How Does Oracle Clinical (OC) Track DCMs Using The Enrollment Date? (Doc ID 329696.1)

Last updated on JANUARY 13, 2009

Applies to:

Oracle Clinical - Version: 4.5
This problem can occur on any platform.

Symptoms

The DCM Detail Tracking Matrix for Study Report is not functioning as documented in:

Oracle Clinical
Conducting a Study
Release 4.5
Part No. A85201-03

According to this documentation (pp 3-2 and 3-3) the system goes through three steps to project the visit date. The third step is described as follows:

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

In other words, for a patient enrolled in Jun-2001 you expect to see visit dates calculated. The following example should spawn this behavior.


Steps required to reproduce the problem:

Create events:
1. Baseline 1 -visno 1 - days from start of study: 1-1
2. Baseline 2 -visno 2 -optional-days from start of study: 8-15
3. Visit 1 -visno 3 -optional - early term. days from start of study: 29-36
4. Visit 2 -visno 4- days from start of study: 50-57
5. teRmination -visno 5 -normal term-days from start of study: 64-71
6. Follow up -visno 6-days from start of study: 85-99
7. Enroll a patient with enrollment date 14-jun-2001.
8. In the DCM detail tracking matrix this patient is not visible.


You expected OC to identify all DCMs as missing for that patient. But it does not identify any missing DCMs at all. In summary: How does this third search method work when you track DCMs? Upon using DCM Tracking Matrix report to identify the received and non received DCM statuses nothing is printed out for this patient.



Cause

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