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Issue with Source Data Verification (SDV)
I don't know if this question has already been discussed, if yes please indicate me where i may find the discussion!
As I started using Open Clinica, I have been very upset by the fact, that there is no "SDV" button(s) on the pages.
This is a big issue I think...
It forces us to use other tools in order to record our SDV activity: this makes the work double and increases the possible sources of mistake...
I think one of the biggest target for Open Clinica are the Investigator Initiated Trials (IITs), and these trials often have very complicated, specific and reduced SDV plans (e.g.: every 10th patient has to be 100% SDVed, then only certain pages and certains values have to be SDVed for the other patients).
In this case, not being able to record precisely what has been SDVed or not, is a massive problem for the management of the study and potentially an important source of time loss and/or mistakes.
- MUST HAVE: an SDV tickbox for each and every element on the page
- MUST HAVE: a button to tick every tickbox on the page at once if needed
- MUST HAVE: tickboxes and button only accessible for Monitors (CRAs) and Project Managers (CPMs), visible for Data Management (DM) but not for site staff.
- NICE TO HAVE: a "monitoring comment field" on each page, only accessible to CRAs and CPMs, visible for DM but not for site Staff.
- NICE TO HAVE: being able to search SDVed elements/pages the same way as the queries can be searched
I hope this feedback will help improving the EDC!