structure by adding your study in the system. This article shows you 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 ID on the Study Creation screen.
- Choose the study type for your study from the Study Type drop-down.
- Select Yes or No from the Investigator-Initiated Study drop-down.
- Click Create. (You can also assign permissions to groups in the Who can manage this level
- Your new study is now created on the My Studies screen.
Setting Up A Country For A Trial
- To create/set up a new country for your trial, first choose the study that has been created 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.
- You 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.
- You can add additional site by clicking +Add a new site.