Prior to Creating Events

Prior to creating events, users will need to ensure that their required documents are set up appropriately. It is recommended to make any required changes in the room’s Configuration Manual and to work with the Trial Interactive Service Desk to ensure that all changes are made correctly. For more advanced users, please see the section about updating required documents for instructions on how to adjust these requirements.

Users will have the choice to indicate whether a document type is to be required “Immediately” or upon “Event Completion.” A placeholder will be created automatically for any document which is indicated as being required immediately. Documents which are intended to be associated with events will not necessarily be due right away and, in order to allow users to get a better sense of the current state of the eTMF, placeholders for these documents will not be generated until the associated event has been created and placed into a status of “Completed.” Once the event is marked as completed, the placeholders will be visible in the room at large and will impact eTMF completeness, but not before then.