How to Review a Calendar Build
- Go to Menu >Â Protocols > PC Console and start entering your Protocol No. in the Select Protocol field and select it from the drop down.
- Once your protocol is pulled up, go to the Treatment vertical tab to make sure the study arms are accurate.
- Next, go to eCRFs/Calendars > Specifications
- You should now see something like the below image. Select which arm(s) you want to view.
- You can review the calendar procedures and time points on this Calendar tab.
- 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.Â
- 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.
- 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).Â
- 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.
- 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.
- If you do not see a calendar, but instead see the below, this means that a calendar has not been completed for this protocol. Â
- To review the milestone-specific components of the protocol calendar, click on the Treatment Visits vertical tab.Â
- Subject Milestones:Â The Start Date can be any of the following statuses and these calendar segments are triggered as a subject enters these statuses:
- Consent Signed *
- On Study *
- On Arm
- On Treatment**
- Off Treatment *
- Off Arm
- Off Study *
- On Follow Up**
- Date of Progression**
- 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.
- Subject Milestones:Â The Start Date can be any of the following statuses and these calendar segments are triggered as a subject enters these statuses:
- Specification Status: The status and version can be seen just below the header of the Study Specification page.Â
- When a specification is created, it has a status of "New" and a version number "1".Â
- Specifications proceed in order through the following statuses by protocol staff with the following roles:
- New
- Complete (WU Coverage Analyst)
- Initial MCA Signoff (WU Coverage Analyst)
- Budget Team Signoff (Financial Coordinator)
- Released (WU Coverage Analyst)
Need more help? Contact the OnCore Support Team: oncore@wustl.edu