Create a study

For details on creating a study, see this video:

  1. On the Icon shows a clipboard. Study Manager page, click Icon is a plus sign. Add in the Studies pane.

  2. Enter a name and description for the study.

  3. Template: If selected, this study is available as a template for other studies. You can select this setting later, after testing the study.

    If the study is available as a template, edit the description to help others decide whether to select this study as a template. The maximum length is 2000.

  4. Therapeutic Area (or other category): Select the category the study belongs to. The label for this field and the choices available are customizable by your company.

  5. Study Size: Select Small, Medium, or Large to indicate the amount of patient data to be collected in this study relative to other studies. The system uses this value to help determine which partition to use for this study's data in certain cross-study internal tables.

    Tip:

    You cannot change this value after saving.

  6. Click OK.

  7. If you are using Oracle Thesaurus Management System as a coding system, click the TMS tab and see Assign dictionaries for coding (optional).

Next: Create clinical data models. Do one or both: