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05.12.2017 – 06.12.2017

Veranstaltungsort: Spenerhaus, Frankfurt

Clinical Data Management in Early Phase Trials

An introduction into the principles and strategies for PK/PD and BA/BE studies in healthy subjects and patients.

Also in early phase trials the ultimate goal of Clinical Data Management is to assure that data structure, data collection and quality as well as data analysis adequately support conclusions to be drawn from clinical research. In the end high-quality data should be accurate, suitable for statistical analysis and the structure should follow internationally accepted standards.

Quality by design in clinical data management means a structured interplay of all relevant core documents including the trial protocol, CRF, DMP, DVP, SAP as well as the data base itself. 

How to ensure this already in early clinical development? Our workshop wants to give an introduction into the basic principles of clinical data management starting from the trial protocol and ending with the completed data base. The workshop will offer a first insight into CDASH principles and how this helps to systematically reach a high-quality data structure.

Who should attend? The workshop has been specifically developed for clinical investigators, project leaders and project managers, monitors and also for phase-I/II experienced study nurses with a certain IT-enthusiasm who want to better understand the principles of a good-quality data management and how they can contribute already in the planning phase to set-up a data structure following international principles. It covers questions relevant for industry-sponsored studies as well as IITs. 

We are looking forward to your registration.