DCM Tracking Tools
Oracle Clinical provides reports and forms that interact dynamically with the schedule established during study design. This study schedule creates the framework within which visits and their associated DCMs are expected; when DCMs are missing or overdue or have discrepancies associated with them, they are reported in various levels of detail by the tools listed in the following table.
Table 3-3 Tools for Tracking Missing Data
| Feature | Purpose | Menu Path |
|---|---|---|
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Allows queries for missing or missing and overdue DCMs. Optionally mark them as "not expected", then enter comments. Events marked "not expected" are not reported as missing. |
From Data Entry menu, select Missing DCMs |
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Provides detailed scheduling, data entry, and validation status for DCMs. Reports associated discrepancies of up to three review statuses. Responds dynamically to events such as early termination and nonexpected visits. Projects future visits. |
From Data Entry menu, select Data Entry Reports, and then DCM Detail Tracking Matrix |
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|
Identifies missing DCMs per study, Investigator, patient, and visit. |
From Data Entry menu, select Data Entry Reports, and then Missing and Overdue DCMs |
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Summary section listing patients whose data has outstanding problems; identifies RDCMs with missing pages. |
From Conduct menu, select Conduct Reports, then select Data Validation, and then Investigator Corrections and Missing Pages |
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