Deleting a site and un-assigning patient from site that needs to be deleted. (Doc ID 783457.1)

Last updated on NOVEMBER 28, 2022

Applies to:

Symptoms

Here is an example:

30701 (right patient position) is assigned to study site 033_1683 (wrong), site 033_1683 (wrong), investigator 307_1725 by mistake.

The correct assignment should be study site 307_1725, site 307_1725, investigator 307_1725 according to US convention.

Lab data and CRF data have been loaded and entered before the mistake is found.

Key change is done on all CRF data for this subject so site is changed from 033_1683 to 307_1725.

Hard delete is performed on all lab data for this subject.

When trying to un-click 30701 from study site 033_1683 so that you can eventually delete study site 033_1683. However, you get "Received DCIs exist, unassignment not allowed" even when you cannot find any RDCIs for this subject.

Created study site 307_1725 and assign investigator 307_1725 and link 30701 to the correct study site. The position is successfully linked. This new assignment seems to make 30701 automatically un-assign from study site 033_1683. The data views show that subject has site as 307_1725.

Now the patient is assigned to the correct site. The next step is to delete study site 033_1683 from the study. This does not succeed.

When you try to delete 307_1725 from the Investigator Assignment window, the error says "Deletion not allowed Received data exist".
When you put a termination date and tried to delete from the same window, the error says "Only current record can be deleted".
When you try to delete 033_1683 from study site window, the error says "study site role exists"
When you try to delete 033_1683 from study site relationship window, the error says "delete in this context not allowed".

Changes

Cause

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.