The Data in EDC Doesn't Match the Data in SimpleTrials

When a study has EDC integration enabled, the data in SimpleTrials for subjects, subject visit dates, visit status, and subject status among other data points are updated on a nightly basis. The general thought to keep in mind, is that if there is data for a field in EDC that is included in the EDC integration, that same data will be transferred to SimpleTrials.

With the above in mind, there are two likely scenarios for why there might be a mismatch in actual visit dates between EDC and SimpleTrials.

Scenario 1:

In this scenario, site personnel may have entered data for a visit in EDC that was later corrected. As an example, if a site completes the forms associated with an Early Termination visit by mistake, and later corrects the error by deleting all of the data in EDC for that visit, SimpleTrials will continue to retain the actual visit date along with any other associated data for that visit (in this case, perhaps the subject status was also changed to Enrolled - Discontinued).

In order to "fix" this mismatch in this scenario, a user who has full access to the SUBJECTS > SUBJECT VISITS view would find the subject visit in question and delete the actual visit date and any other data completed in this view by the EDC integration. If the subject status was changed, then a user with full access to the SUBJECTS > SCREENING & ENROLLMENT would navigate there and update the subject status to the correct one.

Scenario 2:

In this scenario, the EDC integration was implemented after the study had started and there were subjects already manually entered on the SUBJECTS > SCREENING & ENROLLMENT view. As stated earlier, if the data is present in EDC and is part of the EDC integration, SimpleTrials will be updated accordingly.  In the case where there might be manually entered data that is not present in EDC and that data is not appropriate, a similar set of steps as in Scenario 1 would be followed. If one or more subjects do not belong at all, then a user with full access to the SUBJECTS > SCREENING & ENROLLMENT view could simply delete the subject from the view by clicking on the "(-)" button.

If the mismatch was limited to an incorrect subject visit, then a user with full access to the SUBJECTS > SUBJECT VISITS view would find the subject visit in question and delete the actual visit date and any other data completed in this view.