This document provides an overview of the query process in the Argus system. It describes how to enter individual query action items, generate query letters containing all open queries, follow up on query responses, and reissue query letters if responses are not received by the due date. The goal is to track queries and responses to allow useful metrics to be produced regarding open and closed queries.

1. ARGUS
Query Process Overview
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2. Query Overview
Queries are captured on the ‘Activities’ tab as individual ‘Action
Items’
Queries can be entered / revised during any step of case
processing
 E.g. Data Entry, QC, Medical Review
The individual query is to be entered as an individual action item
 Do NOT enter multiple queries in one action item
By following the steps in the following slides, useful metrics will be
able to be produced from Argus in regard to open queries
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3. Entering a Query Action Item
 Code: Select ‘Query Response Pending’
 Query Description: Enter the individual query (e.g. Please provide
outcome.)
** ‘Query response pending’ automatically populates but this should be removed
 Date Open: Will auto-populate as the current date when the code is
selected
** This date should correlate to the date the query was initially sent so if the action
item is generated on a different date than the date the query letter was sent,
the date will need to be revised.
 Date Due: Manually enter the date 2 weeks (or the query frequency in
the study specific SAE procedure) from the date open field
** This date should be 2 weeks from the date the query letter was sent to the site
 Group: Select ‘Data Entry: (DSAT, DSS, SDSS)’
** This will allow the team to easily identify action items for which they are
responsible

4. Query Action Item
 Add additional action items as required
 ‘Query response pending’ action items that have not been marked
as completed will be reviewed by the MD during the Medical
Review step
 The MD can revise, add, or delete queries
 Once the case is approved, the query letter can be generated
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5. Generate Query Letter
 On the activities tab, add a query letter under the contact log
 Click the ‘New Letter’ button
 Select the appropriate query letter template
 A template has been added for each region with the general
contact information in the header
 File download box appears. Select ‘Save’
 Save to your desktop or local drive and then open
 Edit query letter as required
 All action items with a code of ‘Query Response Pending’ and a
blank ‘Completed’ date will populate in the letter
 ‘Save Letter’ dialogue box: Click ‘Yes’ and attach the query letter
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6. Generate Query Letter cont…
Once the query letter is attached, the ‘date’ will auto-populate
Code: Select ‘Query’
Description: Auto-populated as ‘Query letter - send to investigator /
reporter’
Group: Select ‘Data Entry: (DSAT, DSS, SDSS)’
Date Sent: Enter the date the query letter was sent to the site
Query letter is viewed by clicking on the envelope beside the date
sent field
Once the query letter is generated, an action item with a code of
‘Query Letter’ is automatically generated
 Due date is auto-populated as 2 weeks from the date of query letter
generation
 Select the group ‘Data Entry: (DSAT, DSS, SDSS)’
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7. Screen Shots
 Contact Log query letter
 Action Item ‘Query Letter’
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8. Follow-Up Information Received
Mark the previous ‘Query Letter’ action item as completed by
entering the follow-up received date in the ‘Completed’ date field
For individual queries that have been answered, mark the ‘Query
response pending’ action item as completed by entering the follow-
up received date in the ‘Completed’ date field
If an individual ‘query response pending’ action item has not been
answered with the follow-up information, leave the ‘Completed’
date field blank
 This will allow for metrics to be run in regard to how long each query was
open prior to a response being received by the site
Enter new queries as required and follow previously described
process
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9. ‘Query Letter’ due date has expired
 If the ‘Query letter’ action item due date has expired:
 Close the action item by entering a ‘complete’ date
 At all times, there should be only one ‘query letter’ action item open
 Generate a new query letter under contact log
 The new query letter will contain all ‘query response pending’
action items that do not have a ‘complete date’ entered
 A new ‘query letter’ action item will be auto-populated with the
new due date
 Send the query letter to the site (MM review is not required since
no new queries were entered but instead the same queries are
being re-issued)
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10. Tips and Tricks
 The ‘Code’ in action items must say ‘Query response
pending’ for the queries (which are open) to appear on the
Query Letter
 You must save the case for the queries to appear on the
letter
 Be sure to assign Group so that action items can be easily
monitored
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