Manage Study

Somebody should be responsible for the management of the OpenClinica study during the execution phase. The tasks for this person includes among others the following:

-      Create a new CRF version

-      Migrate data from an older to a new CRF version

-      Remove CRFs (not permanently)

-      Change Study Subject ID

-      Create a new site in an OpenClinica study

-      Assign and Remove existing users to OpenClinica Study

-      Reassign subject to another site in OpenClinica

-      Request new user accounts

There are quick reference guides available for most of these management tasks and will be described in the Frequently Asked Question section. To request new user accounts see step ‘Request study or user account in preparation phase.

Please contact the TraIT Servicedesk if you want to delete CRFs permanently or if you want to correct a date of birth. These tasks can not be performed by a data manager or study director.

To avoid late stage problems it is very important to test changes of an ongoing study in the sandbox environment (e.g. a new CRF, an updated CRF or a new or modified rule). Often testing is neglected and this could cause serious problems after years of data collection!


Next step: Central Data Management

Back to: Execution Phase