Invalid Medical History Record Created If PATIENTEPISDODENAME [D.7.1.r.1b] Is Empty In E2B(R3) (Doc ID 2622736.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

An Invalid Medical History record is created if PATIENTEPISDODENAME [D.7.1.r.1b] is empty in E2B(R3)

Example:

It was noted that for a sample case, although all Parent Medical History records on the front end are coded, custom validation check "All terms on the Other Relevant History section must be encoded" was violated.

On investigation it was noted there existed an uncoded Medical History record in the database, which is not visible on the front end i.e. if open current case:

However, it is visible if a Revision is opened i.e.

Root cause is that a Medical History record was imported from E2B R3 XML which did not have a PATIENTEPISODENAME [D.7.1.r.1b], only Start Date and Continuing was provided per below:

Although it does not necessarily make sense to provide such data, this is allowed per ICH E2B(R3) implementation guide.

Argus stores patient medical history and parent medical history in the same database table, the column "parent" is the flag whether the data is for the patient (parent = 0) or for the parent (parent = 1).

This flag is set by the import logic of PATIENTEPISODENAME [D.7.1.r.1b]. However since that field is empty in the E2B, the flag is not set at all during import while the other data of the Medical History gets imported.

The invalid record in case_pat_hist table looks then like this (Run query on affected case as Argus Schema owner:

  

The empty "parent" column causes Medical History Record to not appear in the Argus front-end UI.

To get validation check resolved, the record needs to be updated via correction on the back-end. In this case parent needs to be updated / set with 0.

In order to avoid this issue in the future, the import logic of both patient and parent medical history requires a change to set the parent flag also if PATIENTEPISODENAME [D.7.1.r.1b] is empty, but other elements of the D.7.1.r block are imported.

Steps to Replicate

1. Import an R3 E2B XML file for OOTB EMA R3 profile Agency
2. File does not have a PATIENTEPISODENAME [D.7.1.r.1b], only Start Date and Continuing
3. Note the empty "parent" column causes that the Medical History Record to not appear in the frontend.

Changes

Cause

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