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Creating a New Study in the Egnyte eTMF App



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

  1. From the My Studies home screen, click Add a new study.


  2. Enter a study name and ID on the Study Creation screen.  


  3. Choose the study type for your study from the Study Type drop-down. 


  4. Select Yes or No from the Investigator-Initiated Study drop-down.  


  5. Click Create. (You can also assign permissions to groups in the Who can manage this level
    field later.


  6. Your new study is now created on the My Studies screen.


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.  Then click Trial to open the trial screen.

    eTMF_New Study_6.png
    eTMF_New Study_9.png

  2. Fill in the empty fields on the Trial screen and click Save changes.

    eTMF_New Study_8.png

  3. Choose the Countries tab on top of the Trial screen and click +Add a new country.

    eTMF_New Study_12.png

  4. Fill the country screen and click Create. The country will show up under Trial after it has been created.

    eTMF_New Study_10.png
    eTMF_New Study_11.png

  5. You can add additional countries by clicking +Add a new country.

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.

    eTMF_New Study_13.png

  2. Fill in the fields in the popup site screen and click Create.

    eTMF_New Study_14.png

  3. You can add additional site by clicking +Add a new site.

    eTMF_New Study_15.png
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