4 Enter Data

To enter data into OpenClinica, you must do the following:

  • Add a Participant 
  • Schedule an Event
  • Enter data

Instructions for each of these tasks are addressed below.

Add a Participant

Studies can be configured to allow you to manually enter the Participant ID, to automatically generate a Participant ID based on a predefined format template, or for Data Managers to add Participants in batch.

To batch load participants (only available to Administrators), from the User Menu, select Administration. Then click Web Services Information. This is a link to the interactive Web Services documentation.

To add Participants individually, follow the steps below:

To add a new participant, there are two options:

  • From the Tasks Menu, select Add Participant or click Add New Participant above the matrix:

Note: If you do not see the links to add a Participant, either your user role doesn't allow adding Participants or a Participant Cap has been set for your study and the maximum number of Participants has already been met.

With either option, the Add New Participant form displays.

If your study was set up to accept manual entry of Participant ID, type the Participant ID and click Add:

If your study was set up for automatically generating the Participant ID, click Add and the Participant ID will be generated based on an ID format defined for your study:

In either case, when you click Add, the Participant Details page displays with the Participant ID in the upper left corner.

From there you can schedule events and begin entering data.

Schedule an Event

Once a Participant has been added, you can schedule events and start to enter data.

  • To schedule an event in the Visits section of the the Participant Details page, click Add New:

The Schedule Study Event page displays:

Select a Study Event Definition from the drop-down list and provide at least a Start Date for the event.

  • The current date is provided as a default Start Date - edit that value as needed.
  • To schedule additional Events, click Schedule Another Event and complete that Event information.
  • To enter data, click Proceed to Enter Data. This returns you to the Participant Details page, where you can begin to enter data.

Note: For non-visit based Events (Common Events, such as Adverse Events and Concomitant Medications), a visit date is not required; in those sections (at the bottom of the Participant Details page - if created for your study), Add New opens the form directly.

  • To schedule an event from the Participant Matrix, click on the icon for the Participant and Event that you'd like to schedule and select Schedule

The Schedule Study Event page displays, as above, except that the Study Event Definition field is populated with the Event that you had selected, and the Start Date is defaulted to the current date. Update those values as needed, and schedule additional Events if you'd like. Otherwise, click Proceed to Enter Data to return to the Participant Details page, where you can begin to enter data.

Enter Data

Data can be entered directly into electronic case report forms (eCRFs), or imported into eCRFs using XML. Instructions for both of these methods are addressed in the topics below.

 

Approved for publication by Benjamin Baumann (bbaumann), Principal. Signed on 2018-09-14 9:03AM

Not valid unless obtained from the OpenClinica document management system on the day of use.