Secondary outcome measures must be submitted to ClinicalTrials.gov within a year of completing data collection for each outcome measure per the Final Rule (42 CFR Part 11). While TrialScope Disclose has standard rules which automatically create compliance events disclosing results after the primary completion and study completion dates, secondary outcome disclosure is more complicated because there is no standard way that our customers are collecting these dates.
Because there is not a standardized way that our customers track when their secondary outcome measures have completed data collection, we do not have a rule to automatically create a compliance event to track disclosure for it. We have discussed and investigated options with our customers and have concluded that a manual compliance event is the best option to meet the need at this time and this option is already available to you!
You can create a manual compliance event to meet a compliance obligation that are not automatically created, such as for tracking the need to disclose secondary outcome measures. You will find instructions on how to create a manual compliance event below.
In addition, a "Disclosing Secondary Outcome Measures Report" is coming soon to show the studies that may need a manual result maintenance event.
Adding a Manual Compliance Event
Users may add a manual, or user-initiated, maintenance event to manage the work and timelines. This can be created after the Initial Results Disclosure compliance event is completed.
Locate to the study wish to add a Compliance Event. Check out the study for editing. Navigate to Compliance. Click Add
Populate the required fields on the Add Compliance Event popup. Click Save.
Observe Compliance event has been created and is displayed in the list of Compliance Events associated with the Compliance Authority. Manually created compliance events have a different icon to identify that the event was created manually.