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'Significant FU' Row Created By EOSU Does Not Display In Previous Versions (Doc ID 2660297.1)

Last updated on MAY 04, 2020

Applies to:

Oracle Argus Safety - Version 8.2 and later
Information in this document applies to any platform.

Symptoms

'Significant FU' row created by EOSU does not display in Previous Versions.

 

Current version of case correctly displays FU #5 – created by EOSU

 

 

Latest previous version – 194

 

 

Open v194 – FU does not display

 



The system creates a row in the database and Audit Log, but when viewing previous version (after EOSU) the 'Significant FU' is not displayed.


Following are the steps taken to replicate the issue:

Internal test instance: <test instance>

1) Create new study


Study Id = JMStudy001
Project Id = JM Project
Observe Study Type (ICSR) = Clinical Trial
Study Name = JMStudySingleBlind
Study Type = Single Blinded
Primary License = null
Products
Paracetamol, Blinded = Y
AMOXEN, Blinded = Y
CARBOPLATIN, Blinded = Y
Study is eligible for Unblinding = Y

JMStudy001 appears in drop down for Utilities > End of Study => OK

2) Create case US20200400616 in study JMStudy001

Initial Receipt Date = 01-apr-2020
Central Receipt Date = null
Study Information > Study Type = Single Blinded
Blinding Status = Blinded
Products
Product Name = JMStudySingleBlind
Drug Code = null and greyed out
No field 'Study Drug'

3) Lock case


4) Unlock case and add significant follow-ups


FU     Received  Safety Received
--      --------- ---------------
f/u#1 02-APR-20 02-APR-20 lock, unlock
f/u#2 03-APR-20 03-APR-20 lock, unlock
f/u#3 11-APR-20 11-APR-20 lock, unlock
f/u#4 11-APR-20 15-APR-20 lock

5) View case - all follow-ups displayed in this order:


# FU Received     Safety Received
-      ----------- ---------------
3     11-APR-20   11-APR-20
4     11-APR-20   15-APR-20
2     03-APR-20   03-APR-20
1     02-APR-20   02-APR-20

Case has 16 revisions
Follow-ups were added in revs 5,8,11,14

6) Open rev 15 - all follow-ups displayed in same order as above


=> OK

7) Unlock case and add Sponsor Identifier = Pat. ID = Randomization # = 123


8) Lock case


9) Close case

10) Use Web server, End of Study Unblinding tool

11) Log in as <username> (member of End of Study Unblinding group)

12) EOSU > Configure EOSU

New EOSU
Profile Name = JMStudy001
Study Definition
Study Number = JMStudy001
Include Cases = All
Schedule Expedited Reports = None
Pending Workflow State = Go - PeerReview
Closed Workflow State = Closed
Case Narrative Text = Case unblinded due to end of study
Patient Randomization Data
Data File = C:\users\<username>\RND16.xlsx
STUDY NUM = JMStudy001
COUNTRY = UNITED STATES
CENTRE = null
PRN = 123
Treatment Code = A
Patient ID = 123
Load Data -- Number of Rows loaded = 1
Validate data -- no rows with invalid data
Product Mapping
Treatment Code = A
Study Product = AMOXEN
Dosage
Available Items = automatically populated with A - AMOXEN
Dosage Options = No change to dosages

Profile Name = JMStudy001 no longer has an asterisk => complete

13) EOSU > Execute EOSU


Profile Name = JMStudy001
Run
EOSU Execution Options
Unblinded Report = Y
EOSU Process = N
Mode = Dry Run
Exception Report = N
Advanced = (None)
Click on OK

End of Study Unblinding Profile JMStudy001 (JMStudy001) executed successfully.

14) EOSU > Report Viewer


Select JMStudy001 (JMStudy001), then Unblinded Report
contains case US20200400616


=> OK

15) EOSU > Execute EOSU


Profile Name = JMStudy001
Run
EOSU Execution Options
Unblinded Report = Y
EOSU Process = Y
Mode = Update
Exception Report = Y
Advanced = (None)
Click on OK

End of Study Unblinding Profile JMStudy001 (JMStudy001) executed successfully.

16) EOSU > Report Viewer


Select JMStudy001 (JMStudy001)
Exception Report contains no records
EOSU Process Log contains
Processing Case US20200400616
Attempting to break blind for case US20200400616 and study num JMStudy001
Processing case US20200400616 in StudySpecificPkg.


BLIND BROKEN: Case US20200400616, Study Product Count for this Case = 1, Administered Drug(s) are
(1) AMOXEN


Successfully processed case US20200400616

17) Open case


Case is still locked, State = Closed

A new follow-up was automatically created
follow-ups displayed in this order

# FU Received Safety Received
- ----------- ---------------
1 16-APR-20  16-APR-20 <------ today's date
4 11-APR-20  11-APR-20
5 11-APR-20  15-APR-20
3 03-APR-20  03-APR-20
2 02-APR-20  02-APR-20

General tab > Study Information, Blinding Status = Broken After Study
Products tab > Product Name = JMStudySingleBlind
Products tab > Study Drug = Amoxen

Case now has 21 revisions

Open revision 21
Only 4 follow-ups are displayed

# FU Received Safety Received
- ----------- ---------------
3 11-APR-20  11-APR-20
4 11-APR-20  15-APR-20
2 03-APR-20  03-APR-20
1 02-APR-20  02-APR-20


the unblinding revision is not displayed

=> reproduced as described

US20200400616 (case_id = 101104)

select SEQ_NUM, RECEIPT_DATE, SAFETY_DATE, SIGNIFICANT, AUDITLOG_TYPE
from CASE_FOLLOWUP
where CASE_ID = 101104

 

SEQ_NUM RECEIPT_DATE SAFETY_DATE SIG AUDITLOG_TYPE
-------    ------------    -----------    --- -------------
100386    02-APR-20       02-APR-20     1    5
100387    03-APR-20       03-APR-20     1    8
100388    11-APR-20       11-APR-20     1   11
100389    11-APR-20       15-APR-20     1   14
100390    16-APR-20       16-APR-20     1

 

Cause

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In this Document
Symptoms
Cause
Solution
References


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