As I dig into OC from data perspective I have more questions, I appreciate your continuous help...
First, SDVs, the event_crf table is our guy, the sdv_status column informs us if a given SDV has been completed/verified, and the sdv_update_id provides info of who does it. Question, how do we know WHEN this SDV has been updated or otherwise been acted upon? The data_updated column does not seem to capture such data (I tried it). Also, do you usually have a rule that dictates that prior to a SDV verification "electronic signature status" must be set to "true"/"complete" (existed already)?
About AEs and SAEs
1) how many AEs and SAEs are considered too many during the course of a trial/study?
What's your threshold of AEs or SAEs to stop the trial all together? Is such info available from the protocol?
2) how do we translate subject_event_status_id column for the study_event table to semantic?
That is, what exactly does it mean and its implication?
I understand if I were a CRA or CRC (and some other roles), the OC portal provides a menu item of "Subject Matrix", under this tab, such user may take certain actions... where are the data stored for such actions, namely, what tables? It seems Study_Event, EVENT_CRF are the logical ones... any more?