In STUDY > STUDY PROFILE Section 6 Subject Visit Schedule within the "Manage Subject Visit Schedule" gris there are three columns at the right edge of the rows.
These three columns are only used in certain circumstances when an EDC integration is being used for the study. If EDC integration is not setup for the study, then no entries are to be made in these columns.
The Subject Event column is only used in those cases where the EDC integration is unable to obtain a subject status from the EDC database; that is, the STUDY > STUDY PROFILE Section 10 Integration Settings Subject Status Mapping table would either be incomplete or completely blank. In those cases, the following rules are to be followed:
- Enter only one subject status in a row
- If more than one subject status is used in the subject visit schedule, there is no need to re-enter the prior subject status for visits taking place in between the subject status changes
- Enter the subject status on the first visit where that particular subject status can occur
See the following example:
Notice that the Screening and Enrolled – On Study subject statuses are entered on the rows where these statuses apply. Also notice that from the baseline visit to the end of study visit, the Enrolled – On Study subject status is not entered on the visit rows in between. And lastly, the end of study visit applies the Enrolled – Off Study/Completed subject status.
The EDC Visit Name column is used on those occasions where the names of the visits in the Visit Name column (all the way to the left) do not match how the visits are identified in EDC. Typically, the entries in the Visit Name column are more representative of how the visits are named in the protocol. In the EDC Visit Name column, for each appropriate visit row, the name of the visit as found in the EDC system would be entered. This way, SimpleTrials can communicate with the EDC system and match the visits accordingly.
The EDC Visit Date ID column is used on those occasions where the ID for the visit date differs from a default value that has been entered in STUDY > STUDY PROFILE Section 10 Integration Settings. An entry for each visit where this applies allows SimpleTrials to receive the actual visit date for that visit from the EDC system.
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