Hi, I’m trying to get my head around a processes for validating data in a new study and I have a few of questions:
1) Do the CRF validations only fire when the form is saved during initial data entry, or do they also fire during administrative editing?
2) I understand that rules only fire during the initial save of a CRF. If that is the case how do you ensure that any corrected data is also correct?
3) If rules are run from the Rule Assignments screen do they generate discrepancies even if an open discrepancy already exists from a previous execution of the rule? What about if an earlier discrepancy provides an explanation for the failed data? Will a new discrepancy be raised under these circumstances?
Basically I need to understand how we ensure that corrected data is actually correct and that we don’t continually bug our sites with discrepancies for values that are legitimately out of range and which have been explained.
Has anyone out there any practical experience of doing this?
Rick Watts B.Sc, FICR, CSci
Team Lead, Clinical Research Informatics Core
Women & Children's Health Research Institute
1047 RTF, 8308 114 Street
Edmonton, AB Canada T6G 2V2
Tel: (780) 248 1170
Fax: (780) 407 1982