ARGUS Query Process Overview_Katalyst HLS
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Transcript of ARGUS Query Process Overview_Katalyst HLS
ARGUS Query Process Overview
12-24-2016Katalyst Healthcares & Life Sciences
1
Query OverviewQueries 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 itemDo 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
12-24-2016Katalyst Healthcares & Life Sciences
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
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
12-24-2016Katalyst Healthcares & Life Sciences
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
12-24-2016Katalyst Healthcares & Life Sciences
Generate Query Letter cont…
Once the query letter is attached, the ‘date’ will auto-populateCode: 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 siteQuery letter is viewed by clicking on the envelope beside the
date sent fieldOnce 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)’
12-24-2016Katalyst Healthcares & Life Sciences
Screen Shots
Contact Log query letter
Action Item ‘Query Letter’
12-24-2016Katalyst Healthcares & Life Sciences
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
12-24-2016Katalyst Healthcares & Life Sciences
‘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)
12-24-2016Katalyst Healthcares & Life Sciences
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
12-24-2016Katalyst Healthcares & Life Sciences