![]() ![]() Early Termination, since a Participant can only terminate once.) To Enter Study Designer:Ĭlick the Design button on the My Studies screen. AEs and ConMeds, since Participants might have more than one AE or ConMed) or Non-Repeating Events (e.g. For example, Adverse Event (AE), Concomitant Medication (ConMed), or Early Termination Events.Ĭommon Events can be defined as either Repeating Events (e.g. These visits are associated with a schedule that is outlined in the study protocol, and each visit has a specific set of Forms that are collected.Ĭommon Events are used to collect information that is not necessarily related to a scheduled visit date. In a typical interventional clinical trial, most Events are defined as Visit-Based Events, such as: Week 2, Week 6, and Monthly Follow-up, in which the Week 2 visit occurs two weeks after the Baseline visit, the Week 6 visit occurs six weeks after Baseline, etc. Visit-Based: An Event that is scheduled to occur within the study and is associated with a visit date.Ĭommon: An Event that isn’t necessarily associated with a visit but may occur any time throughout the study. Events and the Participant Details ScreenĮvents appear on the Participant Details Screen as follows:Įach Event Can be Defined as One of the Following Types: An event might or might not be connected to a real-world visit.Ī Form or eCRF (electronic Case Report From) is a group of fields for collecting Participant data.Īn Event could be a follow-up visit that occurs during a study.Ī Form could be used to record a Participants vital signs, capture a patients informed consent, track drug accountability, etc. EventsĪn Event is a group of Forms that are used in your Study. This page covers all of these features (excluding Library Management) in more detail below. You can also select by permission tags, labels, and members. Archive: Expands the right sidebar, which allows you to select Forms to copy or archive.Multi-Select: Expands the right sidebar, which allows you to select multiple forms by permission tags, labels, and members.Search: Expands the right sidebar, which allows you to enter text to search for Forms in the current study.Filter: Expands the right sidebar, which allows you to filter Forms by permission tags, labels and members.Table Design: Allows you to add custom columns to the Participant Matrix and Queries Table or define Data Review Tables.Form Template: Allows you to download the Form Template.(See Content Library for more information) Library Management: Data Managers who are Administrators can access the library from here.This icon will appear adjacent to one of the previous two when an event is a repeating event.įeatures Accessible from the Header Navigation: Monthly Follow-Up for Disease-Free Survival (repeating)Īn event that is not necessarily associated with a visit date.Įarly Withdrawal or Termination (non-repeating) Īn event that repeats in your study, either a known or unknown, number of times. The event can be repeating or non-repeating. IconĪn event that is associated with a visit date. In Study Designer, one or multiple icons appear after the name of the Event. You can use the buttons on the upper right side of the screen to access settings, Share your study, Publish your study, or Go to your study in Test or Production. The header bar displays the status of your study, provides a link to the My Studies screen, and gives you access to the user menu. Dragging a form from one event to another will automatically copy that form into the new event while dragging the entire event will reorder the event (including its associated forms) to its new location. You can drag-and-drop events and forms to reorganize your study. You must have a User Role of Data Manager to access Study Designer.įorms appear as Form Cards under the title of the associated event. To access Study Designer, click Design on the My Studies screen. Study Designer contains a set of features that allow you to define, configure, and manage Events, Forms and other components for your study. ![]()
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