Add Event

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Build Steps:

  1. Add Study
  2. Add Forms
  3. Deploy Study
  4. Publish Forms
  5. Add Events
  6. Add Groups
  7. Add Rules
  8. Add Sites
  9. Add Users

Events are a series of site visits or clinical events during which patient data is collected over the course of a study. There are four types of events:

  • Scheduled events are expected to occur at a pre-determined schedule, according to the study protocol.
  • Unscheduled events do not have a pre-determined schedule. For example, an unexpected office visit.
  • eSource events are similar to Scheduled events, but they allow you to collect data in real time. You do not need to collect data on a source document first.
  • Common events collect data forms, but they are not expected to be associated with a particular time. Examples might include Protocol Deviations, Concomitant Medications and Adverse Events.
  • Calendared events automatically schedule follow-up events based on a reference event, according to intervals set in the study protocol.

To add an event:

  1. Click Events in the Left Menu
  2. Click the + icon in the Events page.
  3. Complete the following. Required fields are marked with an asterisk.
Field Description
Name * The name of the event.
Description The description of the event.
Type * Select the event type from the dropdown list: eSource*, Scheduled, Unscheduled, Common, Calendared.* Requires the eSource feature to be enabled.
Repeating If you selected Scheduled, Unscheduled or Common as the event type, select Yes if the event is repeating.Repeating indicates this event can occur multiple times for a subject within the study.
Reference Event If you selected Calendared, complete the following:
Reference Event – Check the box if this event is a reference event.If this is not a reference event, complete the following:

  • Day Schedule – The number of days this event will be automatically scheduled after the last reference event completes.
  • Day Max – The maximum days that this event can be completed after the last reference event is completed. Completing this event later generates an automatic query.
  • Day Min – The minimum days that this event can be completed after the last reference event completes. Completing this event early generates an automatic query.
  • Day Email – The number of days a reminder email is sent out after the last reference visit is completed.
  • User Name – Type a valid user name to be reminded by email for the visit.
Category Specify a category for the event. The category is generally used to indicate the study phase. For example, Screening, PreTreatment, Treatment, FollowUp.
  1. Click Continue.
  2. Select the CRFs to attach to the event by clicking the corresponding checkboxes.
  3. Click Continue.
  4. For each of the selected CRFs, complete the following.
Field Description
Required Check the box if the CRF must be completed for the event.
Data Entry Quality Select:

  • Double data entry   –Two users must enter the same data for the CRF.
  • CRF data evaluation – The data must be evaluated by a Study Evaluator.  If data is changed, a Reason For Change must be created.
Password Required Check the box if the user must enter their password to save the data for the CRF.
Default Version If there are more than one version of the CRF, select the version from the dropdown that should default for the event.
Accept New CRF Versions For Sites When this checkbox is checked and  a new CRF version is available, sites can be automatically be updated.  This function can be disabled on a per-site basis.
Hide CRF Check the box if the CRF should only be viewable at the study level. If this option is selected, sites cannot access the CRF.
Source Data Verification Select how much, if any, of the data on the CRF requires source data verification. You can select:

  • Entire CRF – All CRF items must be monitored.
  • Specific items – Specific CRF items must be monitored.  These items must be marked for source data verification in Form Studio.  These setting can be overridden in Captivate.
  • Not Required – The CRF is not included in the list of CRF to be source data verified.
Send Email when CRF is
  • Complete to send an email when the CRF is completed.
Tabbing inside tables To control the cursor movement when tabbing inside tables, select:

  • Left to Right – This is the default.
  • Top to Bottom
  1. Click Continue.
  2. Review the Event to be defined.
  3. If you’re satisfied, click Submit.
  4. You can change the order the events will appear on the Subject Matrix by dragging and dropping the events in the order desired.
  5. You can also change the order of the CRFs attached to an event by dragging and dropping a CRF in the order desired within the same event.

Repeat this process to create all the events with the associated forms, according to your study protocol.

Note:

  • Event must be added after deploying a study.