DF_CTqcs

DF_CTqcs — Summary report of external queries for each site

Synopsis

DF_CTqcs {study} [-x] [-a] [-v] [-c #, #-#] [-P #, #-#] [-S #, #-#]
[ [-t yy/mm/dd] | [-t ] | [-t yy/mm/dd-yy/mm/dd] | [-t ] ]

Description

DF_CTqcs reports a summary of the user-created, external queries added during data validation. queries are selected by their creation date from a specified time period that may include one of:

  • from the beginning of the study
  • from a specified date
  • between two specified dates

The following queries are not included in the report:

  • Internal queries
  • Missing page queries (added by DF_QCupdate or edit checks),
  • Overdue visit queries (added by DF_QCupdate)

The summary is in the form of two tabular reports. The first report displays for each site (row), columns that contain:

        TOTAL    TOTAL    RATE/  RESOLVED QRYS  STATUS & TIME TO RESOLUTION
  SITE  RECORDS  QRYS    100 REC    #     %     Correct   N.A.   Irrel.  DAYS  Pending
        (1)      (2)     (3)      (4)            (5)                      (6)   (7)

(1)

Number of primary records created

(2)

Number of external queries created during validation

(3)

Query rate = number of queries created per 100 primary records created

(4)

Number and percentage of these queries which have been resolved

(5)

Number of each resolution type from the list:

  • corrected
  • not available
  • irrelevant

(6)

Mean time (in days) from the creation of the queries to their resolution

(7)

Number of queries that have replies that are pending review

The second table displays for each site (row), columns that contain:

           AGE (DAYS) NEW/UNSENT QUERIES(1)   AGE (DAYS) SENT/UNRESOLVED QUERIES(2)
  SITE    00-10  11-20  21-30  31-60  > 60     00-10  11-20  21-30  31-60  > 60

(1)

Categorical time (in days) from query creation to today's date, for unresolved queries that have not been sent to the sites in a Query Report.

(2)

Categorical time (in days) from query creation to today's date, for unresolved queries that have been sent to the clinical sites. Queries with status pending are included in this category.

An alternative report format can be requested with -a. This report format is a single table that is a hybrid of the two, already described, tables. Rather than displaying the status of resolved queries from the first table, the hybrid report displays the age of unresolved queries from the second table, so that the column headings read:

        TOTAL    TOTAL   RATE/   RESOLVED QRYS  AGE (DAYS) OF UNRESOLVED QRYS
  SITE  RECORDS  QRYS   100 REC     #     %     <=10 11-20 21-30 31-60   >60

DF_CTqcs uses summary file which is created by DF_XXtime. DF_CTqcs checks the summary file DFX_time1 against the study database and sites database to see if either database has changed since the file was last created. If either or both databases have changed, DF_XXtime is executed to rebuild DFX_time1, otherwise this step is skipped. If DF_CTqcs is run with the option -x, the results will reflect the state of the database on the last time that DF_XXtime was run.

If subject IDs exist in the database which do not correspond to any of the sites in the sites database, they are assigned to the ERROR MONITOR. By default, DF_CTqcs includes such subjects when making this report. If -v (for verbose mode) is used, such cases will be listed at the end of the report.

[Note]Note

The count of primary records and queries created during the specified time period are not necessarily related, as some or all of the selected queries may have been added to previously created records (which would not be selected). Thus this report may reflect both coordinating site activity as well as site performance. An increase in querying by data staff could make it appear that CRF problems are rising when it is really just an increase in the search for problems. Also an increased focus on some sites could make the quality of CRFs arriving from those sites appear worse than that from sites under less scrutiny. However under most circumstances the relative number of queries and primary records created during the specified time period should generally reflect the quality of the original CRFs being received from each site.

Options

-a

Show age of unresolved queries (instead of query status).

-v

Verbose. Subject IDs not belonging to any site are reported at the end of the report.

-c #, #-#

Include only the specified site IDs.

-P #, #-#

Include only the specified plates.

-S #, #-#

Include only the specified sequence or visit numbers.

-t yy/mm/dd, -t

Include records and queries created since specified date, inclusive of the specified date

-t yy/mm/dd-yy/mm/dd, -t

Include records and queries created between specified dates, inclusively

Limitations

  1. This report cannot be used to obtain the status of internal queries or external queries created for missing pages and overdue visits.

  2. Mean days from creation to resolution is based on those queries that have been resolved so far and thus may not reflect the true average time if there are many unresolved queries of long duration.

See Also

DF_XXtime
DF_PTqcs