Projecting Visits, Anchor Dates, and Visit Dates
Setting the Anchor Date
Anchor Dates are used to project a subject's visit schedule for a period of the study, or for the duration of the study. The first thing you will do before entering any data is set the subject’s visit schedule by selecting the anchor date for the very first study visit. The system will use this date to project the subject’s visit schedule for the study.
To set the Anchor Date, click on “Set Date” and select the appropriate Anchor Date. Typically, the initial Anchor Date is the day Screening started.
Modifying Anchor Dates
Once set, an Anchor Date cannot be modified. Subsequent Anchor Dates represented in blue can be modified to re-project subsequent expected visit dates and visit windows. It is often the case that the anchor date will need to be updated to match the Enrollment or Randomization date to ensure the Visit Schedule is accurate for the duration of the study. When a subsequent Anchor Date is updated, future visit windows will be re-projected based on the new Anchor Date. To modify an Anchor Date, click on it and select the appropriate date.
Visit Windows
Anchor Dates are used for projecting the visit schedule and used as "soft" visit windows. I.e. any visit date can be entered regardless of the Anchor Date, however, if an actual visit date is chosen that is outside of the window, the system will prompt for entry of reason visit occurred outside of window.
Setting Visit Dates
To set the actual date for a visit, click on the visit name and then specify the date and time that the visit occurred. You will only be prompted to specify the actual date the first time that the visit is opened. If the visit time is unknown, we suggest using the time that the first procedure started or 12:00 AM as a default.
Once a reference or actual date is set it cannot be changed. You will be asked to confirm the date after it is entered. Please ensure that the date is correct prior to confirming.
Visual Indicators
- Projected dates will be displayed in either black or blue text
- Black indicates a date that has been set as a reference date.
- Blue indicates that the visit can be used as a reference date if a re-projection is necessary.
- Projected dates will be surrounded by parenthesis when the actual date has been set for the visit.
- Actual dates will be displayed in green text.
- Earliest and latest dates of an allowable window will be displayed before and after the projected and actual dates.