DF_PTunexpected — List unexpected data records found in the study database
DF_PTunexpected
{study}
[
[-i #, #-#]
| [-c #, #-#]
]
[-v #, #-#]
[-p #, #-#]
This report lists unexpected plates and visits found in the study database by DF_QCupdate. The report output appears as illustrated in the following example.
DF_PTunexpected: Unexpected Data by Subject. DFstudy 2. Jan 25,2016 12:08
99010 Visit 1019: Phase I: 1-Mon, Extra Visit 9
Plate(s) : 24,30-33,35-36
Problem : unexpected visit: 18 days post termination
99011 Visit 1020: Phase I: 2-Mon Visit
Plate(s) : 30-34
Problem : unexpected plate: excluded by plate condition 24
99011 Visit 1020: Phase I: 2-Mon Visit
Plate(s) : 75
Problem : unexpected plate: not required, optional or conditional
99011 Visit 1021: Phase I: 2-Mon, Extra Visit 1
Plate(s) : 20,24,30-36
Problem : unexpected visit: excluded by visit condition 5
The output for each problem consists of 3 lines. The 1st line identifies the subject ID, visit number and visit label. The 2nd line identifies the plate or plates that were unexpected at that visit. The 3rd line describes the problem as follows:
unexpected plate: excluded by plate condition #. This problem description identifies plates that have been received unexpectedly because they were excluded by one of the conditions specified in the conditional plate map. Use DF_SSvisitmap to get a numbered list of the conditions in each conditional map.
unexpected plate: not required, optional or conditional. This identifies plates that have been received for a visit which are not defined as required or optional in the visit map and have not been triggered by a conditional plate map specification. If such plates are allowed, and perhaps optional, they should be included in the visit map specification for each visit at which they might be used.
unexpected plate: a missed visit plate exists for this visit. A missed visit plate can be defined in the visit map for each visit. Typically a missed visit plate corresponds to a one page CRF form which is submitted by the clinical sites to give notice that a required subject assessment can not be completed because the subject missed the visit, refused the assessment, became ineligible for the assessment, etc. It is thus inconsistent for the site to submit a missed visit form and also to submit one or more plates for the same visit.
unexpected visit: # days post termination. If a termination event has occurred within a cycle we do not expect any visits to be performed within that cycle following the termination date. And if an abort event has occurred we do not expect any visits to be performed after the abort date in any of the study cycles. DF_PTvisits can be used to list all visits completed for a subject and to identify those visits at which a termination event occurred.
unexpected visit: excluded by visit condition #. This problem description identifies visits that have been received unexpectedly because they were excluded by one of the conditions specified in the conditional visit map. Use DF_SSvisitmap to get a numbered list of the conditions in each conditional map.
unexpected visit: excluded by cycle condition #. This problem description identifies visits that have been received unexpectedly because they were excluded by one of the conditions specified in the conditional cycle map. Use DF_SSvisitmap to get a numbered list of the conditions in each conditional map.
unexpected visit: aborted in prior cycle. If an abort event has occurred we do not expect any visits to be performed after the abort date in any of the study cycles. DF_PTvisits can be used to list all visits completed for a subject and to identify those visits at which a termination event occurred.
If no options are specified DF_PTunexpected lists all of the unexpected records identified by the last execution of DF_QCupdate. The following options can be used to focus the output on selected cases.
-i | select subjects by ID |
-c | select subjects by site ID |
-v | select problems by visit number |
-p | select problems by plate number |
The input for DF_PTunexpected comes from DFdiscover retrieval file
DFunexpected.drf (created by DF_QCupdate).
Thus, the output will include unexpected data records identified by the most recent
execution of DF_QCupdate, and will not contain any changes that have occurred since then.
Cycle, visit and plate requirements are not fixed and may change during the trial.
For example, a plate may be unexpected because the data value that makes it required
has not yet been entered into the database, or has been entered incorrectly.
It is thus necessary to manually review these cases before generating data queries
for the clinical sites. The best way to accomplish
this is to use DF_PTunexpected to produce a
list of the current problems, and then use DFunexpected.drf
to retrieve and review
these cases in DFexplore Data View, where data entry errors can be corrected and
queries can be created as needed.