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.
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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.
The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance, and post- marketing studies.
Deliver timely resolution of data discrepancies via the industry's only electronic Data Clarification Form (eDCF) system
Data Clarification Forms - Generates and tracks data clarification forms (DCF) for sponsors leveraging Rave's double data entry (DDE) capabilities.
The resubmission is intended to address the issues presented by the FDA in the December 23, 2005 Daytrana(TM) approvable letter, which included proposed revisions to labeling, as well as requests for data clarification, post-marketing surveillance, and post-marketing studies.
The approvable letter contains proposed revisions to labeling, as well as requests for data clarification, post marketing surveillance, and post-marketing studies.
PHT's enhanced StudyWorks[TM] online portal offers study sponsors an unprecedented level of management and logistical control over their clinical trials with new reporting features and online management of data clarifications.