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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The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance, and post- marketing studies.
MetaTrial Look-Up also reduces the number of data clarification queries that must be issued and resolved because of misspellings.
GCI's requirements included auto-indexing capabilities for both case report forms and data clarification reports.
Deliver timely resolution of data discrepancies via the industry's only electronic Data Clarification Form (eDCF) system
Its case report form (CRF) scanning, data recognition and data clarification capabilities are designed to promote high volume and high quality data capture to facilitate more effective and efficient data collection, review, correction, validation, storage, retrieval, and electronic regulatory submissions.
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.
This approach ensures that data clarifications are processed efficiently and that dependent processes are not closed until clarifications are completed.
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.
Arrowhead designed the Tool in conjunction with one of its clients, a top 10 pharmaceutical company that needed a solution to streamline the time-consuming, paper-based and error-prone process of performing data clarifications.