After the OnCore study start up form is submitted, YCCI’s OnCore team builds a calendar in OnCore. It is the responsibility of the PI and study team to ensure the OnCore team has all the necessary information to complete the OnCore Calendar. The information the PI must provide includes:
- The protocol, sponsor informed consent form, sponsor proposed budget, and lab manual if available;
- Clarifications regarding questions related to the protocol.
Once the OnCore Calendar Build is complete, the PI and study team is required to sign off indicating her/his approval.
Initial OnCore Calendar Builds and subsequent revisions to the Calendar e.g., due to a protocol amendment(s) can only be released after IRB approval.