Clinical Data Management in Early Phase Trials
AGAH Workshop, Frankfurt
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.
Content
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? This workshop gives an introduction into the basic principles of clinical data management starting from the trial protocol and ending with the completed data base. Participants will train the knowledge communicated in a practical example together with an experienced team of data managers.
Furthermore, the workshop will offer a first insight into CDISC principles, how this helps to systematically reach a high-quality data structure and in how far this is of relevance for submission procedures. The workshop has been 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.
Barbara Schug
President of AGAH e. V.
Programme
| 08:30 | Registration |
|---|---|
| 09:00 | Welcome
Barbara Schug, Oberursel/Germany |
| 09:05 | Introduction into the workshop: from protocol writing to data management – how to bridge the gap?
Relevance of study type; Interplay of persons involved from design development to practical performance and evaluation; specificities of early phase trials; relevance of adequate overarching processes and quality control procedures Barbara Schug, Oberursel/Germany |
| 09:30 | Interaction between trial protocol and CRF – how to specify precisely the data to be assessed?
What do you have to consider while writing the clinical trial protocol with regard to CRF design? How to translate the clinical trial protocol into the CRF; Different types of CRF structures; Points to consider during CRF set-up: accurate questions, clearly specified CRF entry fields, logical data collection; how to realize “ease for use” Juliana Brudel, Erfurt/Germany |
| 10:30 | Structured interplay of all relevant core documents including the trial protocol, DMP and DVP
Description of responsibilities and tasks in DMP with regard to information flow between involved parties (e. g. for PK analysis, SAE reconciliation) and data transfers from different sources to the target data base, including the medical coding process. Data cleaning (CRF related) and validation (electronic data transfers) processes based on DVP. Manfred Wargenau, Düsseldorf/Germany |
| 11:30 | Break |
| 11:45 | Introduction into CDISC standards
An introduction into basic principles Dagmar Kottig-Roth, Darmstadt/Germany |
| 12:45 | Break |
| 14:00 | Practical Exercise
Development of CRF module for different data types; consideration of data standards for data base structure; development of mock tables for statistical evaluation Juliana Brudel, Stephan Herrmann, Erfurt/Germany |
| 15:45 | Break |
| 16:00 | Data Standards for clinical data: preparation of CDISC data for submissions to regulatory authorities
Understanding regulatory review processes of CDISC data depending on regulatory authorities and kind of trials; Regulatory review environment: How are CDISC data processed at the agencies and what are standard review processes for CDISC data; Relevance of traceability from data collection to analysis; What can we learn from the regulatory review process for the data standards collection Dagmar Kottig-Roth, Darmstadt/Germany |
| 17:00 | Summarising discussion |
| 17:15 | End of Workshop |
- Juliana Brudel
Head Data Management at SocraMetrics GmbH, Erfurt, Germany - Stephan Herrmann
Head Electronic Data Capture at SocraMetrics GmbH, Erfurt - Dagmar Kottig-Roth
Principal Data Standards and Governance Manager, Global Clinical Data Sciences at Merck KGaA, Darmstadt, Germany - Barbara Schug
Managing Director at SocraTec R&D GmbH, Oberursel and at SocraMetrics GmbH, Erfurt, Germany - Manfred Wargenau
CEO, Principal Statistician and Pharmacokineticist at M.A.R.C.O. GmbH & Co. KG, Düsseldorf, Germany
- Torsten Petsching
Team Leader Clinical Data Standards Group at Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
Attendance Fee
| 450€ | Non Member |
|---|---|
| 320€ | Member of AGAH or of DGKliPha or Junior Scientist up to the age of 30 |
The participation fee is per person. Please note, according to §4 para 22 German turnover tax law, registration and workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e. V. All bookings are subject to change
Registration Deadline: November 28, 2017
A certification (CME – continuing medical education points) of the medical association Hessen is requested.
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20249 Hamburg/Germany
Phone: +49 170 7844438
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