Key Change Of Site/Inv Doesn'T Cascade To The Dcf (Doc ID 1304022.1)

Last updated on JANUARY 30, 2025

Applies to:

Symptoms

ISSUE:
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After transferring a patient from a site to another site, the DCFs ( Data Clarification Forms) which include the Case Report Forms (CRFs) of the patient still display the old site and old investigator.

STEPS TO REPRODUCE:
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* Have a study with 2 sites.
* Enter data for a patient. Make the data entered creates a discrepancy.
* Go to Conduct > Data Validation > Data Clarification Forms, and create a DCF which includes the discrepancy created previously.
* In Oracle Clinical, navigate to Design, Patient Positions, Study Site Relations. A study selection window opens.
* Select the study of interest, then click the Sites button. The Maintain Study Site Relationships window opens displaying all of the sites related to the study.
* Select the site to which the patient is being transferred, then click the Patients button. The Link Patient Positions window opens.
* Check the Assign? checkbox for each patient you are reassigning.
* Save your work
* Navigate Conduct > Mass Change > RDCI Key Changes
* Create and execute a CDS which change RDCI.SITE from the old site to a new site
* Go to Conduct > Data Validation > Data Clarification Forms. The DCF still contains the old site and investigator.

BUSINESS IMPACT:
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The additional work would have to be to close the previously generated DCF and regenerate them post Transfer. This is an additional expense for the project.

Changes

Cause

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