Study Definition module

Creating a new study

To create a new study, you need the 'Create study' permission

1. Log in to Study Definition, selecting the database in which you want the new study to be created.

2. Select File > New. The New Study window is displayed.

3. Enter a name for the new study. This will be used as the unique identifier for the study. Tips on naming  

   • Study names create a distinction between different studies. It is essential that you give each study a unique name. The name may contain up to 15 letters or numbers, but it must begin with a letter.

   • You may use any combination of upper or lowercase letters, but remember that searches do not distinguish between cases.

   • The name must not be a name that is already in use as a code.

4. Select a culture from the drop down list. The culture reflects the language in which you will be designing your study.

5. Click OK to create the new study or Cancel to abort.

6. The new study is created and the Study Definition window is displayed. You can enter the relevant information in here now, or you can return to it at any time.

7. Click OK to save any changes and close the window.

8. You are now ready to build your study. You will not be able to use your study for Data Entry until you have created at least one visit containing at least one eForm.

Renaming a study

If you wish to rename your study, you can make a copy of the study under a new name and then delete the original version.

Warning: Copying a study does not copy any subject data already entered for the study. It is not possible to directly copy subject data from one study to another.

Changing a study

Once you have created a study and used it to create subjects in Data Entry, there are restrictions on the further changes you can make to the study without invalidating the subjects already created. During the development of a study, you will not always be able to re-open subjects created with earlier versions of the study.

When the study status is In preparation, you can make any changes you like to the study, but some of your study subjects may not open in Data Entry (for example if you have deleted questions, eForms or visits for which there was data already collected).

If the study status is Open, indicating that you are now collecting live data, there are several changes you are not allowed to make to the study, to prevent invalidating existing subjects. Click here for details of changes which can be made once a study is open for subject data entry.

Related Topics

Editing the study details