The Standard Protocol Related Events follow the life-cycle of a study: Start-up, Maintenance and Closer-out. To provide the needed flexibility to accommodate the various types and complexity of studies, each life-cycle phase is broken out in to the:
Base – the costs of those activities that are completed for every protocol. For examples IRB submission.
Add-on’s – additional activities that can be added to each protocol only if needed. For example, not all studies will use a pharmacy, so the pharmacy start-up fee would be an add-on to the start-up base only for those studies using a pharmacy.
In the case of the Maintenance life cycle phase, the add-on’s are split into two groups to leverage OnCore functionality for sponsor invoicing. In addition to the add-on’s group, a second group called “as-incurred” is also available in the Maintenance life cycle.
The difference between these groups is that the add-on group occurs on a set schedule so that it is known when to invoice the sponsor. The as-incurred group events can happen any time. As a result, the study team has to let the billing team when a particular event happened. This can be completed in OnCore by the study team using the “CRA trigger” to create the invoiceable item.
The Standard Protocol Related events matrix with only a few events for illustrative purposes looks like:
View the entire list (and definitions)