Create a Study & Add Study Products, Countries, Sites

Who can complete this task?
  • Clinical Basics: CTMS Vault Admin, Clinical Basics: Study Manager

After creating users, you are now ready to create and set up a study. Setting up a study involves associating study personnel, products, countries and sites, as well as planning the initial milestones and metrics and creating visit definitions.

Create a Study

To create a study:

  1. Navigate to Study Management > Studies and click Create.

    Clicking Create button in Study Management > Studies

  2. Complete the required study details and click Save.

Add Study Products

To add study products:

  1. Starting from the study record, open the Study Products section and click Create.

    Clicking Create button in Study Products

  2. Select a Product and click Save.

    Selecting Product and clicking Save

  3. Add additional products to the study if necessary.

Add Study Countries

To add study countries:

  1. Starting from the study record, open the Study Countries section and click Create.

    Clicking Create button in Study Countries

  2. Select a Study Country and click Save.

    Selecting Country and clicking Save

  3. Add additional study countries to the study if necessary.

Add Study Sites

To add study sites:

  1. Starting from the study record, open the Study Countries section and click the Country you want to add sites to.

    Selecting Country link

  2. Open the Study Sites section and click Create.

    Clicking Create button in Study Sites

  3. Enter the Study Site Number.

  4. Select the Organization and Primary Location.

  5. Click Save.

    Entering Site Number, Organization, Primary Location and clicking Save

  6. Add additional study sites to the country if necessary.

What is the next step?

Add Visit Definitions