data clarification

data clarification

In the context of a clinical trial, an answer supplied by a study investigator in response to a query by the FDA or other regulatory body. The investigator may either supply a new data point value to replace the initial value or a confirmation of the queried data point.
References in periodicals archive ?
Building immovable property cadastral measurements data clarification.
Follow-up for survey recruitment, nonresponse, and data clarification was conducted via telephone and email by experienced interviewers from September 2011 through January 2012.
This chapter also discusses proper documentation, including how to correct errors and answer queries and data clarification forms.
The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance, and post- marketing studies.