22nd Sep 2014, 06:49 AM
Deleted records by site in error
If a site personnel has misunderstood instructions and deleted data from the eCRF and the PI
is refusing to enter the data, what process should be in place to ensure we are in compliance With ICH GCP.
23rd Oct 2014, 08:27 AM
I was wondering if anyone can help in this matter.
Originally Posted by blsm002
17th Nov 2014, 07:35 AM
why the PI is refusing to do this?If the data is available in the SDs and should be entered in the eCRF you need to have some explanation why the data was deleted? If in error why then the PI is erfusing to do it now? You need to have this also explained in CRA monitoring reports or in a sperate document (note to file). It is also good to review the site personel trainings ion eCRF completion, to avoid this in future and if needed to document some re-training on this matter.
The main point is to clear what are the reasons for refusing entering data..