Generating, Tracking, Reviewing, and Resolving Queries Erik Jolles, Research Informatics, Family Health International

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1 Generating, Tracking, Reviewing, and Resolving Queries Erik Jolles,, Family Health International 1

2 Generating Queries Queries are reports that present potential data problems and propose resolutions to those problems. Queries can be created both automatically by computer programs and manually data managers filling out a form. 2

3 Examples of Automatically Generated Queries Missing item values Variations from an expected range Inconsistencies between values collected over time or entered into different database tables Missing or late CRFs Duplicate CRFs Missing dates. 3

4 Automatically Generated Query Example Automatically Generated Example of a missing item number 2a 4

5 Examples of Manually Generated Queries Missing Header Information Illegible Data Missing Pages Blank CRFs Invalid Patient Numbers Invalid Center Numbers Invalid Dates Form Sequence Numbers (FSN) that differ on multiple pages of the CRFs 5

6 Manually Generated Queries cont Unclear messages written in the body of the CRF by the site Information incorrectly crossed out on CRF Data that cannot be entered as shown on the CRF Items that have two written answers but only one is required Queries that were returned without a signature and date, or answered incorrectly at the site 6

7 Manual Query Example Manually generated Two written answers 7

8 Automatic Query vs Manual Query Automatic Manual Site manual query 8

9 Received Queries From Site When queries are received back from the site they are processed and date stamped. They are then forwarded to the Query Manager for resolution through the system. Each query has it s own unique Discrepancy Id number that is used to locate that discrepancy in the system. 9

10 Example of Received Queries Date Stamped 10

11 Tracking Queries All queries are tracked through the systems database regardless if they are automatic or manual queries. 11

12 Tracking Queries Each query has a unique identifier (number) Track the following information: Site query is sent to Date sent to site Date received from site Date query is resolved 12

13 Example of Tracking Queries Site query is sent to Date received from site Date sent to Site Date query is resolved 13

14 Reviewing Queries Reviewing is the process of comparing data on CRFs to data in the database If the problem reported on the query is valid, then the query will be sent to the site for resolution If the problem reported on the query is a result of a data entry error or another valid reason, then the query will not be sent to the site. 14

15 Reviewing Queries Before reviewing individual queries Confirm that the program that generated the queries worked correctly Review the frequency distribution of new queries If a new query was generated for each participant, perhaps there is a problem with the query specification or the program that generated the query 15

16 Report Examples Number of New (N) Queries Report: GSS_9726/ Frequency Distribution by All Query Status STATUS COUNT ACD 10 CU 2 N

17 Report Examples Frequency Distribution of New Queries Report: GSS_9726/ Frequency Distribution by Query Data Table Name Frequency FollowUp Report1 10 Report Final Report5 3 Report

18 Review Each Individual Query Determine if query is correct Are there handwritten notes on the CRF that will help resolve the query? Do multiple queries relate to one problem? 18

19 Multiple Queries (3) related to one problem 19

20 Resolving Queries Queries are resolved by updating the database and CRF with the given information recorded on the DPSF from the site. The CRF for that particular discrepancy is updated in red ink for the given item number, initialed by the Query Manager, and the current days date. 20

21 How FHI works with Remote Site Staff to Resolve Queries Created WDS- RDT (Remote Discrepancy Tool) RDT was developed to simplify the processing of sending and resolving queries RDT is used by both FHI query staff and remote site staff 21

RDT Query Processing Instead of sending queries via email to site

22 RDT Query Processing Instead of sending queries via to site staff, they are posted in RDT for the site staff to print and resolve. 22

23 RDT Query Processing Site staff print new queries, research and resolve them. Site staff use RDT to enter the query resolution and submit the response for review by the FHI query manager. 23

24 RDT Query Processing FHI staff review the query response. They can accept the response or request additional information from the site staff. If the query response is acceptable, the FHI staff enter the resolution into Clintrial Resolve and update the database. 24

25 RDT Query Processing Once a query response has been accepted, site staff print out completed query form then sign and date it. They file the query form according to their DM plan. 25

26 RDT Query Processing Reports There are 3 built-in PDF formatted reports: Summary Details DDF (actual Query form) 26

27 RDT Query Processing Reports 27

Case Report Form Design Erik Jolles, Research Informatics, Family Health International

Case Report Form Design Erik Jolles,, Family Health International 1 GCP Connection 1.11 Case Report Form A printed, optical, or electronic document designed to record all of the protocol required information