How to Review a Calendar Build

  1. Go to Menu > Protocols > PC Console and start entering your Protocol No. in the Select Protocol field and select it from the drop down.
  2. Once your protocol is pulled up, go to the Treatment vertical tab to make sure the study arms are accurate.
  3. Next, go to eCRFs/Calendars > Specifications

  4. You should now see something like the below image.  You can review the calendar procedures and time points on this Calendar tab.

    1. It can save time if you print off the protocol calendar and compare with the OnCore calendar. Then, go one procedure at a time across all arms. 
    2. If there are any footnotes below the calendar, check for accuracy. The OnCore team only adds footnotes explicitly requested by the study team or for utility purposes; they will not add all footnotes from the protocol.
    3. Per the protocol, make sure any designated +/- visit tolerance windows are accounted for. You can check by clicking on any columned hyperlink from the full calendar view (ie. Baseline, treatment, surgery). 
      1. Example: If Day 1 of each Chemotherapy cycle has a window of + or - 1 day, then you will see the below when you click on the Chemotherapy segment.
    4. If you do not see a calendar, but instead see the below, this means that a calendar has not been completed for this protocol.  


  5. To review the milestone-specific components of the protocol calendar, click on the Treatment Visits vertical tab. 
    1. Subject Milestones: The Start Date can be any of the following statuses and these calendar segments are triggered as a subject enters these statuses:
      1. Consent Signed *
      2. On Study *
      3. On Arm
      4. On Treatment**
      5. Off Treatment *
      6. Off Arm
      7. Off Study *
      8. On Follow Up**
      9. Date of Progression**
      10. End of Previous (allows one segment to immediately follow another segment)
        Applied to all treatment arms (i.e. cannot be arm specific)
        ** Segments that can be open-ended, if needed. Open-ended means there is no maximum number of treatment cycles a subject can have, so more treatment cycles will populate on the subject's calendar, as needed.

  6. Specification Status: The status and version can be seen just below the header of the Study Specification page. 
    1. When a specification is created, it has a status of "New" and a version number "1". 
    2. Specifications proceed in order through the following statuses by protocol staff with the following roles:
      1. New
      2. Complete (WU Coverage Analyst)
      3. Initial MCA Signoff (WU Coverage Analyst)
      4. Budget Team Signoff (Financial Coordinator)
      5. Released (WU Coverage Analyst)

Need more help? Contact the OnCore Support Team: oncore@wustl.edu