3 Tracking DCMs

3.2.1 The Study Schedule

Oracle Clinical forecasts expected data from the study schedule. The study schedule is created during the following activities:

• During study design, you establish the number of Clinical Planned Events (CPEs, usually patient visits), and the intervals between them. When you set up the CPE schedule, you enter offsets between visits or offsets from the beginning of an interval to indicate when visits should take place. (See Oracle Clinical Creating a Study for more information.)

• During study data definition, after you have created DCMs and DCM subsets, you define them as Expected or Optional against the CPEs in the DCM Schedule window. In other words, DCMs are created and then mapped to the visit schedule. (See Oracle Clinical Creating a Study for more information.)

Putting together the CPE schedule, DCMs and DCM subsets, DCM schedule, and the data that has actually been received, Oracle Clinical determines visit dates (actual or scheduled), projects expected DCMs, and identifies missing DCMs.

Oracle Clinical uses the date of the first received DCM as the actual visit date, and calculates the scheduled visit date from the following algorithm:

1. Oracle Clinical searches to find the earliest, non-null DCM date for scheduled DCMs received for the most recent planned visit with a visit number less than or equal to the missing DCM's expected visit number. If it finds such a non-null date, Oracle Clinical uses that date and visit number with the schedule of events to project the missing DCM's expected visit date.

2. If the first search fails, Oracle Clinical performs a broader search to find the earliest planned visit for which a scheduled or termination DCM with a non-null DCM date has been received. The date and visit number are used with the schedule of events to project back to the missing DCM's expected visit date.

3. If the first two searches fail, Oracle Clinical bases the schedule of events on the patient enrollment date, and projects forward the expected visit dates for missing DCMs.

3.2.2 How Optional Visits Interact with DCM Tracking

Making a visit optional, as in the case of the baseline 2 and early termination visits in Table 3-1, tells the system to not report a problem if no DCMs are entered for the optional visit. However, if one or more DCMs is entered for an optional visit and other expected DCMs are not, the other DCMs become relevant and Oracle Clinical reports them as Missing.

Early termination visits are considered optional by default; normal termination visits are not optional and are handled as routine.

Table 3-1 is an example of a typical clinical study schedule that shows the planned receipt of expected (E) and optional (O) DCMs over eight visits.

Table 3-1 shows that the projected visit schedule includes:

• Two baseline visits, one of which is optional

• Three routine visits (Visits 1, 2, and 3)

• A normal termination visit

• An early termination visit, which is optional

• A follow-up visit

Also in Table 3-1, three DCMs are in the study schedule:

• DCM1

• DCM2

• TDCM (Termination DCM)

3.2.3 How Termination Visits Interact With DCM Tracking

If a patient withdraws from a study earlier than expected, visits scheduled after the date of early termination—that is, where dates and visit numbers are greater than the early termination visit's—are no longer expected. You can indicate that early termination has occurred in two ways:

• Create an early termination visit. Any DCM logged in at that visit signals that early termination has occurred.

• Create a DCM of type termination. When this DCM is logged in at any visit, that visit is considered to be the early termination visit.

Table 3-2 explains how early and normal termination visits affect DCM tracking.

3.3.1 Maintain Missing DCMs Window

Use this window to query for missing DCMs and to mark them as Not Expected if appropriate.

Some DCMs marked as Missing may actually not be expected for that particular patient or visit. To prevent Oracle Clinical's giving a DCM a Missing status when it was not expected, mark it Not Expected in the Maintain Missing DCMs window, and add a comment about why you made the change.

You reach this window by selecting Missing DCMs from the Data Entry menu. Follow these steps:

1. Query for missing DCMs.

   Oracle Clinical displays missing DCMs by patient number and then visit number. Scroll to the missing DCM subset you want.

2. Scroll to the right.

3. Uncheck the Expected? box if the DCM is not expected, and add optional comment text.

   Notes:

   • You can check a DCM to make it Expected even if you had previously marked it as Unexpected.

   • You cannot update missing DCM information for frozen patient positions.

See information on other DCM Tracking Tools.

3.3.2 DCM Detail Tracking Matrix Report

The DCM Detail Tracking Matrix report shows a detailed summary of DCM activities for one or more patients. See Example 3-1, "DCM Detail Tracking Matrix Report" for a sample copy of the report, followed by an explanation of the information contained in the report.

To print this report, from the Data Entry menu, select Data Entry Reports, then select DCM Detail Tracking Matrix. See "Report Parameters".

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DEMOG

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01-JAN-2000p. 10

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 A567
31-MAR-96
p. 13

VTLS

VITALS

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01-JAN-2000p. 10

DAL

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LOCK DIS
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10-APR-96
P. 20

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01-JAN-96
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06-JUL-96

DeviationFoot 1  (Days)

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DurationFoot 2  (Days)

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Interval (Days):

SchdFoot 3  (Min/Max)

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3.3.3 Missing and Overdue DCMs Report

To submit this report, from the Data Entry menu, select Data Entry Reports, then select Missing and Overdue DCMs.

This report provides the following information about missing and overdue DCMs for the parameters you select, organized by patient:

• visit at which the DCM was expected to be collected

• whether the DCM is missing or overdue

• date of the visit, and whether the visit occurred (Actual; other DCMs were collected) or was only Scheduled (no other DCMs have been entered for the visit)

• the number of days overdue

• short name of the DCM and subset

• missing DCM page(s)

To run this report, enter the following parameters:

• Investigator. Choose one from the list of values or leave the wildcard (%) default to see results for all Investigators in this study.

• Site. Choose one from the list of values or leave the wildcard (%) default to see results for all sites in this study.

• Patient. Choose one from the list of values or leave the wildcard (%) default to see results for all patients in this study.

• DCM Name. Choose one from the list of values or leave the wildcard (%) default to see results for all DCMs in this study.

• Missing DCM Status. Choose one from the list of values or leave the wildcard (%) default to see results for all missing DCM statuses in this study. The abbreviations used for the list of values here are: M for Missing, O for Overdue, MO for Missing and Overdue, OT for Off Target, and MT for Missing and Off Target. See Table 3-8, "Statuses for DCMs Not Received" for further information on the meaning of these statuses.

• Start Date. The first date for which you want to see response data.

• End Date. The last date for which you want to see response data. If blank, the system uses the current date.

• Target Receipt Days Off Schedule. The number of days that the DCM is overdue. You can use this parameter to report DCMs that are exactly a certain number of days overdue.

3.3.4 Investigator Corrections and Missing Pages Report

To submit this report, from the Conduct menu, select Conduct Reports, then select Data Validation, and then Investigator Corrections and Missing Pages.

This report provides the following information about missing pages for the parameters you select, organized by patient:

• First a summary, giving, for each patient:

  • first visit number and date of first visit

  • latest visit number and date of latest visit

  • next planned visit number and date

  • status

• Second, a detailed section organized by patient and visit, with information for each RDCM with a problem:

  • number and date of visit when problem occurred

  • whether the visit was Actual (other DCMs were collected) or Scheduled (other DCMs were not collected)

  • the nature of the problem (for example, missing pages)

To run this report, enter the following parameters:

• Investigator. Choose an Investigator from the list of values.

• Patient. Choose one from the list of values or leave the wildcard (%) default to see results for all patients in this study.

• DCM Name. Choose one from the list of values or leave the wildcard (%) default to see results for all DCMs in this study.

• Modified Since.

• Modified Until.

• Summary Reporting Inclusion Flag.

• Discrepancy Reporting Inclusion Flag.

• Missing Pages Reporting Inclusion Flag.

• Company Name.