Use the Add Menu

The Add menu enables you to add the following items to the Participant Visit Schedule and/or the Log:

• Protocol defined events - These are included in the study protocol and may insert or replace future visits, or be added only to collect data. Default protocol defined events include Reportable Adverse Events, Unscheduled Visits, or End of Study. Some protocols also contain additional protocol defined events such as pregnancy, death, or specific clinical findings.

• Unplanned activity - These may include things such as unplanned tests or procedures.

• Unplanned visit - These include ad-hoc visits that were not on the visit schedule.

• Participant notes - These are participant level notes. They are related to the study participant rather than a specific visit.

• Washout - This is a period of time when treatment is paused to allow the effects of a medication or treatment to be eliminated.

• Deviation - These are any departures from the study procedure or treatment plan as specified in the IRB-approved protocol such as failing to document informed consent or enrolling a participant that did not meet all of the eligibility criteria.

• Adverse event - This includes any untoward medical occurrence associated with the use of a clinical intervention in humans, whether or not considered intervention related.