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


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


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


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)’


Screen Shots

Contact Log query letter

Action Item ‘Query Letter’


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


‘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)


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


Health & Medicine

ARGUS Query Process Overview_Katalyst HLS