Responses Get Deleted After Raising The Manual Discrepancy
(Doc ID 2158941.1)
Last updated on FEBRUARY 10, 2022
Applies to:Oracle Clinical - Version 5.0.1 to 5.0.1 [Release 5.0]
Information in this document applies to any platform.
1. A DCI is defined with a repeating Question Group, having 5 questions and 5 repeats.
3 of the 5 questions were hidden in the layout and moved to a corner of the page.
(Questions are 'hidden' by shrinking the fields to mere pixels, deleting their labels and overlapping them one with another.
A cryptic text label is placed on top of the whole overlapping set of invisible fields, presumably providing a 'handle¿ by which the fields can be dragged to other positions in the layout.)
The hidden questions have repeating defaults.
2. In RDC, patient data is entered for a CRF based on this DCI/layout and saved. In conjunction with the Save, repeating defaults are saved to the database for the hidden questions.
3. The DCI layout was modified to create a Conditional Block whose target question is in a separate, non-repeating question group.
At the same time, the group of hidden repeating questions was unintentionally moved to the conditional block.
**(Refer to BUG 23524852 , below wherein the Layout Editor allows the conditional block to contain only a subset of the repeating question group.)**
4. Upon re-opening the CRF using the new form version (with the DCI layout changes), RDC detects a conditional branch violation for the newly added conditional block,
meaning that response data has been detected in the disabled block of questions, whereas it should not have been possible to enter data via RDC.
RDC highlights this condition by shading the disabled block in grey, even though the ‘Represent Disabled Blocks as’ setting specifies 'Hidden’ not 'Greyed’.
Normally, this would allow the user visibility into the data constituting the violation. However, since the questions with data were hidden (doubly hidden),
it was not possible to see the data values violating the conditional branch logic.
5. Next, the user updates a response to the part of the repeating question group that is visibly displayed in the layout and performs a Save.
RESULT: Conditional Block handling treats a repeating group as one block. (Refer to Note 1 below).
Therefore, even though only part of the repeating question group is in the disabled conditional block, upon Save all responses for the repeating question group are deleted,
both the saved repeating defaults as well as the user-entered responses.
The deletion is recorded with a Data Change Reason of violation (Target responses deleted due to mismatch with conditional response)
6. In the second part of the scenario, the user re-opens the CRF, and no conditional branch violation exists because all responses have been deleted.
This time the user is able to successfully update and Save a response, seemingly without creating another branch violation. This is because the source value had not been changed.
[RDC performs the check for branch violations when the CRF is first opened and when the response to a source question is updated, indicating a block with previously entered data may have become newly disabled.
We expect that if the CRF were to be re-opened, a branch violation would again be detected.]
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